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

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

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

Study Overview

• Status: Completed
• Conditions: Postoperative Pain After Laparoscopic Sleeve Gastrectomy
• Intervention / Treatment: Procedure: intraperitoneal local anaesthetic instillation

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 Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El Gharbyia
    • Tanta, El Gharbyia, Egypt, 31527
      • Tarek Abdel Hay

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group; intraperitoneal local anesthetic instillation (40 ml bupivacaine 0.25%) through the trocar with intravenous infusion of 50 ml normal saline over 10 minutes.	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.
Experimental: IV dexmedetomidine group; 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.	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.
Experimental: IP dexmedetomidine group; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of first analgesic request	Time of first analgesic request when visual analogue score more than 3	postoperative first day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative pain assessment	Assessment of postoperative pain with Visual analogue scale	postoperative first day
Total amount of rescue analgesia	Total amount of rescue tramadol analgesia	postoperative first day
Number of patients who needed postoperative rescue analgesia	Number of patients who needed postoperative rescue tramadol analgesia	postopertive first day

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): October 30, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: April 28, 2020
• First Posted (Actual): April 30, 2020

Study Record Updates

• Last Update Posted (Actual): December 8, 2020
• Last Update Submitted That Met QC Criteria: December 5, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: IV and IP detomidinemidine

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No