NCT01261637

Brief Summary

This study has been designed to determine if women undergoing cesarean delivery with spinal anesthesia and routine pain management who also have an additional ultrasound guided transversus abdominis plane (TAP)block using ropivacaine have better pain relief and a better quality of recovery than women who don't have the additional TAP block. Maximizing pain relief using ultrasound guided TAP blocks in addition to neuraxial opioids, NSAIDs, and acetaminophen may improve acute pain outcomes, reduce adverse side effects, and potentially reduce chronic pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for phase_4 postoperative-pain

Timeline
Completed

Started Jul 2009

Typical duration for phase_4 postoperative-pain

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2010

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

May 23, 2013

Status Verified

May 1, 2013

Enrollment Period

1 year

First QC Date

December 15, 2010

Last Update Submit

May 22, 2013

Conditions

Postoperative Pain

Keywords

cesarean, pain, transversus abdominus plane block

Outcome Measures

Primary Outcomes (1)

  • The primary outcome will be postoperative pain, measured by an NRS, the quality of recovery score (QoR) and a Self Assessment Diary in the first 24h postoperative period.

    24 hours

Secondary Outcomes (3)

  • NRS / QoR - 48 hour Opioid Consumption Side effects - nausea, sedation

    48 hours

  • TAP block success rates and duration of block effect will be assessed using a patient diary completed every 2 hours while the patient is awake.

    24 hours

  • Persistant pain outcomes will be assessed at 30 days and 6 months using 5-minute SF-36 health survey.

    6 months

Study Arms (2)

0.25% Ropivicaine

EXPERIMENTAL

0.25% ropivicaine (maximum 1.5mg/kg)

Drug: Ropivicaine

Placebo

PLACEBO COMPARATOR

20ml saline

Drug: Saline placebo

Interventions

Saline placeboDRUG

20ml saline

Placebo
RopivicaineDRUG

0.25% ropivicaine (maximum 1.5mg/kg)

Also known as: Naropin
0.25% Ropivicaine

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-emergent CD with planned spinal anesthesia
  • American Society of Anesthesia physical status class I \& II
  • Age ≥ 18 years
  • Term gestational age (≥ 37 weeks)
  • English-speaking

You may not qualify if:

  • Morbid Obesity (BMI³ 45 kg/m2)
  • Laboring women
  • Emergency CD
  • Severe maternal cardiac disease
  • Subjects with significant obstetric co-morbidities
  • Failed spinal anesthesia
  • Patient enrollment in another study involving medication within 30 days of CD
  • Any other condition which may impair ability to cooperate with data collection
  • Height less than 152 cm (5'0")
  • Fetal anomalies or intrauterine fetal death

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, Canada

Location

Related Publications (1)

  • McKeen DM, George RB, Boyd JC, Allen VM, Pink A. Transversus abdominis plane block does not improve early or late pain outcomes after Cesarean delivery: a randomized controlled trial. Can J Anaesth. 2014 Jul;61(7):631-40. doi: 10.1007/s12630-014-0162-5. Epub 2014 Apr 24.

    PMID: 24764186DERIVED

MeSH Terms

Conditions

Pain, PostoperativePain

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Dolores McKeen, MD MSc FRCPC

    IWK Health Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator, MD, FRCPC, Assistant Professor

Study Record Dates

First Submitted

December 15, 2010

First Posted

December 16, 2010

Study Start

July 1, 2009

Primary Completion

July 1, 2010

Study Completion

January 1, 2011

Last Updated

May 23, 2013

Record last verified: 2013-05

Locations

CA(1)