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

Postoperative Pain After Laparoscopic Sleeve Gastrectomy Clinical Trial

Official title:

Intraperitoneal Versus Intravenous Dexmedetomidine for Post-operative Analgesia Following Laparoscopic Sleeve Gastrectomy Surgery, A Prospective Randomized Control Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04370392
• Other study ID #: IV and IP detomidinemidine
• Status: Completed
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: December 2020
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 1, 2020
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 a2 adrenergic agonists, e.g., clonidine or beta blockers 6. heart block.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain After Laparoscopic Sleeve Gastrectomy

Intervention

Procedure:
• intraperitoneal local anaesthetic instillation
intraperitoneal anesthetic instillation (40 ml total volume containing bupivacaine 0.25) through the trocar at the subdiaphragmatic space in Trendelenburg's position for 5 min with intravenous infusion of 50 ml normal saline over 10 minutes.

Locations

Country	Name	City	State
Egypt	Tarek Abdel Hay	Tanta	El Gharbyia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of first analgesic request	Time of first analgesic request when visual analogue score more than 3	postoperative first day
Secondary	postoperative pain assessment	Assessment of postoperative pain with Visual analogue scale	postoperative first day
Secondary	Total amount of rescue analgesia	Total amount of rescue tramadol analgesia	postoperative first day
Secondary	Number of patients who needed postoperative rescue analgesia	Number of patients who needed postoperative rescue tramadol analgesia	postopertive first day