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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Uncontrolled Postoperative Pain
• Intervention / Treatment: Drug: placebo; Drug: 0.375% ROPIVACAINE

Detailed Description

Introduction:

Cesarean sections are the most common surgical operations performed in the U.S (1). Patients requiring c-section who are on methadone maintenance often have uncontrolled pain due to opioid tolerance. The current treatment is to utilize large amounts of opioids via PCA thus resulting in a challenging situation with poor patient satisfaction.

The Transversus abdominis plane (TAP) block has been studied with success in many abdominal surgeries including c-sections (2-5). The anterior abdominal wall is innervated by anterior divisions of spinal segmental nerves which lie between the transversus abdominis and internal oblique muscle layers. Blockade of these nerves with local anesthetics may last up to 24 hours. There have been no efficacy studies performed using the TAP block in patients receiving chronic methadone maintenance undergoing c-sections.

Methods:

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.

Objective:

The primary objective of this study is to measure pain levels after c-sections in patients receiving methadone therapy utilizing visual analog scale (VAS) and assessing opioid consumption during the first 48 hours compared to placebo.

Conclusion:

It is hypothesized that patients receiving TAP block will have decreased pain intensity and less opioid consumption during the first two postoperative days compared to placebo. Therefore we believe postoperative TAP block to be an effective adjuvant to pain control for patients on methadone maintenance following c-section.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Laboring patients will only be enrolled in the study if they have a c-section performed. Inclusion criteria include patients who are 18-40 yr of age, ASA physical status I-III, 50-100 kg, 150 cm tall or greater, and English-speaking

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; saline injection	Drug: placebo
Experimental: Experimental; 0.375% ROPIVACAINE	Drug: 0.375% ROPIVACAINE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Investigators: Principal Investigator: Kishor Gandhi, MD, Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: July 17, 2012
• First Submitted That Met QC Criteria: July 18, 2012
• First Posted (Estimate): July 19, 2012

Study Record Updates

• Last Update Posted (Actual): May 8, 2017
• Last Update Submitted That Met QC Criteria: May 3, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 12D.37