Transversus Abdominis Plane Block Versus Wound Infiltration for Postcesarean Analgesia

Mansoura University

Status: Completed

Conditions: Postcesarean Analgesia

Treatments: Drug: Intrathecal fentanyl; Drug: Intrathecal bupivacaine; Procedure: Transversus abdominis plane block; Procedure: Wound infiltration; Drug: Ketorolac; Procedure: Sham procedure; Drug: Paracetamol; Procedure: Spinal anesthesia; Procedure: Fentanyl patient-controlled analgesia; Procedure: Cesarean delivery

Study type: Interventional

Funder types: Other

Identifiers

NCT02691572

R/16.01.17

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 19 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. American Society of Anesthesiologists physical status II
2. Full-term singleton pregnancy

Exclusion criteria

1. Age <19 or > 40 years
2. Height <150 cm
3. Weight <60 kg
4. Body mass index ≥40 kg/m2
5. Contraindications to spinal anesthesia (patient refusal, increased intracranial tension, coagulopathy, uncorrected hypovolemia)
6. Hypersensitivity to any of the drugs used in the study
7. Significant cardiovascular, renal, or hepatic disease
8. Known fetal abnormalities
9. Emergency situations

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Wound Infiltration

Active Comparator group

Description:

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.

Treatment:

Drug: Ketorolac

Drug: Intrathecal bupivacaine

Drug: Paracetamol

Procedure: Spinal anesthesia

Procedure: Sham procedure

Drug: Intrathecal fentanyl

Procedure: Fentanyl patient-controlled analgesia

Procedure: Wound infiltration

Procedure: Cesarean delivery

Transversus abdominis plane block

Experimental group

Description:

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.

Treatment:

Drug: Ketorolac

Drug: Intrathecal bupivacaine

Drug: Paracetamol

Procedure: Transversus abdominis plane block

Procedure: Spinal anesthesia

Drug: Intrathecal fentanyl

Procedure: Fentanyl patient-controlled analgesia

Procedure: Cesarean delivery