Trial Outcomes & Findings for Comparative Study of Two Different Techniques to Perform TAP-blocks (NCT NCT02571439)

Results Overview

Two independent observers (who are not the surgeon or anesthesiologist performing the procedures) will collect data on time outcomes to reduce error and the procedure will be filmed on a random sample of 10% of patients to verify the times assigned by the study personnel. Filming will be started after the patient is draped so that the patients face is not in the recording.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

41 participants

Primary outcome timeframe

The time taken to perform the block in the operating room is measured, upto 60 minutes

Results posted on

2018-08-03

Participant Flow

Due to recruitment proceeding slower than expected and study personnel relocating from the study site, we closed the study before recruitment of planned number of subjects

Participant milestones

Participant milestones
Measure	Surgical TAP Block surgeon administered intraoperative TAP block using 0.5% ropivacaine Surgical TAP block: surgeon administered TAP block 0.5% ropivacaine: 20ml of 0.5% ropivacaine is used to perform the TAP block	Conventional TAP Block Conventional, Anesthesiologist administered post-operative TAP block using 0.5% ropivacaine Conventional TAP block: Anesthesiologist administered TAP block 0.5% ropivacaine: 20ml of 0.5% ropivacaine is used to perform the TAP block
Overall Study STARTED	20	21
Overall Study COMPLETED	20	21
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparative Study of Two Different Techniques to Perform TAP-blocks

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Surgical TAP n=20 Participants Intra-operative TAP block	Conventional TAP n=21 Participants Percutaneous ultrasound guided TAP block	Total n=41 Participants Total of all reporting groups
Age, Continuous	29.1 years STANDARD_DEVIATION 4.0 • n=5 Participants	32.2 years STANDARD_DEVIATION 5.4 • n=7 Participants	30.7 years STANDARD_DEVIATION 4.9 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	21 Participants n=7 Participants	41 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants	21 Participants n=7 Participants	41 Participants n=5 Participants
BMI	31.2 Kg/m^2 STANDARD_DEVIATION 5.6 • n=5 Participants	30.7 Kg/m^2 STANDARD_DEVIATION 6.5 • n=7 Participants	31.0 Kg/m^2 STANDARD_DEVIATION 6.0 • n=5 Participants
Previous abdominal surgery Yes	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants
Previous abdominal surgery No	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: The time taken to perform the block in the operating room is measured, upto 60 minutes

Two independent observers (who are not the surgeon or anesthesiologist performing the procedures) will collect data on time outcomes to reduce error and the procedure will be filmed on a random sample of 10% of patients to verify the times assigned by the study personnel. Filming will be started after the patient is draped so that the patients face is not in the recording.

Outcome measures

Outcome measures
Measure	Surgical TAP Block n=20 Participants surgeon administered intraoperative TAP block using 0.5% ropivacaine Surgical TAP block: surgeon administered TAP block 0.5% ropivacaine: 20ml of 0.5% ropivacaine is used to perform the TAP block	Conventional TAP Block n=21 Participants Conventional, Anesthesiologist administered post-operative TAP block using 0.5% ropivacaine Conventional TAP block: Anesthesiologist administered TAP block 0.5% ropivacaine: 20ml of 0.5% ropivacaine is used to perform the TAP block
Time Taken to Perform the Block	2.4 minutes Standard Deviation 0.5	12.1 minutes Standard Deviation 5.1

SECONDARY outcome

Timeframe: Time measures will be recorded in the operating room, upto 6 hours

Two independent observers (who are not the surgeon or anesthesiologist performing the procedures) will collect data on time outcomes to reduce error and the procedure will be filmed on a random sample of 10% of patients to verify the times assigned by the study personnel. Filming will be started after the patient is draped so that the patients face is not in the recording.

