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

Uncontrolled Postoperative Pain Clinical Trial

— TAP  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01644864
• Other study ID #: 12D.37
• Status: Withdrawn
• Phase: Phase 4
• First received: July 17, 2012
• Last updated: May 3, 2017
• Start date: July 2012
• Est. completion date: November 2013

Study information

• Verified date: May 2017
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Uncontrolled Postoperative Pain

Intervention

Drug:
• 0.375% ROPIVACAINE

• placebo

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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