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

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity, Post Operative Pain

Intervention / Treatment
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* Other: Paragastric neural block


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The patients were divided into two groups as perigastric neural block and control group.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paragastric neural block<br>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<br>* A block method used to control patients' symptoms of pain, nausea and vomiting after surgery.<br>|
| No Intervention: Control<br>Control grup | |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Post operative pain, Pain block, Sleeve gastrectomy