The study will compare the analgesic efficacy of transversus abdominis plane block and wound infiltration in parturients undergoing cesarean delivery under spinal anesthesia.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
Performed at the L3-4 or L4-5 interspace using 27- or 25-gauge spinal needle.
Bupivacaine 12.5 mg will be administered in the subarachnoid space.
Fentanyl 15 µg will be administered in the subarachnoid space.
Department of Anesthesia, Mansoura University Hospitals
Al Mansurah, Dakahlia Governorate, Egypt
Cumulative Fentanyl Dose
Time frame: 24 h
Cumulative Fentanyl Dose
Time frame: 2, 4, 6, 12 h
Time to the First Postoperative Fentanyl Administration
Time frame: 24 h
Pain Scores at Rest and Movement
Assessed using 11-point verbal rating scale (0 = no pain, 10 = the worst possible pain), at rest and movement.
Time frame: 2, 4, 6, 12, and 24 h
Number of Patients With Nausea and/or Vomiting
The occurrence of nausea and/or vomiting will be observed and recorded.
Time frame: 24 h
Level of Sedation
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).
Time frame: 24 h
Number of Patients With Pruritis
The occurrence of pruritis will be assessed by yes/no question and recorded.
Time frame: 24 h
Level of Patient Satisfaction
Assessed at 24 h using a 5-point scale (1 = very unsatisfied, 2 = unsatisfied, 3 = fair, 4 = satisfied, 5 = very satisfied).
Time frame: 24 h
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Lower segment cesarean section using the Pfannenstiel incision and exteriorization of the uterus.
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 by moving the ultrasound probe and pressing a covered spinal needle on both sides of the patients' abdomen.
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.
IV ketorolac 30 mg/8 h starting at the end of surgery.
Oral paracetamol 1 gm/8 h starting 4 h after surgery.
Intravenous fentanyl: bolus dose = 20 µg, lockout interval = 7 min, 4-h dose limit = 200 µg, with no background infusion.