Efficacy of Paragastric Neural Block Procedure on Postoperative Pain in Patients Who Underwent Sleeve Gastrectomy
- Conditions
- Post Operative PainObesity
- Interventions
- Other: Paragastric neural block
- Registration Number
- NCT05984160
- Lead Sponsor
- Atlas University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 90
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Paragastric neural block 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Pulse before block at block moment Pulse before block
Time to rescue antiemetic In first 24 hours When patients need rescue antiemetic drug?
First Rescue analgesia In first 24 hours Did patients need first rescue analgesia?
Pulse 10 minutes after the block 10 minutes after the block Pulse 10 minutes after 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
Complication at the block site Through operation, an avarage of 1 hour Were there any complications during the block?
Time to second rescue analgesia In first 24 hours when patients need second rescue analgesia?
Operation time Through operation completion, an avarage of 1 hour How long did the surgery take?
Sistolic blood pressure before the block at block moment Sistolic 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
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?
Patient satisfaction In first 72 hours The investigators used likert scale. Minimum value 1 (very unsatisfied), maximum values 5 (very satisfied).
Time to first rescue analgesia In first 24 hours When patients need first rescue analgesia?
First mobilization time In first 24 hours When patients start to walk?
Trial Locations
- Locations (1)
Atlas university
🇹🇷Istanbul, Turkey