NCT01644864

Brief Summary

This is a prospective randomized double-blind placebo controlled study (0.375% Ropivacaine vs. 0.9% saline) designed to evaluate the effectiveness of transverse abdominis plane (TAP) block in the first 48 hours after c-section in patients receiving methadone therapy. The TAP block will be performed by a regional anesthesiologist in the operating room after delivery of the baby.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Study Start

First participant enrolled

July 1, 2012

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

May 8, 2017

Status Verified

May 1, 2017

Enrollment Period

1.3 years

First QC Date

July 17, 2012

Last Update Submit

May 3, 2017

Conditions

Uncontrolled Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Quality of Recovery after TAP block

    The primary objective of this study is to measure pain levels after c-sections in patients on methadone maintenance therapy for opioid abstinence. Our objectives are to evaluate the onset and extent of the sensory block following TAP block with 40 mL 0.375% ropivacaine injection compared to placebo block. The degree of sensory block will determine quality of pain scores and degree of opioid consumption. The secondary objective is to administer a previously validated quality of recovery scale (QoR-40) on post-operative days 1 \& 2 (POD 1 \& 2).

    48 hours

Study Arms (2)

Placebo

PLACEBO COMPARATOR

saline injection

Drug: placebo

Experimental

EXPERIMENTAL

0.375% ROPIVACAINE

Drug: 0.375% ROPIVACAINE

Interventions

0.375% ROPIVACAINEDRUG
Experimental
placeboDRUG
Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • Patient refusal, methadone use for chronic pain, contraindications to administration of regional anesthesia (e.g., allergy to a local anesthetic, local infection and coagulopathy), significant neurologic disorders of the lower extremity, and psychiatric or cognitive disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Kishor Gandhi, MD

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2012

First Posted

July 19, 2012

Study Start

July 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

May 8, 2017

Record last verified: 2017-05

Locations

US(1)