Outcome measures

Outcome measures
Measure	Surgical TAP Block n=20 Participants surgeon administered intraoperative TAP block using 0.5% ropivacaine Surgical TAP block: surgeon administered TAP block 0.5% ropivacaine: 20ml of 0.5% ropivacaine is used to perform the TAP block	Conventional TAP Block n=21 Participants Conventional, Anesthesiologist administered post-operative TAP block using 0.5% ropivacaine Conventional TAP block: Anesthesiologist administered TAP block 0.5% ropivacaine: 20ml of 0.5% ropivacaine is used to perform the TAP block
Time From Delivery of Neonate to Ready to Exit Operating Room	55.3 minutes Standard Deviation 10.2	77.9 minutes Standard Deviation 18.9

SECONDARY outcome

Timeframe: 4 hours after surgery

postoperative pain will be assessed using the visual analog scale postoperatively at 4 hours after surgery. visual analog pain scale is a response scale to measure pain with a score of 0 representing no pain and a score of 10 representing the worst pain imaginable. The minimum value was 0 for no pain and maximum value was 10 for the worst pain imaginable. The responses are whole numbers ranging from 0 to 10 with increasing numbers representing increasing pain.

Outcome measures

Outcome measures
Measure	Surgical TAP Block n=20 Participants surgeon administered intraoperative TAP block using 0.5% ropivacaine Surgical TAP block: surgeon administered TAP block 0.5% ropivacaine: 20ml of 0.5% ropivacaine is used to perform the TAP block	Conventional TAP Block n=21 Participants Conventional, Anesthesiologist administered post-operative TAP block using 0.5% ropivacaine Conventional TAP block: Anesthesiologist administered TAP block 0.5% ropivacaine: 20ml of 0.5% ropivacaine is used to perform the TAP block
Severity of Postoperative Pain at Rest	4 Numerical rating scale for pain Interval 2.0 to 5.0	3 Numerical rating scale for pain Interval 2.0 to 6.0

SECONDARY outcome

Timeframe: 8 hours after surgery

postoperative pain will be assessed using the visual analog scale postoperatively at 8 hours after surgery. v

Outcome measures

Outcome measures
Measure	Surgical TAP Block n=20 Participants surgeon administered intraoperative TAP block using 0.5% ropivacaine Surgical TAP block: surgeon administered TAP block 0.5% ropivacaine: 20ml of 0.5% ropivacaine is used to perform the TAP block	Conventional TAP Block n=21 Participants Conventional, Anesthesiologist administered post-operative TAP block using 0.5% ropivacaine Conventional TAP block: Anesthesiologist administered TAP block 0.5% ropivacaine: 20ml of 0.5% ropivacaine is used to perform the TAP block
Severity of Postoperative Pain at Rest	4 Units on a scale Interval 2.0 to 5.0	3 Units on a scale Interval 2.0 to 5.0

SECONDARY outcome

Timeframe: 24 hours after surgery

postoperative pain will be assessed using the visual analog scale postoperatively at 24 hours after surgery. v

Outcome measures

Outcome measures
Measure	Surgical TAP Block n=20 Participants surgeon administered intraoperative TAP block using 0.5% ropivacaine Surgical TAP block: surgeon administered TAP block 0.5% ropivacaine: 20ml of 0.5% ropivacaine is used to perform the TAP block	Conventional TAP Block n=21 Participants Conventional, Anesthesiologist administered post-operative TAP block using 0.5% ropivacaine Conventional TAP block: Anesthesiologist administered TAP block 0.5% ropivacaine: 20ml of 0.5% ropivacaine is used to perform the TAP block
Severity of Postoperative Pain at Rest	2 Units on a scale Interval 0.0 to 4.0	3 Units on a scale Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: 48 hours after surgery

postoperative pain will be assessed using the visual analog scale postoperatively at 48 hours after surgery.

