Trial Outcomes & Findings for Fluoroscopy-guided Versus Traditional Placement of Epidural Catheters (NCT NCT02678039)

NCT ID: NCT02678039

Last Updated: 2017-09-12

Results Overview

Outcome measure is mg of morphine equivalent used in first 24 hours after surgery: Postoperative pain medication use during the first 24 postoperative hours will be calculated by converting medication to an equivalent amount of morphine. This is an indirect measure of postoperative pain.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 100 participants
• Primary outcome timeframe: 24 hours after surgery
• Results posted on: 2017-09-12

Participant Flow

Participant milestones

Measure	Traditional The traditional approach for placement of an epidural catheter is indirect indicators of placement including palpation of spine and 'loss-of-resistance' to fluid injection. Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr into the epidural catheter for pain control. Traditional: An epidural catheter is placed before surgery with the patient sitting. The catheter is placed using indirect indicators of placement: depth of needle and ability to inject solution through the needle ('loss of resistance'). After needle placement in the epidural space, an epidural catheter is threaded through the needle and the needle removed. After catheter is placed, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected to exclude intravascular placement. A continuous infusion of 1/8% bupivacaine is started at 4ml/hr. The bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusion rate by 2ml/hr up to a maximum of 14ml/hr.	Fluoroscopy Real-time fluoroscopic X-ray guidance to confirm placement of an epidural catheter in the epidural space at the desired location. Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr during and after surgery for pain control. Fluoroscopy: Device: Fluoroscopy Patients lie prone on X-ray compatible operating table and an X-ray device obtains X-ray images of catheter placement. An epidural catheter is placed with local anesthesia as a needle that is advanced into the epidural space. A catheter is then placed through the needle to the desired location and the needle is removed. After the catheter is placed, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. The bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusion rate by 2ml/hr up to a maximum of 14ml/hr
Overall Study STARTED	53	47
Overall Study COMPLETED	53	47
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fluoroscopy-guided Versus Traditional Placement of Epidural Catheters

Baseline characteristics by cohort

Measure	Fluoroscopy n=47 Participants Real-time fluoroscopic X-ray guidance to confirm placement of epidural catheter in the epidural space at the desired location. Following epidural catheter placement 1/8% bupivacaine is infused at 4ml/hr during and after surgery for pain control. Fluoroscopy: Device: Fluoroscopy Patients lie prone on X-ray compatible operating table and an X-ray device obtains images of epidural catheter placement. An epidural catheter is placed with local anesthesia as a needle that is advanced into the epidural space. A catheter is then placed through the needle to the desired location and the needle is removed. After the catheter is placed, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusion rate by 2ml/hr up to a maximum of 14ml/hr	Traditional n=53 Participants The traditional approach for placement of an epidural catheter is with indirect indicators including palpation of spine and 'loss-of-resistance' to fluid injection. Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr during and after surgery for pain control. Traditional: An epidural catheter is placed before surgery with the patient sitting. The catheter is placed using indirect indicators of proper placement: depth of needle insertion and ability to inject solution through the needle ('loss of resistance'). After needle placement, an epidural catheter is threaded through the needle and the needle removed. After catheter is placement, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected to exclude intravascular placement. A continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusion rate by 2ml/hr up to a maximum of 14ml/hr.	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	34 Participants n=7 Participants	59 Participants n=5 Participants
Age, Categorical >=65 years	22 Participants n=5 Participants	19 Participants n=7 Participants	41 Participants n=5 Participants
Age, Continuous	65.2 years STANDARD_DEVIATION 10.6 • n=5 Participants	64.9 years STANDARD_DEVIATION 8.9 • n=7 Participants	65.1 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	29 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	24 Participants n=7 Participants	49 Participants n=5 Participants
Region of Enrollment United States	47 participants n=5 Participants	53 participants n=7 Participants	100 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours after surgery

Outcome measure is mg of morphine equivalent used in first 24 hours after surgery: Postoperative pain medication use during the first 24 postoperative hours will be calculated by converting medication to an equivalent amount of morphine. This is an indirect measure of postoperative pain.

Outcome measures

Measure	Fluoroscopy n=47 Participants Real-time fluoroscopic X-ray guidance to confirm placement of an epidural catheter. Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr into the epidural catheter during and after surgery for pain control. Fluoroscopy: Device: Fluoroscopy Patients lie prone on X-ray compatible operating table and an X-ray device obtains X-ray images of epidural catheter placement. An epidural catheter is placed with local anesthesia as a needle that is advanced into the epidural space. A catheter is then placed through the needle to the desired location and the needle is removed. After the catheter is placed, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusi	Traditional n=53 Participants The traditional approach for placement of an epidural catheter is used with indirect indicators of placement including palpation of spine and 'loss-of-resistance' to fluid injection. Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr into the epidural catheter during and after surgery for pain control. Traditional:An epidural catheter is placed before surgery with the patient sitting at bedside. The catheter is placed with local anesthesia using indirect indicators of proper placement: depth of needle insertion and ability to inject solution through the needle ('loss of resistance'). After needle placement in the epidural space, an epidural catheter is threaded through the needle 3-4 cm and the needle removed. After catheter is placement, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the b
Intravenous Pain Medication	63 milligrams Standard Deviation 33	66 milligrams Standard Deviation 27

SECONDARY outcome

Timeframe: 24 hours after surgery

Percent of epidural catheters that were correctly placed (percentage of catheters).

