NCT03236324

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2017

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 1, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

September 22, 2017

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2022

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

5.1 years

First QC Date

July 25, 2017

Last Update Submit

May 9, 2023

Conditions

Cesarean Delivery

Outcome Measures

Primary Outcomes (1)

  • Postoperative opioid consumption

    24-hour postoperative opioid consumption presented in morphine equivalents

    24 hours

Secondary Outcomes (6)

  • Numeric rating scale pain scores

    up to 48 hours

  • Time to first analgesia

    48 hours

  • Opioid side effects

    48 hours

  • Patient satisfaction

    48 hours

  • Quality of recovery scores

    up to 48 hours

  • +1 more secondary outcomes

Study Arms (2)

TFP block with saline

PLACEBO COMPARATOR

Placebo bilateral ultrasound-guided nerve block \[transversalis fascia plane (TFP) block\] with 40 mL saline, single shot

Device: ultrasound-guided nerve blockDrug: Saline

TFP block with local anesthetic

EXPERIMENTAL

Experimental bilateral ultrasound-guided nerve block \[transversalis fascia plane (TFP) block\] with local anesthesic of Bupivacaine-epinephrine \[0.25% bupivacaine with 2.5 mcg/mL epinephrine 40 mL (maximum 2.5 mg/kg)\], single shot

Device: ultrasound-guided nerve blockDrug: Bupivacaine-epinephrine

Interventions

ultrasound-guided nerve blockDEVICE

Transversalis fascia plane (TFP) block, ultrasound-guided

TFP block with local anestheticTFP block with saline
SalineDRUG

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

TFP block with saline
Bupivacaine-epinephrineDRUG

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

TFP block with local anesthetic

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • elective Cesarean delivery with spinal anesthesia at South Health Campus
  • term gestation with a singleton pregnancy
  • American Society of Anesthesiologists' (ASA) physical status Class 1-3

You may not qualify if:

  • language barrier
  • body mass index (BMI) \> 40 kg/m2
  • multiple gestations
  • chronic pain
  • opioid use
  • substance abuse
  • allergies to study medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Health Campus

Calgary, Alberta, T3M 1M4, Canada

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2017

First Posted

August 1, 2017

Study Start

September 22, 2017

Primary Completion

October 13, 2022

Study Completion

December 11, 2022

Last Updated

May 10, 2023

Record last verified: 2023-05

Locations

CA(1)