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

Sponsor

Atlas University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05984160

Collaborator

(none)

Enrollment

Location

Arms

3.1

Anticipated Duration (Months)

29.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Post Operative Pain	Other: Paragastric neural block	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The patients were divided into two groups as perigastric neural block and control group.The patients were divided into two groups as perigastric neural block and control group.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes 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.

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 9, 2023

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 10, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Postoperative pain [In first 24 hours]
The investigators used visual analog scale. Minimum value 0 (means no pain), maximum values 10 (means worst pain ever).
Postoperative nause and vomiting [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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Atlas university	Istanbul		Turkey

Sponsors and Collaborators

Atlas University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Atlas University

ClinicalTrials.gov Identifier:

NCT05984160

Other Study ID Numbers:

E-22686390-050.99-27043

First Posted:

Aug 9, 2023

Last Update Posted:

Aug 9, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Atlas University

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Aug 9, 2023