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

Primary Purpose

Obesity, Post Operative Pain

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Paragastric neural block
Sponsored by
Atlas University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Post operative pain, Pain block, Sleeve gastrectomy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Atlas university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Paragastric neural block

Control

Arm Description

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.

Control grup

Outcomes

Primary Outcome Measures

Postoperative pain
The investigators used visual analog scale. Minimum value 0 (means no pain), maximum values 10 (means worst pain ever).
Postoperative nause and vomiting
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.

Secondary Outcome Measures

First Rescue analgesia
Did patients need first rescue analgesia?
Second Rescue analgesia
Did patients need second rescue analgesia?
Rescue antiemetic
Did patients need rescue antiemetic drug?
Time to rescue antiemetic
When patients need rescue antiemetic drug?
Time to first rescue analgesia
When patients need first rescue analgesia?
Time to second rescue analgesia
when patients need second rescue analgesia?
First mobilization time
When patients start to walk?
Operation time
How long did the surgery take?
Patient satisfaction
The investigators used likert scale. Minimum value 1 (very unsatisfied), maximum values 5 (very satisfied).
Pulse before block
Pulse before block
Pulse 10 minutes after the block
Pulse 10 minutes after the block
Sistolic blood pressure before the block
Sistolic blood pressure before the block
Sistolic blood pressure 10 minutes after the block
Sistolic blood pressure 10 minutes after the block
Diastolic blood pressure before the block
Diastolic blood pressure before the block
Diastolic blood pressure 10 minutes after the block
Diastolic blood pressure 10 minutes after the block
Complication at the block site
Were there any complications during the block?

Full Information

First Posted
July 18, 2023
Last Updated
July 31, 2023
Sponsor
Atlas University
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1. Study Identification

Unique Protocol Identification Number
NCT05984160
Brief Title
Efficacy of Paragastric Neural Block Procedure on Postoperative Pain in Patients Who Underwent Sleeve Gastrectomy
Official Title
Efficacy and Safety of Paragastric Neural Block in Controlling Pain, Nausea and Vomiting After Laparoscopic Sleeve Gastrectomy; Prospective Randomized Controlled Double-blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 9, 2023 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
August 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Atlas University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Post Operative Pain
Keywords
Obesity, Post operative pain, Pain block, Sleeve gastrectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The patients were divided into two groups as perigastric neural block and control group.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Randomization was performed by a general surgeon who would not be present during the block procedure. Patients were numbered sequentially according to the randomization scheme. Patient numbers were recorded in the follow-up files. Evaluation of the postoperative results was done by a general surgeon who was unaware of the group distributions. Since both the patients and the general surgeon who will make the evaluation did not know whether the block procedure was applied or not, the study was performed as double-blind.
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paragastric neural block
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control grup
Intervention Type
Other
Intervention Name(s)
Paragastric neural block
Intervention Description
A block method used to control patients' symptoms of pain, nausea and vomiting after surgery.
Primary Outcome Measure Information:
Title
Postoperative pain
Description
The investigators used visual analog scale. Minimum value 0 (means no pain), maximum values 10 (means worst pain ever).
Time Frame
In first 24 hours
Title
Postoperative nause and vomiting
Description
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.
Time Frame
In first 24 hours
Secondary Outcome Measure Information:
Title
First Rescue analgesia
Description
Did patients need first rescue analgesia?
Time Frame
In first 24 hours
Title
Second Rescue analgesia
Description
Did patients need second rescue analgesia?
Time Frame
In first 24 hours
Title
Rescue antiemetic
Description
Did patients need rescue antiemetic drug?
Time Frame
In first 24 hours
Title
Time to rescue antiemetic
Description
When patients need rescue antiemetic drug?
Time Frame
In first 24 hours
Title
Time to first rescue analgesia
Description
When patients need first rescue analgesia?
Time Frame
In first 24 hours
Title
Time to second rescue analgesia
Description
when patients need second rescue analgesia?
Time Frame
In first 24 hours
Title
First mobilization time
Description
When patients start to walk?
Time Frame
In first 24 hours
Title
Operation time
Description
How long did the surgery take?
Time Frame
Through operation completion, an avarage of 1 hour
Title
Patient satisfaction
Description
The investigators used likert scale. Minimum value 1 (very unsatisfied), maximum values 5 (very satisfied).
Time Frame
In first 72 hours
Title
Pulse before block
Description
Pulse before block
Time Frame
at block moment
Title
Pulse 10 minutes after the block
Description
Pulse 10 minutes after the block
Time Frame
10 minutes after the block
Title
Sistolic blood pressure before the block
Description
Sistolic blood pressure before the block
Time Frame
at block moment
Title
Sistolic blood pressure 10 minutes after the block
Description
Sistolic blood pressure 10 minutes after the block
Time Frame
10 minutes after the block
Title
Diastolic blood pressure before the block
Description
Diastolic blood pressure before the block
Time Frame
at block moment
Title
Diastolic blood pressure 10 minutes after the block
Description
Diastolic blood pressure 10 minutes after the block
Time Frame
10 minutes after the block
Title
Complication at the block site
Description
Were there any complications during the block?
Time Frame
Through operation, an avarage of 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet K Katar, Assoc.Prof.
Organizational Affiliation
Atlas University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atlas university
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
12513041
Citation
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Citation
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Efficacy of Paragastric Neural Block Procedure on Postoperative Pain in Patients Who Underwent Sleeve Gastrectomy

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