Trial Outcomes & Findings for Transversus Abdominis Plane Block Versus Erector Spinae Plane Block (NCT NCT03989570)
NCT ID: NCT03989570
Last Updated: 2020-06-30
Results Overview
the pain will be assisted based on the time for the first dose of rescue analgesia
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
24 hours
Results posted on
2020-06-30
Participant Flow
7 patient refuse to participate
Participant milestones
| Measure |
Group I (A Group)
31 patients Will undergo ESP block with 40 ml bupivacine 0.25% (20 ml on each side), and TAP block with 40 ml saline 0.9% (20 ml on each side).
erector spinae plane block: The ESP block will be performed into a fascial plane between the deep surface of erector spinae muscle and the transverse processes
|
Group II (B Group)
31patients Will undergo TAP block with 40 ml bupivacine 0.25% (20 ml on each side), and ESP block with 40 ml saline 0.9% (20 ml on each side).
transversus abdominis plane block: The TAP block will be performed laterally behind the midaxillary line between the iliac crest and the most inferior extent of the ribs. The plane between the internal oblique and transversus abdominis muscle will be located around the midaxillary line with the probe transverse to the abdomen. Anteriorly,The needle will be passed to come in plane with the ultrasound beam and placed between transversus and internal oblique posterior to the midaxillary line then, the local anesthetic will be injected
|
Group III (C Group)
31 patients anesthetized with the protocol followed by Minia University Hospital
control group: placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
31
|
31
|
31
|
|
Overall Study
COMPLETED
|
31
|
31
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transversus Abdominis Plane Block Versus Erector Spinae Plane Block
Baseline characteristics by cohort
| Measure |
Group I (A Group)
n=31 Participants
31 patients Will undergo ESP block with 40 ml bupivacine 0.25% (20 ml on each side), and TAP block with 40 ml saline 0.9% (20 ml on each side).
erector spinae plane block: The ESP block will be performed into a fascial plane between the deep surface of erector spinae muscle and the transverse processes
|
Group II (B Group)
n=31 Participants
31patients Will undergo TAP block with 40 ml bupivacine 0.25% (20 ml on each side), and ESP block with 40 ml saline 0.9% (20 ml on each side).
transversus abdominis plane block: The TAP block will be performed laterally behind the midaxillary line between the iliac crest and the most inferior extent of the ribs. The plane between the internal oblique and transversus abdominis muscle will be located around the midaxillary line with the probe transverse to the abdomen. Anteriorly,The needle will be passed to come in plane with the ultrasound beam and placed between transversus and internal oblique posterior to the midaxillary line then, the local anesthetic will be injected
|
Group III (C Group)
n=31 Participants
31 patients anesthetized with the protocol followed by Minia University Hospital
control group: placebo
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.8 years
STANDARD_DEVIATION 14.9 • n=5 Participants
|
47.4 years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
43.6 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
45.61 years
STANDARD_DEVIATION 13.46 • n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Egypt
|
31 participants
n=5 Participants
|
31 participants
n=7 Participants
|
31 participants
n=5 Participants
|
93 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 24 hoursthe pain will be assisted based on the time for the first dose of rescue analgesia
Outcome measures
| Measure |
Group I (A Group)
n=31 Participants
31 patients Will undergo ESP block with 40 ml bupivacine 0.25% (20 ml on each side), and TAP block with 40 ml saline 0.9% (20 ml on each side).
erector spinae plane block: The ESP block will be performed into a fascial plane between the deep surface of erector spinae muscle and the transverse processes
|
Group II (B Group)
n=31 Participants
31patients Will undergo TAP block with 40 ml bupivacine 0.25% (20 ml on each side), and ESP block with 40 ml saline 0.9% (20 ml on each side).
transversus abdominis plane block: The TAP block will be performed laterally behind the midaxillary line between the iliac crest and the most inferior extent of the ribs. The plane between the internal oblique and transversus abdominis muscle will be located around the midaxillary line with the probe transverse to the abdomen. Anteriorly,The needle will be passed to come in plane with the ultrasound beam and placed between transversus and internal oblique posterior to the midaxillary line then, the local anesthetic will be injected
|
Group III (C Group)
n=31 Participants
31 patients anesthetized with the protocol followed by Minia University Hospital
control group: placebo
|
|---|---|---|---|
|
Time of First Post Operative Analgesic Request
|
14.9 Hour
Standard Deviation 5.7
|
6.5 Hour
Standard Deviation 2.2
|
2.8 Hour
Standard Deviation 1.6
|
PRIMARY outcome
Timeframe: 24 hoursThe total amount of postoperative fentanyl in milligram was given to the patient as rescue analgesia during 24 hours
Outcome measures
| Measure |
Group I (A Group)
n=31 Participants
31 patients Will undergo ESP block with 40 ml bupivacine 0.25% (20 ml on each side), and TAP block with 40 ml saline 0.9% (20 ml on each side).
erector spinae plane block: The ESP block will be performed into a fascial plane between the deep surface of erector spinae muscle and the transverse processes
|
Group II (B Group)
n=31 Participants
31patients Will undergo TAP block with 40 ml bupivacine 0.25% (20 ml on each side), and ESP block with 40 ml saline 0.9% (20 ml on each side).
transversus abdominis plane block: The TAP block will be performed laterally behind the midaxillary line between the iliac crest and the most inferior extent of the ribs. The plane between the internal oblique and transversus abdominis muscle will be located around the midaxillary line with the probe transverse to the abdomen. Anteriorly,The needle will be passed to come in plane with the ultrasound beam and placed between transversus and internal oblique posterior to the midaxillary line then, the local anesthetic will be injected
|
Group III (C Group)
n=31 Participants
31 patients anesthetized with the protocol followed by Minia University Hospital
control group: placebo
|
|---|---|---|---|
|
Postoperative Total Fentanyl Requirement
|
40.3 Milligram
Standard Deviation 26.7
|
111 Milligram
Standard Deviation 38.1
|
175 Milligram
Standard Deviation 38.9
|
SECONDARY outcome
Timeframe: 5 daysadverse events related to technique or drugs
Outcome measures
| Measure |
Group I (A Group)
n=31 Participants
31 patients Will undergo ESP block with 40 ml bupivacine 0.25% (20 ml on each side), and TAP block with 40 ml saline 0.9% (20 ml on each side).
erector spinae plane block: The ESP block will be performed into a fascial plane between the deep surface of erector spinae muscle and the transverse processes
|
Group II (B Group)
n=31 Participants
31patients Will undergo TAP block with 40 ml bupivacine 0.25% (20 ml on each side), and ESP block with 40 ml saline 0.9% (20 ml on each side).
transversus abdominis plane block: The TAP block will be performed laterally behind the midaxillary line between the iliac crest and the most inferior extent of the ribs. The plane between the internal oblique and transversus abdominis muscle will be located around the midaxillary line with the probe transverse to the abdomen. Anteriorly,The needle will be passed to come in plane with the ultrasound beam and placed between transversus and internal oblique posterior to the midaxillary line then, the local anesthetic will be injected
|
Group III (C Group)
n=31 Participants
31 patients anesthetized with the protocol followed by Minia University Hospital
control group: placebo
|
|---|---|---|---|
|
Incidence of Any Adverse Events
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Group I (A Group)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group II (B Group)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group III (C Group)
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place