The Feasibility of Performing Erector Spinae (ESP) Nerve Block in Bariatric Patients; a Case Series Study
Primary Purpose
Nerve Pain
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ultrasound Guided Erector Spinae Plane (ESP) Nerve Block
Bupivacaine Injection
Sponsored by
About this trial
This is an interventional treatment trial for Nerve Pain
Eligibility Criteria
Inclusion Criteria:
- Age range 21 - 70.
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
ESP nerve block
Standard of Care
Arm Description
Standard of care includes IV opioids, NSAIDs (commonly ketorolac), +/- acetaminophen. No regional anesthesia will be given to control patients.
Outcomes
Primary Outcome Measures
Rate of reduction of opiod usage after ESP Block
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 Outcome Measures
Number of patients who experience an adverse events
Pain scores (self reported) assessed by the NRS rating scale
Pain scores will be collected every 30 mins in the PACU and at 24 and 48 hours during the hospital stay. NRS pain scale=0 no pain to 10 Worst pain imaginable
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04477525
Brief Title
The Feasibility of Performing Erector Spinae (ESP) Nerve Block in Bariatric Patients; a Case Series Study
Official Title
The Feasibility of Performing Erector Spinae (ESP) Nerve Block in Bariatric Patients; a Case Series Stud
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Withdrawn
Why Stopped
PI changed hospital center
Study Start Date
June 22, 2021 (Anticipated)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nerve Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ESP nerve block
Arm Type
Experimental
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Standard of care includes IV opioids, NSAIDs (commonly ketorolac), +/- acetaminophen. No regional anesthesia will be given to control patients.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound Guided Erector Spinae Plane (ESP) Nerve Block
Intervention Description
The planned intervention is a bilateral erector spinae nerve block for patients undergoing bariatric surgery. This intervention will be performed in the PACU for patients with an NRS pain score >5. All eligible candidates who have consented for this study will be present in the PACU, have all standard ASA monitoring placed. The patient will then be placed in a sitting position. The patient will then be prepped with chlorhexidine in the thoracic region and draped in a sterile fashion. The ultrasound will be brought in over the patient and the T7 Transverse Processes (TP) will be identified. An echogenic needle will be placed under direct ultrasound guidance on the TP. Then, 20 cc of 0.25% bupivacaine will be injected.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Injection
Intervention Description
20 cc of 0.25% bupivacaine will be injected
Primary Outcome Measure Information:
Title
Rate of reduction of opiod usage after ESP Block
Description
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.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Number of patients who experience an adverse events
Time Frame
Up to 3 days
Title
Pain scores (self reported) assessed by the NRS rating scale
Description
Pain scores will be collected every 30 mins in the PACU and at 24 and 48 hours during the hospital stay. NRS pain scale=0 no pain to 10 Worst pain imaginable
Time Frame
Every 30 min while in the post-anesthesia care unit (PACU); at 24 and 48 hours during hospital stay
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age range 21 - 70.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farah Fadi
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Feasibility of Performing Erector Spinae (ESP) Nerve Block in Bariatric Patients; a Case Series Study
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