Transversus Abdominis Plane Block Versus Wound Infiltration for Postcesarean Analgesia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison Between Transversus Abdominis Plane Block and Wound Infiltration for Analgesia After Cesarean Delivery

Conditions
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Postcesarean Analgesia

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists physical status II Full-term singleton pregnancy Exclusion Criteria: Age <19 or > 40 years Height <150 cm Weight <60 kg Body mass index ≥40 kg/m2 Contraindications to spinal anesthesia (patient refusal, increased intracranial tension, coagulopathy, uncorrected hypovolemia) Hypersensitivity to any of the drugs used in the study Significant cardiovascular, renal, or hepatic disease Known fetal abnormalities Emergency situations

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Wound Infiltration<br>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. | Procedure: Spinal anesthesia<br>* Performed at the L3-4 or L4-5 interspace using 27- or 25-gauge spinal needle.<br>Drug: Intrathecal bupivacaine<br>* Bupivacaine 12.5 mg will be administered in the subarachnoid space.<br>Drug: Intrathecal fentanyl<br>* Fentanyl 15 µg will be administered in the subarachnoid space.<br>Procedure: Cesarean delivery<br>* Lower segment cesarean section using the Pfannenstiel incision and exteriorization of the uterus.<br>Procedure: Wound infiltration<br>* 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.<br>Procedure: Sham procedure<br>* 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.<br>Drug: Ketorolac<br>* IV ketorolac 30 mg/8 h starting at the end of surgery.<br>Drug: Paracetamol<br>* Oral paracetamol 1 gm/8 h starting 4 h after surgery.<br>Procedure: Fentanyl patient-controlled analgesia<br>* Intravenous fentanyl: bolus dose = 20 µg, lockout interval = 7 min, 4-h dose limit = 200 µg, with no background infusion.<br>|
| Experimental: Transversus abdominis plane block<br>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. | Procedure: Spinal anesthesia<br>* Performed at the L3-4 or L4-5 interspace using 27- or 25-gauge spinal needle.<br>Drug: Intrathecal bupivacaine<br>* Bupivacaine 12.5 mg will be administered in the subarachnoid space.<br>Drug: Intrathecal fentanyl<br>* Fentanyl 15 µg will be administered in the subarachnoid space.<br>Procedure: Cesarean delivery<br>* Lower segment cesarean section using the Pfannenstiel incision and exteriorization of the uterus.<br>Procedure: Transversus abdominis plane block<br>* 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.<br>Drug: Ketorolac<br>* IV ketorolac 30 mg/8 h starting at the end of surgery.<br>Drug: Paracetamol<br>* Oral paracetamol 1 gm/8 h starting 4 h after surgery.<br>Procedure: Fentanyl patient-controlled analgesia<br>* Intravenous fentanyl: bolus dose = 20 µg, lockout interval = 7 min, 4-h dose limit = 200 µg, with no background infusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Fentanyl Dose |  | 24 h | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Fentanyl Dose |  | 2, 4, 6, 12 h | 
| Time to the First Postoperative Fentanyl Administration |  | 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. | 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. | 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). | 24 h | 
| Number of Patients With Pruritis | The occurrence of pruritis will be assessed by yes/no question and recorded. | 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). | 24 h |