Intraperitoneal Versus Intravenous Dexmedetomidine for Post-operative Analgesia Following Laparoscopic Sleeve Gastrectomy Surgery

Not Applicable

Completed

• Conditions: Postoperative Pain After Laparoscopic Sleeve Gastrectomy
• Interventions: Procedure: intraperitoneal local anaesthetic instillation

• Registration Number: NCT04370392
• Lead Sponsor: Tanta University

Brief Summary

One of most common bariatric surgery is laparoscopic sleeve gastrectomy. Pain after laparoscopic surgery may be due to stretching of the intra-abdominal cavity, peritoneal inflammation, and diaphragmatic irritation caused by residual carbon-dioxide in the peritoneal cavity.Multimodal efforts like parenteral opioids, non-steroidal anti-inflammatory drugs or local wound infiltration have been done to reduce overall pain and benefit post-operative conditions of patients undergoing laparoscopic surgeries. Despite their efficacy, with all parenteral medications, there are associated adverse effects.

Intraperitoneal local anesthetic is a safe and effective analgesic approach which used to control pain after laparoscopic surgery. Many authors have evaluated the role of IP local anesthetic administration in laparoscopic colorectal cancer surgery, laparoscopic cholecystectomy, laparoscopic appendectomy and laparoscopic hysterectomy

Detailed Description

Laparoscopic procedures have many advantages over open procedures such as lesser haemorrhage, better cosmetic results, lesser post-operative pain, and shorter recovery time, leading to shorter hospital stay and less expenditure.One of most common bariatric surgery is laparoscopic sleeve gastrectomy. Pain after laparoscopic surgery may be due to stretching of the intra-abdominal cavity, peritoneal inflammation, and diaphragmatic irritation caused by residual carbon-dioxide in the peritoneal cavity.

Multimodal efforts like parenteral opioids, non-steroidal anti-inflammatory drugs or local wound infiltration have been done to reduce overall pain and benefit post-operative conditions of patients undergoing laparoscopic surgeries. Despite their efficacy, with all parenteral medications, there are associated adverse effects.

Intraperitoneal local anesthetic is a safe and effective analgesic approach which used to control pain after laparoscopic surgery. Many authors have evaluated the role of IP local anesthetic administration in laparoscopic colorectal cancer surgery, laparoscopic cholecystectomy, laparoscopic appendectomy and laparoscopic hysterectomy.

Dexmedetomidine (alpha-2 adrenergic agonists) has become one of the frequently used drugs in anesthesia as it has been reported to provide analgesia, anxiolysis, and an anesthetic-sparing action with minimal respiratory depression plus its sedative effect that mimics natural sleep. Dexmedetomidine can used safely both intravenous and plus bupivacaine in different nerve block.

Study Timeline

• Study First Submitted: 2020-04-28
• Study First Submitted QC: 2020-04-28
• Study First Posted: 2020-04-30
• Study Start: 2020-05-01
• Primary Completion: 2020-10-30
• Status Verified: 2020-12
• Study Completion: 2020-12-01
• Last Update Submitted: 2020-12-05
• Last Update Posted: 2020-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• Patients undergoing laparoscopic sleeve gastrectomy who meet the known criteria for bariatric procedures (BMI ≥ 40 or 35 with comorbidities related to obesity or obesity for more than 5 years with all efforts to reduce weight failing).

Exclusion Criteria

• 1. Cardiac patients, 2. patients with known allergy to bupivacaine, 3. prolonged administration of NSAIDS or other analgesics due to chronic pain of any reason, 4. severe renal and hepatic diseases, 5. on antihypertensive medication with any α2 adrenergic agonists, e.g., clonidine or beta blockers 6. heart block.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV dexmedetomidine group	intraperitoneal local anaesthetic instillation	intraperitoneal local anesthetic instillation (40 ml bupivacaine 0.25%) through the trocar with intravenous infusion of 50 ml normal saline containing dexmedetomidine 1 ug/kg over 10 minutes.
IP dexmedetomidine group	intraperitoneal local anaesthetic instillation	intraperitoneal anesthetic instillation (40 ml total volume containing bupivacaine 0.25% with dexmedetomidine 1 ug/kg) through the trocar with intravenous infusion of 50 ml normal saline over 10 minutes.
control group	intraperitoneal local anaesthetic instillation	intraperitoneal local anesthetic instillation (40 ml bupivacaine 0.25%) through the trocar with intravenous infusion of 50 ml normal saline over 10 minutes.

Primary Outcome Measures

Name	Time	Method
Time of first analgesic request	postoperative first day	Time of first analgesic request when visual analogue score more than 3

Secondary Outcome Measures

Name	Time	Method
postoperative pain assessment	postoperative first day	Assessment of postoperative pain with Visual analogue scale
Total amount of rescue analgesia	postoperative first day	Total amount of rescue tramadol analgesia
Number of patients who needed postoperative rescue analgesia	postopertive first day	Number of patients who needed postoperative rescue tramadol analgesia

Trial Locations

Locations (1)

Tarek Abdel Hay; 🇪🇬 Tanta, El Gharbyia, Egypt