Clinical trial NCT05984160: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Post Operative Pain
Keywords: Obesity
Post operative pain
Pain block
Sleeve gastrectomy
Lead sponsor: Atlas University
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients were divided into two groups as perigastric neural block and control group.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Postoperative pain
timeFrame: In first 24 hours
measure: Postoperative nause and vomiting
timeFrame: In first 24 hours
Secondary outcomes:
measure: First Rescue analgesia
timeFrame: In first 24 hours
measure: Second Rescue analgesia
timeFrame: In first 24 hours
measure: Rescue antiemetic
timeFrame: In first 24 hours
measure: Time to rescue antiemetic
timeFrame: In first 24 hours
measure: Time to first rescue analgesia
timeFrame: In first 24 hours
measure: Time to second rescue analgesia
timeFrame: In first 24 hours
measure: First mobilization time
timeFrame: In first 24 hours
measure: Operation time
timeFrame: Through operation completion, an avarage of 1 hour
measure: Patient satisfaction
timeFrame: In first 72 hours
measure: Pulse before block
timeFrame: at block moment
measure: Pulse 10 minutes after the block
timeFrame: 10 minutes after the block
measure: Sistolic blood pressure before the block
timeFrame: at block moment
measure: Sistolic blood pressure 10 minutes after the block
timeFrame: 10 minutes after the block
measure: Diastolic blood pressure before the block
timeFrame: at block moment
measure: Diastolic blood pressure 10 minutes after the block
timeFrame: 10 minutes after the block
measure: Complication at the block site
timeFrame: Through operation, an avarage of 1 hour
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Atlas university
Study officials:
affiliation: Atlas University
name: Mehmet K Katar, Assoc.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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