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Clinical Trials/NCT04477525
NCT04477525
Withdrawn
Phase 2

The Feasibility of Performing Erector Spinae (ESP) Nerve Block in Bariatric Patients; a Case Series Stud

Montefiore Medical Center0 sitesJune 22, 2021

Overview

Phase
Phase 2
Intervention
Ultrasound Guided Erector Spinae Plane (ESP) Nerve Block
Conditions
Nerve Pain
Sponsor
Montefiore Medical Center
Primary Endpoint
Rate of reduction of opiod usage after ESP Block
Status
Withdrawn
Last Updated
4 years ago

Overview

Brief Summary

This study is a pilot study to assess the effectiveness of erector spinae (ESP) nerve blocks for postoperative pain control following bariatric surgery. Currently, there are mainly case series/pilot studies describing the use of ESP nerve blocks for postoperative pain control in abdominal procedures; of these only one uses this treatment modality for bariatric procedures. The population undergoing bariatric surgery poses specific challenges to postoperative pain management. They often have comorbid obstructive sleep apnea, which puts them at greater risk for ventilatory depression when treated with parenteral opioids. This risk can be reduced with regional techniques. The ESP nerve blocks provide visceral and somatic pain coverage as opposed to the more commonplace transversus abdominis plane nerve block which only provides somatic coverage. This means that the ESP nerve blocks will cover incisional pain as well as the discomfort associated with the pain from the procedure itself. This study intends to build on current knowledge by proving that the use of ESP in the post-operative are providing a significant reduction in pain scores as well as reducing the need for parenteral opioids. Thus, decreasing the risk of postoperative ventilatory complications.

In preparation for this study, three pilot studies were reviewed. The studies assessed the usefulness of ESP nerve blocks on patients undergoing abdominal surgery. Single-shot bilateral ESP blocks were performed in the first two studies. One of the studies, patients undergoing ventral hernia repair and the other for patients undergoing bariatric surgery. The third pilot study used bilateral ESP blocks followed by a continuous infusion on one patient undergoing an open prostatectomy with bladder reconstruction. All the ESP blocks were placed preoperatively at the T7 transverse process. In the studies using a single shot technique 20-30 ml of ropivacaine 0.5% was used. For the continuous ESP catheter an initial bolus of bupivacaine 0.25% 10 mls followed by continuous infusion rate of 6 ml/hr bilaterally. All showed a significant reduction numerical rating scale (NRS) as a primary outcome. The secondary outcome of reduced 24-hour parenteral opioid consumption was also achieved by all three studies.

Registry
clinicaltrials.gov
Start Date
June 22, 2021
End Date
June 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age range 21 -
  • ASA II: A patient with mild systemic disease-ASA III: A patient with severe systemic disease
  • Patients included are those immediately postoperative from bariatric surgery who have an NSR pain score \>5

Exclusion Criteria

  • Patients excluded are those who are ASA IV or greater, refuse nerve block intervention,
  • Diagnosis of any coagulopathy disorder,
  • Allergy to local anesthetics,
  • Have active infection over proposed injection sites.
  • Patients with ASA \>III was excluded due to overall health concerns of poorly controlled chronic disease.

Arms & Interventions

ESP nerve block

Intervention: Ultrasound Guided Erector Spinae Plane (ESP) Nerve Block

ESP nerve block

Intervention: Bupivacaine Injection

Outcomes

Primary Outcomes

Rate of reduction of opiod usage after ESP Block

Time Frame: 24 hours

This study will evaluate the role of ESP blocks in reducing 24-hour opioid requirements after bariatric surgery, specifically looking into 30% or more reduction in opioid usage ( morphine equivalence) in the 24 hours.

Secondary Outcomes

  • Pain scores (self reported) assessed by the NRS rating scale(Every 30 min while in the post-anesthesia care unit (PACU); at 24 and 48 hours during hospital stay)
  • Number of patients who experience an adverse events(Up to 3 days)

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