Transversus Abdominis Plane Block Versus Wound Infiltration for Postcesarean Analgesia

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

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

Study Overview

• Status: Completed
• Conditions: Postcesarean Analgesia
• Intervention / Treatment: Procedure: Spinal anesthesia; Drug: Intrathecal bupivacaine; Drug: Intrathecal fentanyl; Procedure: Cesarean delivery; Procedure: Wound infiltration; Procedure: Sham procedure; Drug: Ketorolac; Drug: Paracetamol; Procedure: Fentanyl patient-controlled analgesia; Procedure: Transversus abdominis plane block

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 35511
      • Department of Anesthesia, Mansoura University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: February 16, 2016
• First Submitted That Met QC Criteria: February 20, 2016
• First Posted (Estimate): February 25, 2016

Study Record Updates

• Last Update Posted (Actual): October 31, 2018
• Last Update Submitted That Met QC Criteria: March 30, 2018
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Ketorolac; Acetaminophen; Bupivacaine
• Other Study ID Numbers: R/16.01.17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO