Transversus Abdominis Plane Block Versus Wound Infiltration for Postcesarean Analgesia

NCT02691572 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-10-31

Study results available
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Summary

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

Conditions

  • Postcesarean Analgesia

Interventions

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.

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.

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.

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Mohamed M Tawfik, MD · Mansoura University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • Egypt

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02691572 on ClinicalTrials.gov