Trials Sponsors Conditions Drugs Pricing

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

Thomas Jefferson University
Otherlead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

Kishor Gandhi, MD
Thomas Jefferson University
PRINCIPAL INVESTIGATOR

Enrollment

0 participants (actual enrollment reported by the registry).

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 2012

Date type not reported

This date has not been verified as actual or estimated.

Study Stopped

Can Post-operative TAP Block Improve Quality of Recovery After C-sections in Patients on Methadone Maintenance?

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Placebo

Experimental

Interventions

Eligibility Criteria

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Placebo

Experimental

Interventions

Eligibility Criteria

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations