Trial Outcomes & Findings for Transversus Abdominis Plane Block Versus Wound Infiltration for Postcesarean Analgesia (NCT NCT02691572)

NCT ID: NCT02691572

Last Updated: 2018-10-31

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 80 participants
• Primary outcome timeframe: 24 h
• Results posted on: 2018-10-31

Participant Flow

Participant milestones

Measure	Wound Infiltration Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). At the end of surgery, 30 mL bupivacaine 0.25% was injected subcutaneously in the surgical wound (15 mL on the upper and lower sides) by the obstetrician before skin suturing. Sham procedure was performed after surgery. Standard analgesia (ketorolac and paracetamol) and fentanyl patient-controlled analgesia were administered postoperatively	Transversus Abdominis Plane Block Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). After completion of surgery, bilateral ultrasound-guided TAP block was performed using 20 mL bupivacaine 0.25% on each side. Standard analgesia (ketorolac and paracetamol) and fentanyl patient-controlled analgesia were administered postoperatively
Overall Study STARTED	40	40
Overall Study COMPLETED	39	39
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Wound Infiltration Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). At the end of surgery, 30 mL bupivacaine 0.25% was injected subcutaneously in the surgical wound (15 mL on the upper and lower sides) by the obstetrician before skin suturing. Sham procedure was performed after surgery. Standard analgesia (ketorolac and paracetamol) and fentanyl patient-controlled analgesia were administered postoperatively	Transversus Abdominis Plane Block Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). After completion of surgery, bilateral ultrasound-guided TAP block was performed using 20 mL bupivacaine 0.25% on each side. Standard analgesia (ketorolac and paracetamol) and fentanyl patient-controlled analgesia were administered postoperatively
Overall Study Withdrawal by Subject	1	0
Overall Study Protocol Violation	0	1

Baseline Characteristics

Transversus Abdominis Plane Block Versus Wound Infiltration for Postcesarean Analgesia

Baseline characteristics by cohort

Measure	Wound Infiltration n=39 Participants Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). At the end of surgery, 30 mL bupivacaine 0.25% was injected subcutaneously in the surgical wound (15 mL on the upper and lower sides) by the obstetrician before skin suturing. Sham procedure was performed after surgery. Standard analgesia (ketorolac and paracetamol) and fentanyl patient-controlled analgesia were administered postoperatively	Transversus Abdominis Plane Block n=39 Participants Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). After completion of surgery, bilateral ultrasound-guided TAP block was performed using 20 mL bupivacaine 0.25% on each side. Standard analgesia (ketorolac and paracetamol) and fentanyl patient-controlled analgesia were administered postoperatively	Total n=78 Participants Total of all reporting groups
Age, Continuous	26.2 years STANDARD_DEVIATION 4.4 • n=5 Participants	26.7 years STANDARD_DEVIATION 4.1 • n=7 Participants	26.4 years STANDARD_DEVIATION 4.2 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	39 Participants n=7 Participants	78 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Height	163 cm STANDARD_DEVIATION 6 • n=5 Participants	162 cm STANDARD_DEVIATION 4 • n=7 Participants	163 cm STANDARD_DEVIATION 5 • n=5 Participants
Weight	86 kg STANDARD_DEVIATION 13 • n=5 Participants	81.8 kg STANDARD_DEVIATION 9.2 • n=7 Participants	83.9 kg STANDARD_DEVIATION 11.4 • n=5 Participants
Body mass index	32.3 kg/m^2 STANDARD_DEVIATION 3.7 • n=5 Participants	31 kg/m^2 STANDARD_DEVIATION 3.3 • n=7 Participants	31.7 kg/m^2 STANDARD_DEVIATION 3.6 • n=5 Participants
Gestational age	38 weeks n=5 Participants	38 weeks n=7 Participants	38 weeks n=5 Participants
Nulliparous	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 h

Outcome measures

Measure	Wound Infiltration n=39 Participants Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). At the end of surgery, 30 mL bupivacaine 0.25% was injected subcutaneously in the surgical wound (15 mL on the upper and lower sides) by the obstetrician before skin suturing. Sham procedure was performed after surgery. Standard analgesia (ketorolac and paracetamol) and fentanyl patient-controlled analgesia were administered postoperatively	Transversus Abdominis Plane Block n=39 Participants Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 µg). After completion of surgery, bilateral ultrasound-guided TAP block was performed using 20 mL bupivacaine 0.25% on each side. Standard analgesia (ketorolac and paracetamol) and fentanyl patient-controlled analgesia were administered postoperatively
Cumulative Fentanyl Dose	157.4 mcg Standard Deviation 63.4	153.3 mcg Standard Deviation 68.3

SECONDARY outcome

Timeframe: 2, 4, 6, 12 h

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 h

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2, 4, 6, 12, and 24 h

Assessed using 11-point verbal rating scale (0 = no pain, 10 = the worst possible pain), at rest and movement.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 h

The occurrence of nausea and/or vomiting will be observed and recorded.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 h

Assessed using a 4-point scale (1 = awake and alert, 2 = minimally sedated, responds to speech, 3 = moderately sedated, rousable by tactile stimulation, 4 = deeply sedated, rousable only with painful stimulation).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 h

The occurrence of pruritis will be assessed by yes/no question and recorded.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 h

Assessed at 24 h using a 5-point scale (1 = very unsatisfied, 2 = unsatisfied, 3 = fair, 4 = satisfied, 5 = very satisfied).

Outcome measures

Outcome data not reported

Adverse Events

Wound Infiltration

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Transversus Abdominis Plane 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. Mohamed Mohamed Tawfik

Department of Anesthesia and Surgical Intensive Care, Mansoura University Hospitals, Mansoura, Egypt.

Phone: 1001183400

Email: m2tawfik@mans.edu.eg

Results disclosure agreements

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