Clinical trial NCT02691572
Conditions: Postcesarean Analgesia
Sponsor: Mansoura University
Start date: 2016-02-01; Completion date: 2016-05-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will compare the analgesic efficacy of transversus abdominis plane block and wound infiltration in parturients undergoing cesarean delivery under spinal anesthesia.

Detailed description:
This randomized, controlled, double-blind study will be conducted on ASA physical status II parturients with full-term singleton pregnancy undergoing elective cesarean delivery under spinal anesthesia. Patients will receive either ultrasound-guided transversus abdominis plane block or wound infiltration at the end of surgery. After delivery, all patients will receive standard analgesia (intravenous ketorolac and oral paracetamol) and patient-controlled analgesia with intravenous fentanyl. Total fentanyl consumption at 24 h, pain scores at 2, 4, 6, 12, and 24 h, side effects, and patient satisfaction will be compared between the 2 groups.

Arms: arm 1: 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% will be injected subcutaneously in the surgical wound (15 mL on the upper and lower sides) by the obstetrician before skin suturing. Sham procedure will be performed after surgery. Standard analgesia (ketorolac and paracetamol) and fentanyl patient-controlled analgesia will be administered postoperatively. arm 2: 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 will be performed using 20 mL bupivacaine 0.25% on each side. Standard analgesia (ketorolac and paracetamol) and fentanyl patient-controlled analgesia will be administered postoperatively.
Interventions: intervention 1: Spinal anesthesia intervention 2: Intrathecal bupivacaine intervention 3: Intrathecal fentanyl intervention 4: Cesarean delivery intervention 5: Wound infiltration intervention 6: Sham procedure intervention 7: Transversus abdominis plane block intervention 8: Ketorolac intervention 9: Paracetamol intervention 10: Fentanyl patient-controlled analgesia
Intervention descriptions: intervention 1: Performed at the L3-4 or L4-5 interspace using 27- or 25-gauge spinal needle. intervention 2: Bupivacaine 12.5 mg will be administered in the subarachnoid space. intervention 3: Fentanyl 15 µg will be administered in the subarachnoid space. intervention 4: Lower segment cesarean section using the Pfannenstiel incision and exteriorization of the uterus. intervention 5: 30 mL bupivacaine 0.25% will be injected subcutaneously in the surgical wound (15 mL on the upper and lower sides) by the obstetrician before skin suturing. intervention 6: Sham procedure will be performed after surgery by moving the ultrasound probe and pressing a covered spinal needle on both sides of the patients' abdomen. intervention 7: Bilateral ultrasound-guided TAP block using 20 mL bupivacaine 0.25% on each side. A 7-12 MHz linear array probe and 22-gauge needle will be used. The probe will be placed transversely above the iliac crest in the anterior axillary line and the needle will be introduced in-plane with the probe from medial to lateral. intervention 8: IV ketorolac 30 mg/8 h starting at the end of surgery. intervention 9: Oral paracetamol 1 gm/8 h starting 4 h after surgery. intervention 10: Intravenous fentanyl: bolus dose = 20 µg, lockout interval = 7 min, 4-h dose limit = 200 µg, with no background infusion.

Protocol documents: