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Transversalis Fascia Plane Blocks for Analgesia Post-cesarean Delivery

NCT03236324 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2023-05-10

No results posted yet for this study

Summary

The aim of this study is to assess the efficacy of a bilateral TFP block in parturients undergoing cesarean delivery (CD) by evaluating postoperative opioid consumption and numeric rated pain scores in two groups (TFP block with saline (control) and TFP block with local anesthetic (treatment)). Women (American Society of Anesthesiologists physical status Class 1-3) at term gestation with singleton pregnancies undergoing an elective CD under spinal anesthesia at the South Health Campus will be consented to participate in the study. Patients will be randomly assigned using a computer-generated table of random numbers to two groups. Group allocations will be concealed. All patients will receive spinal anesthesia with spinal Morphine according to our institutional protocol. At the end of surgery, randomized patients will receive either ultrasound-guided bilateral TFP blocks with 0.25% bupivacaine with 2.5 mcg/ml epinephrine 40 ml total or maximum 2.5 mg/kg (Group 1) or 40 mL saline (Group 2) by 2 anesthesiologists experienced in performing this block.

Conditions

  • Cesarean Delivery

Interventions

DEVICE

ultrasound-guided nerve block

Transversalis fascia plane (TFP) block, ultrasound-guided

DRUG

Saline

20 mL 0.9% saline administered on each side as bilateral TFP blocks

DRUG

Bupivacaine-epinephrine

20 mL bupivacaine 0.25% with epinephrine 2.5 mcg/mL to a maximum of 2.5mg/kg administered on each side as bilateral TFP blocks

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-22
Primary Completion
2022-10-13
Completion
2022-12-11

Countries

  • Canada

Study Locations

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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 NCT03236324 on ClinicalTrials.gov