Trial Outcomes & Findings for Comparison Study of Transversus Abdominal Plane, Paravertebral and Epidural Blocks in Laparoscopic Colectomy (NCT NCT02164929)

Results Overview

If opioid other than fentanyl is used, the dose will be converted to morphine equivalent.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

17 participants

Primary outcome timeframe

24 hours after surgery

Results posted on

2017-09-25

Participant Flow

Of the 17 patients that consented, one patient withdrew before randomization

Participant milestones

Participant milestones
Measure	Paravertebral Block Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total). Paravertebral block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%	TAP Block Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). TAP block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%	Epidural An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements. Epidural Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropi	No Block (PCA Alone) Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%
Overall Study STARTED	4	3	5	4
Overall Study COMPLETED	3	3	4	2
Overall Study NOT COMPLETED	1	0	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Paravertebral Block Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total). Paravertebral block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%	TAP Block Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). TAP block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%	Epidural An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements. Epidural Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropi	No Block (PCA Alone) Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%
Overall Study Converted to open procedure	1	0	0	2
Overall Study Failed regional block	0	0	1	0

Baseline Characteristics

Comparison Study of Transversus Abdominal Plane, Paravertebral and Epidural Blocks in Laparoscopic Colectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	No Block (PCA Alone) n=4 Participants Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%	Total n=15 Participants Total of all reporting groups	Paravertebral Block n=4 Participants Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total). Paravertebral block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%	TAP Block n=3 Participants Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). TAP block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%	Epidural n=4 Participants An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements. Epidural Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropi
Age, Continuous	52 years STANDARD_DEVIATION 21.9 • n=483 Participants	54.2 years STANDARD_DEVIATION 12.9 • n=36 Participants	55.5 years STANDARD_DEVIATION 8.5 • n=93 Participants	51 years STANDARD_DEVIATION 15 • n=4 Participants	57.75 years STANDARD_DEVIATION 6.6 • n=27 Participants
Sex: Female, Male Female	2 Participants n=483 Participants	7 Participants n=36 Participants	2 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Sex: Female, Male Male	2 Participants n=483 Participants	8 Participants n=36 Participants	2 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants

PRIMARY outcome

Timeframe: 24 hours after surgery

If opioid other than fentanyl is used, the dose will be converted to morphine equivalent.

Outcome measures

Outcome measures
Measure	Paravertebral Block n=3 Participants Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total). Paravertebral block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%	TAP Block n=3 Participants Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). TAP block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%	Epidural n=4 Participants An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements. Epidural Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropi	No Block (PCA Alone) n=2 Participants Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%
Postoperative Opioid Consumption	734 mcg Standard Deviation 422	666 mcg Standard Deviation 474	125 mcg Standard Deviation 50	1017.5 mcg Standard Deviation 484

SECONDARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, an estimated 1 week

Pain scores at rest and with activity using a verbal rating scales (VRS) of 0-10, where "0" represents no pain and "10" represents worst pain ever, at 30, 60, 90, 120 min and every 6 hours for 24 hours and every 12 hours for 48 hours and once a day thereafter until discharge. Data were collected at the indicated time points and an average pain score was calculated.

Outcome measures

Outcome measures
Measure	Paravertebral Block n=3 Participants Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total). Paravertebral block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%	TAP Block n=3 Participants Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). TAP block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%	Epidural n=4 Participants An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements. Epidural Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropi	No Block (PCA Alone) n=2 Participants Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%
Pain Scores	4.66 Units on a scale Standard Deviation 1.15	2.66 Units on a scale Standard Deviation 1.52	1.75 Units on a scale Standard Deviation 1.25	6 Units on a scale Standard Deviation 2.82

SECONDARY outcome

Timeframe: 72 hours

Quality of Recovery Score (QoR-15) is measured on a scale of 0-150 (0=poor, 150 = excellent). Scores were collected daily for 72 hours and then averaged.

Outcome measures

Outcome measures
Measure	Paravertebral Block n=3 Participants Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total). Paravertebral block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%	TAP Block n=3 Participants Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). TAP block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%	Epidural n=4 Participants An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements. Epidural Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropi	No Block (PCA Alone) n=2 Participants Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%
Quality of Recovery	89.5 Units on a scale Standard Deviation 10.6	117 Units on a scale Standard Deviation 23.3	115.5 Units on a scale Standard Deviation 0.7	99 Units on a scale Standard Deviation 17.6

SECONDARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, an estimated 1 week

Population: Data not collected

Complications using a Modified Postoperative Morbidity Survey (MPMS)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, an estimated 1 week

Outcome measures

Outcome measures
Measure	Paravertebral Block n=3 Participants Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total). Paravertebral block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%	TAP Block n=3 Participants Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). TAP block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%	Epidural n=4 Participants An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements. Epidural Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropi	No Block (PCA Alone) n=2 Participants Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%
Time to First Bowel Movement	1 days Standard Deviation 1.4	2 days Standard Deviation 0.7	1 days Standard Deviation 0.8	2 days Standard Deviation 0

SECONDARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, an estimated 1 week

Occurrence and duration of opioid related adverse events including postoperative nausea and vomiting (PONV); pruritus, urinary retention, confusion, sedation and respiratory depression at the above time points.

Outcome measures

Outcome measures
Measure	Paravertebral Block n=3 Participants Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total). Paravertebral block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%	TAP Block n=3 Participants Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). TAP block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%	Epidural n=4 Participants An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements. Epidural Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropi	No Block (PCA Alone) n=2 Participants Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%
Opioid Related Side Effects	0 side effects	0 side effects	0 side effects	0 side effects

SECONDARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, an estimated 1 week

Outcome measures

Outcome measures
Measure	Paravertebral Block n=3 Participants Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total). Paravertebral block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%	TAP Block n=3 Participants Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). TAP block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%	Epidural n=4 Participants An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements. Epidural Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropi	No Block (PCA Alone) n=2 Participants Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%
Time to First Ingestion of Solid Food	1 Days Standard Deviation 0	2 Days Standard Deviation 0.7	0.75 Days Standard Deviation 0.5	1.5 Days Standard Deviation 0.7

SECONDARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, an estimated 1 week

Outcome measures

Outcome measures
Measure	Paravertebral Block n=3 Participants Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total). Paravertebral block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%	TAP Block n=3 Participants Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). TAP block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%	Epidural n=4 Participants An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements. Epidural Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropi	No Block (PCA Alone) n=2 Participants Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%
Number of Epidural-related Side Effects	0 Number of side effects	0 Number of side effects	0 Number of side effects	0 Number of side effects

SECONDARY outcome

Timeframe: Participants will be followed for the duration of hospital stay, an estimated 1 week

Outcome measures

Outcome measures
Measure	Paravertebral Block n=3 Participants Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total). Paravertebral block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%	TAP Block n=3 Participants Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). TAP block Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%	Epidural n=4 Participants An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally). A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements. Epidural Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropi	No Block (PCA Alone) n=2 Participants Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure Acetaminophen 1g IV Dexamethasone 4mg Midazolam up to 2mg Propofol 1-2.5 mg/kg Sevoflurane to keep a bispectral index of between 40-60 Local infiltration with 10 mL of plain ropivacaine 0.25%
Length of Stay	2.66 Days Standard Deviation 0.57	4.33 Days Standard Deviation 3.21	4 Days Standard Deviation 1.41	3.5 Days Standard Deviation 0.7

Adverse Events

Paravertebral Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

TAP Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Epidural

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Block (PCA Alone)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Timothy Miller, MD

Duke University Medical Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place