Efficacy of Paragastric Neural Block Procedure on Postoperative Pain in Patients Who Underwent Sleeve Gastrectomy

July 31, 2023 updated by: Atlas University

Efficacy and Safety of Paragastric Neural Block in Controlling Pain, Nausea and Vomiting After Laparoscopic Sleeve Gastrectomy; Prospective Randomized Controlled Double-blind Study

Surgical treatment is the most effective way to achieve effective and sustainable weight loss in patients with obesity and to improve the comorbidities caused by it.

Although minimally invasive bariatric surgical procedures are applied today, postoperative pain is one of the most basic problems. Opioid-derived drugs used for pain control cause respiratory depression and constipation. Enhanced Recovery After Surgery (ERAS) protocols recommend reducing opioid use after bariatric surgery to help patients have a healthier postoperative period.

Different methods such as transversus abdominis plane (TAP) block and erector spinae plane (ESP) block are used to reduce the postoperative opioid dose and for effective pain control. While these methods are effective in controlling somatic pain, they have no effect on visceral pain.

It has been shown that patients' pain and opioid consumption decrease especially after celiac plexus block. Vagal and sympathetic afferent stimuli from the gastrointestinal tract, on the other hand, stimulate the vomiting center and cause nausea and vomiting. Paragastric neural block is a new method performed by injecting local anesthetic into the posterosuperior paragastric area in the area covering the left gastric artery by revealing the esophagogastric junction, proximal stomach, middle of the stomach, distal antrum, hepatoduodenal ligament and stomach posterior along the border of the lesser omentum. In this way, it is aimed to prevent both visceral pain and the symptoms of nausea and vomiting.

In our study, the investigators aimed to evaluate the efficacy and safety of paragastric nerve block applied during laparoscopic sleeve gastrectomy by comparing it with the control group.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Atlas University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Body mass index of over 35 and an obesity-related comorbidity,
  • Body mass index of over 40,
  • Patients who underwent laparoscopic sleeve gastrectomy,
  • ASA risk score of 2-3,
  • Agreed to be included in the study.

Exclusion Criteria:

  • Chronic pain disorder or using gabapentin,
  • Opioid addicts,
  • Using anticoagulant drugs,
  • History of previous upper gastrointestinal system surgery,
  • Surgical complications during or after surgery,
  • Hepatic or renal failure,
  • Moderate or severe cardiovascular or respiratory disease,
  • Allergy to the local anesthetic agent to be applied for the block,
  • Limited cooperation,
  • More than one surgical intervention in the same session,
  • Allergy to the drugs to be used in the postoperative treatment protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Paragastric neural block
Patients who were operated for sleeve gastrectomy were included in the study. Afterwards, they were divided into two groups. While pragastric neural block was applied to one group, no intervention was made to the other group.
Other: Paragastric neural block
A block method used to control patients' symptoms of pain, nausea and vomiting after surgery.
No Intervention: Control
Control grup

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain
Time Frame: In first 24 hours
The investigators used visual analog scale. Minimum value 0 (means no pain), maximum values 10 (means worst pain ever).
In first 24 hours
Postoperative nause and vomiting
Time Frame: In first 24 hours
The investigators used Post operative nause and vomiting impact scale. Minimum value 0, maximum values 6. Total score >4 defines clinically important postoperative nause and vomiting.
In first 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First Rescue analgesia
Time Frame: In first 24 hours
Did patients need first rescue analgesia?
In first 24 hours
Second Rescue analgesia
Time Frame: In first 24 hours
Did patients need second rescue analgesia?
In first 24 hours
Rescue antiemetic
Time Frame: In first 24 hours
Did patients need rescue antiemetic drug?
In first 24 hours
Time to rescue antiemetic
Time Frame: In first 24 hours
When patients need rescue antiemetic drug?
In first 24 hours
Time to first rescue analgesia
Time Frame: In first 24 hours
When patients need first rescue analgesia?
In first 24 hours
Time to second rescue analgesia
Time Frame: In first 24 hours
when patients need second rescue analgesia?
In first 24 hours
First mobilization time
Time Frame: In first 24 hours
When patients start to walk?
In first 24 hours
Operation time
Time Frame: Through operation completion, an avarage of 1 hour
How long did the surgery take?
Through operation completion, an avarage of 1 hour
Patient satisfaction
Time Frame: In first 72 hours
The investigators used likert scale. Minimum value 1 (very unsatisfied), maximum values 5 (very satisfied).
In first 72 hours
Pulse before block
Time Frame: at block moment
Pulse before block
at block moment
Pulse 10 minutes after the block
Time Frame: 10 minutes after the block
Pulse 10 minutes after the block
10 minutes after the block
Sistolic blood pressure before the block
Time Frame: at block moment
Sistolic blood pressure before the block
at block moment
Sistolic blood pressure 10 minutes after the block
Time Frame: 10 minutes after the block
Sistolic blood pressure 10 minutes after the block
10 minutes after the block
Diastolic blood pressure before the block
Time Frame: at block moment
Diastolic blood pressure before the block
at block moment
Diastolic blood pressure 10 minutes after the block
Time Frame: 10 minutes after the block
Diastolic blood pressure 10 minutes after the block
10 minutes after the block
Complication at the block site
Time Frame: Through operation, an avarage of 1 hour
Were there any complications during the block?
Through operation, an avarage of 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atlas University

Investigators

  • Principal Investigator: Mehmet K Katar, Assoc.Prof., Atlas University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2023

Primary Completion (Estimated)

August 1, 2023

Study Completion (Estimated)

August 10, 2023

Study Registration Dates

First Submitted

July 18, 2023

First Submitted That Met QC Criteria

July 31, 2023

First Posted (Actual)

August 9, 2023

Study Record Updates

Last Update Posted (Actual)

August 9, 2023

Last Update Submitted That Met QC Criteria

July 31, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-22686390-050.99-27043

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared after the article is published.

IPD Sharing Time Frame

Start after the publication.

IPD Sharing Access Criteria

All results of working can be shared with researchers after the study is published.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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