Outcome measures

Outcome measures
Measure	Surgical TAP Block n=20 Participants surgeon administered intraoperative TAP block using 0.5% ropivacaine Surgical TAP block: surgeon administered TAP block 0.5% ropivacaine: 20ml of 0.5% ropivacaine is used to perform the TAP block	Conventional TAP Block n=21 Participants Conventional, Anesthesiologist administered post-operative TAP block using 0.5% ropivacaine Conventional TAP block: Anesthesiologist administered TAP block 0.5% ropivacaine: 20ml of 0.5% ropivacaine is used to perform the TAP block
Severity of Postoperative Pain at Rest	2 Units on a scale Interval 0.0 to 5.0	0 Units on a scale Interval 0.0 to 2.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 hours after surgery

Total narcotic consumption, measured in mg of morphine 24 hours after surgery

Outcome measures

Outcome measures
Measure	Surgical TAP Block n=20 Participants surgeon administered intraoperative TAP block using 0.5% ropivacaine Surgical TAP block: surgeon administered TAP block 0.5% ropivacaine: 20ml of 0.5% ropivacaine is used to perform the TAP block	Conventional TAP Block n=21 Participants Conventional, Anesthesiologist administered post-operative TAP block using 0.5% ropivacaine Conventional TAP block: Anesthesiologist administered TAP block 0.5% ropivacaine: 20ml of 0.5% ropivacaine is used to perform the TAP block
Total Narcotic Consumption	28 mg of morphine Interval 20.0 to 51.0	25 mg of morphine Interval 9.0 to 38.0

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 24 hours after surgery

sedation will be assessed postoperatively on a scale of 0 to 10. The minimum value was 0 for not sedated or awake and maximum value was 10 for extremely sedated. The responses are whole numbers ranging from 0 to 10 with increasing numbers representing increasing sedation.

Outcome measures

Outcome measures
Measure	Surgical TAP Block n=20 Participants surgeon administered intraoperative TAP block using 0.5% ropivacaine Surgical TAP block: surgeon administered TAP block 0.5% ropivacaine: 20ml of 0.5% ropivacaine is used to perform the TAP block	Conventional TAP Block n=21 Participants Conventional, Anesthesiologist administered post-operative TAP block using 0.5% ropivacaine Conventional TAP block: Anesthesiologist administered TAP block 0.5% ropivacaine: 20ml of 0.5% ropivacaine is used to perform the TAP block
Sedation	2.5 scale of 0-10 Interval 0.0 to 7.5	3 scale of 0-10 Interval 0.0 to 6.0

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 24 hours after surgery

outcomes will be assessed postoperatively as number of patients with postoperative nausea/vomiting "present" or "not present" at 24 hours after surgery

Outcome measures

Outcome measures
Measure	Surgical TAP Block n=20 Participants surgeon administered intraoperative TAP block using 0.5% ropivacaine Surgical TAP block: surgeon administered TAP block 0.5% ropivacaine: 20ml of 0.5% ropivacaine is used to perform the TAP block	Conventional TAP Block n=21 Participants Conventional, Anesthesiologist administered post-operative TAP block using 0.5% ropivacaine Conventional TAP block: Anesthesiologist administered TAP block 0.5% ropivacaine: 20ml of 0.5% ropivacaine is used to perform the TAP block
Number of Participants With Postoperative Nausea/Vomiting	3 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 24 hours after surgery

Itching will be assessed postoperatively on a scale of 0 to 10 at 24 hours after surgery. The minimum value was 0 for no itching and maximum value was 10 for severe itching. The responses are whole numbers ranging from 0 to 10 with increasing numbers representing increasing itching.

Outcome measures

Outcome measures
Measure	Surgical TAP Block n=20 Participants surgeon administered intraoperative TAP block using 0.5% ropivacaine Surgical TAP block: surgeon administered TAP block 0.5% ropivacaine: 20ml of 0.5% ropivacaine is used to perform the TAP block	Conventional TAP Block n=21 Participants Conventional, Anesthesiologist administered post-operative TAP block using 0.5% ropivacaine Conventional TAP block: Anesthesiologist administered TAP block 0.5% ropivacaine: 20ml of 0.5% ropivacaine is used to perform the TAP block
Itching.	0 scale of 0-10 Interval 0.0 to 2.5	0 scale of 0-10 Interval 0.0 to 3.0

Adverse Events

Surgical TAP Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Conventional TAP Block

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

Dr Kalpana Tyagaraj

Maimonides Medical Center

Phone: 7182836000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place