Trial Outcomes & Findings for Efficacy of Transversus Abdominis Plane Block Versus Local Injection of Pain Medication (NCT NCT02314104)

NCT ID: NCT02314104

Last Updated: 2015-04-14

Results Overview

A Visual Analogue Scale was used. The scale range was 0 to 10 in increments of one. 0 was no pain and 10 was worst pain possible.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 220 participants
• Primary outcome timeframe: one hour postoperatively
• Results posted on: 2015-04-14

Participant Flow

Participant milestones

Measure	Treatment TAP, Placebo Local Injection Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site. ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally.	Placebo TAP, Treatment Local Injection Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally.	Treatment TAP, Treatment Local Injection Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally.
Overall Study STARTED	71	78	71
Overall Study COMPLETED	57	58	53
Overall Study NOT COMPLETED	14	20	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Transversus Abdominis Plane Block Versus Local Injection of Pain Medication

Baseline characteristics by cohort

Measure	Treatment TAP, Placebo Local Injection n=61 Participants Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site. ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally.	Placebo TAP, Treatment Local Injection n=63 Participants Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally.	Treatment TAP, Treatment Local Injection n=59 Participants Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally.	Total n=183 Participants Total of all reporting groups
Age, Continuous	53.8 years STANDARD_DEVIATION 11.3 • n=5 Participants	52.0 years STANDARD_DEVIATION 9.9 • n=7 Participants	56.1 years STANDARD_DEVIATION 11.0 • n=5 Participants	54.0 years STANDARD_DEVIATION 10.7 • n=4 Participants
Sex: Female, Male Female	61 Participants n=5 Participants	63 Participants n=7 Participants	59 Participants n=5 Participants	183 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	61 participants n=5 Participants	63 participants n=7 Participants	59 participants n=5 Participants	183 participants n=4 Participants
BMI (m/kg2)	30.5 kg/m^2 STANDARD_DEVIATION 7.4 • n=5 Participants	31.9 kg/m^2 STANDARD_DEVIATION 7.0 • n=7 Participants	29.9 kg/m^2 STANDARD_DEVIATION 7.5 • n=5 Participants	30.8 kg/m^2 STANDARD_DEVIATION 7.3 • n=4 Participants
Weight (kg)	80.8 kg STANDARD_DEVIATION 20.5 • n=5 Participants	85.9 kg STANDARD_DEVIATION 18.4 • n=7 Participants	79.2 kg STANDARD_DEVIATION 20.0 • n=5 Participants	82.0 kg STANDARD_DEVIATION 19.6 • n=4 Participants
Height (inches)	64 inches STANDARD_DEVIATION 2.6 • n=5 Participants	64.7 inches STANDARD_DEVIATION 2.5 • n=7 Participants	64.1 inches STANDARD_DEVIATION 2.5 • n=5 Participants	64.3 inches STANDARD_DEVIATION 2.5 • n=4 Participants

PRIMARY outcome

Timeframe: one hour postoperatively

A Visual Analogue Scale was used. The scale range was 0 to 10 in increments of one. 0 was no pain and 10 was worst pain possible.

Outcome measures

Measure	Treatment TAP, Placebo Local Injection n=57 Participants Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site. ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally.	Placebo TAP, Treatment Local Injection n=58 Participants Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally.	Treatment TAP, Treatment Local Injection n=53 Participants Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally.
Postoperative Pain on a Visual Analogue Pain Scale at One Hour Postoperatively	4.04 units on a scale Standard Deviation 2.9	5.09 units on a scale Standard Deviation 2.46	4.4 units on a scale Standard Deviation 2.53

PRIMARY outcome

Timeframe: six hours postoperatively

Population: Arm 2: 6 hour pain score not obtained on one subject Arm 3: 6 hour pain score not obtained on one subject

A Visual Analogue Scale was used. The scale range was 0 to 10 in increments of one. 0 was no pain and 10 was worst pain possible.

Outcome measures

Measure	Treatment TAP, Placebo Local Injection n=57 Participants Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site. ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally.	Placebo TAP, Treatment Local Injection n=57 Participants Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally.	Treatment TAP, Treatment Local Injection n=52 Participants Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally.
Postoperative Pain on a Visual Analogue Pain Scale at Six Hours Postoperatively	3.53 units on a scale Standard Deviation 2.62	3.5 units on a scale Standard Deviation 1.93	3.33 units on a scale Standard Deviation 2.53

PRIMARY outcome

Timeframe: twenty-four hours postoperatively

Population: Arm 1: one subject discharged prior to obtaining 24 hour pain score Arm 2: one subject discharged prior to obtaining 24 hour pain score Arm 3: four subjects discharged prior to obtaining 24 hour pain score

A Visual Analogue Scale was used. The scale range was 0 to 10 in increments of one. 0 was no pain and 10 was worst pain possible.

Outcome measures

Measure	Treatment TAP, Placebo Local Injection n=56 Participants Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site. ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally.	Placebo TAP, Treatment Local Injection n=57 Participants Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally.	Treatment TAP, Treatment Local Injection n=49 Participants Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally.
Postoperative Pain on a Visual Analogue Pain Scale at Twenty-four Hours Postoperatively	3.36 units on a scale Standard Deviation 2.15	3.56 units on a scale Standard Deviation 2.13	3.51 units on a scale Standard Deviation 2.59

SECONDARY outcome

Timeframe: up to twenty-four hours postoperatively

Outcome measures

Measure	Treatment TAP, Placebo Local Injection n=57 Participants Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site. ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally.	Placebo TAP, Treatment Local Injection n=58 Participants Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally.	Treatment TAP, Treatment Local Injection n=53 Participants Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally.
Time Until First Request for Pain Medication	46 minutes Interval 18.0 to 104.0	31 minutes Interval 20.0 to 56.0	28 minutes Interval 13.0 to 78.0

SECONDARY outcome

Timeframe: up to twenty-four hours postoperatively

Outcome measures

Measure	Treatment TAP, Placebo Local Injection n=57 Participants Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site. ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally.	Placebo TAP, Treatment Local Injection n=58 Participants Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally.	Treatment TAP, Treatment Local Injection n=53 Participants Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally.
Total Narcotic Usage in Morphine Equivalents	20.09 mg Standard Deviation 11.6	23.14 mg Standard Deviation 12.3	20.68 mg Standard Deviation 12.8

Adverse Events

Treatment TAP, Placebo Local Injection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo TAP, Treatment Local Injection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment TAP, Treatment Local Injection

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. Eric Liberman

St. Barnabas Medical Center

Phone: 917-696-1370

Email: eliberma@montefiore.org

Results disclosure agreements

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