drugset / Trial / NCT03236324

Transversalis Fascia Plane Blocks for Analgesia Post-cesarean Delivery

NCT03236324

Phase 2 Completed 106 enrolled University of Calgary
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupivacaine Other / unclassified 0.25 % Other
Subject Bupivacaine Other / unclassified 2.5 mg/kg Other
Background Epinephrine Other / unclassified 2.5 ug/ml Other

Indications

No indication recorded.