Outcome measures

Measure	Fluoroscopy n=47 Participants Real-time fluoroscopic X-ray guidance to confirm placement of an epidural catheter. Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr into the epidural catheter during and after surgery for pain control. Fluoroscopy: Device: Fluoroscopy Patients lie prone on X-ray compatible operating table and an X-ray device obtains X-ray images of epidural catheter placement. An epidural catheter is placed with local anesthesia as a needle that is advanced into the epidural space. A catheter is then placed through the needle to the desired location and the needle is removed. After the catheter is placed, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusi	Traditional n=53 Participants The traditional approach for placement of an epidural catheter is used with indirect indicators of placement including palpation of spine and 'loss-of-resistance' to fluid injection. Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr into the epidural catheter during and after surgery for pain control. Traditional:An epidural catheter is placed before surgery with the patient sitting at bedside. The catheter is placed with local anesthesia using indirect indicators of proper placement: depth of needle insertion and ability to inject solution through the needle ('loss of resistance'). After needle placement in the epidural space, an epidural catheter is threaded through the needle 3-4 cm and the needle removed. After catheter is placement, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the b
Incidence of Epidural Catheter Failure	74 percentage of catheters	98 percentage of catheters

SECONDARY outcome

Timeframe: Measured at 24 hours after surgery

Assessment of pain intensity by verbal report of patient on a digital scale of 0 (no pain) to 10 (worst pain).

Outcome measures

Measure	Fluoroscopy n=47 Participants Real-time fluoroscopic X-ray guidance to confirm placement of an epidural catheter. Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr into the epidural catheter during and after surgery for pain control. Fluoroscopy: Device: Fluoroscopy Patients lie prone on X-ray compatible operating table and an X-ray device obtains X-ray images of epidural catheter placement. An epidural catheter is placed with local anesthesia as a needle that is advanced into the epidural space. A catheter is then placed through the needle to the desired location and the needle is removed. After the catheter is placed, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusi	Traditional n=53 Participants The traditional approach for placement of an epidural catheter is used with indirect indicators of placement including palpation of spine and 'loss-of-resistance' to fluid injection. Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr into the epidural catheter during and after surgery for pain control. Traditional:An epidural catheter is placed before surgery with the patient sitting at bedside. The catheter is placed with local anesthesia using indirect indicators of proper placement: depth of needle insertion and ability to inject solution through the needle ('loss of resistance'). After needle placement in the epidural space, an epidural catheter is threaded through the needle 3-4 cm and the needle removed. After catheter is placement, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the b
Postoperative Pain Intensity Measured by Numeric Scale	6.3 units on a scale of 0 to 10 Standard Deviation 3.1	6.6 units on a scale of 0 to 10 Standard Deviation 3.4

SECONDARY outcome

Timeframe: Measured at 48 hours after surgery

Assessment of pain intensity by verbal report of patient on a digital scale of 0 (no pain) to 10 (worst pain).

Outcome measures

Measure	Fluoroscopy n=47 Participants Real-time fluoroscopic X-ray guidance to confirm placement of an epidural catheter. Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr into the epidural catheter during and after surgery for pain control. Fluoroscopy: Device: Fluoroscopy Patients lie prone on X-ray compatible operating table and an X-ray device obtains X-ray images of epidural catheter placement. An epidural catheter is placed with local anesthesia as a needle that is advanced into the epidural space. A catheter is then placed through the needle to the desired location and the needle is removed. After the catheter is placed, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusi	Traditional n=53 Participants The traditional approach for placement of an epidural catheter is used with indirect indicators of placement including palpation of spine and 'loss-of-resistance' to fluid injection. Following epidural catheter placement, 1/8% bupivacaine is infused at 4ml/hr into the epidural catheter during and after surgery for pain control. Traditional:An epidural catheter is placed before surgery with the patient sitting at bedside. The catheter is placed with local anesthesia using indirect indicators of proper placement: depth of needle insertion and ability to inject solution through the needle ('loss of resistance'). After needle placement in the epidural space, an epidural catheter is threaded through the needle 3-4 cm and the needle removed. After catheter is placement, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the b
Postoperative Pain Intensity Measured by Numeric Scale	6.4 milligrams Standard Deviation 3.3	6.8 milligrams Standard Deviation 2.7

SECONDARY outcome

Timeframe: 3 months after surgery during follow up office visit with surgeon

Population: Insufficient data were collected for this analysis

Assessment of pain intensity by verbal report of patient on a digital scale of 0 (no pain) to 10 (worst pain).

Outcome measures

Outcome data not reported

Adverse Events

Fluoroscopy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Traditional

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

Mark P. Yeager, MD

Dartmouth-Hitchcock

Phone: 603-650-5922

Email: mark.p.yeager@hitchcock.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place