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

NCT04370392 | Completed DMC

• 1 other identifier: IV and IP detomidinemidine
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Pain After Laparoscopic Sleeve Gastrectomy

Outcome Measures

Primary Outcomes (1)

• Time of first analgesic request

  Time of first analgesic request when visual analogue score more than 3

  postoperative first day

Secondary Outcomes (3)

• postoperative pain assessment

  postoperative first day

• Total amount of rescue analgesia

  postoperative first day

• Number of patients who needed postoperative rescue analgesia

  postopertive first day

Study Arms (3)

control group

ACTIVE COMPARATOR

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

IV dexmedetomidine group

EXPERIMENTAL

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

IP dexmedetomidine group

EXPERIMENTAL

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

Interventions

intraperitoneal local anaesthetic instillation PROCEDURE

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.

IP dexmedetomidine group; IV dexmedetomidine group; control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tarek Abdel Hay

Tanta, El Gharbyia, 31527, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: April 30, 2020
• Study Start: May 1, 2020
• Primary Completion: October 30, 2020
• Study Completion: December 1, 2020
• Last Updated: December 8, 2020

Record last verified: 2020-12

Locations

EG (1)