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

Primary Purpose

Postoperative Pain After Laparoscopic Sleeve Gastrectomy

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
intraperitoneal local anaesthetic instillation
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain After Laparoscopic Sleeve Gastrectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tarek Abdel Hay

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

control group

IV dexmedetomidine group

IP dexmedetomidine group

Arm Description

intraperitoneal local anesthetic instillation (40 ml bupivacaine 0.25%) through the trocar with intravenous infusion of 50 ml normal saline over 10 minutes.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

postoperative pain assessment
Assessment of postoperative pain with Visual analogue scale
Total amount of rescue analgesia
Total amount of rescue tramadol analgesia
Number of patients who needed postoperative rescue analgesia
Number of patients who needed postoperative rescue tramadol analgesia

Full Information

First Posted
April 28, 2020
Last Updated
December 5, 2020
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT04370392
Brief Title
Intraperitoneal Versus Intravenous Dexmedetomidine for Post-operative Analgesia Following Laparoscopic Sleeve Gastrectomy Surgery
Official Title
Intraperitoneal Versus Intravenous Dexmedetomidine for Post-operative Analgesia Following Laparoscopic Sleeve Gastrectomy Surgery, A Prospective Randomized Control Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain After Laparoscopic Sleeve Gastrectomy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Active Comparator
Arm Description
intraperitoneal local anesthetic instillation (40 ml bupivacaine 0.25%) through the trocar with intravenous infusion of 50 ml normal saline over 10 minutes.
Arm Title
IV dexmedetomidine group
Arm Type
Experimental
Arm Description
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.
Arm Title
IP dexmedetomidine group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
intraperitoneal local anaesthetic instillation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time of first analgesic request
Description
Time of first analgesic request when visual analogue score more than 3
Time Frame
postoperative first day
Secondary Outcome Measure Information:
Title
postoperative pain assessment
Description
Assessment of postoperative pain with Visual analogue scale
Time Frame
postoperative first day
Title
Total amount of rescue analgesia
Description
Total amount of rescue tramadol analgesia
Time Frame
postoperative first day
Title
Number of patients who needed postoperative rescue analgesia
Description
Number of patients who needed postoperative rescue tramadol analgesia
Time Frame
postopertive first day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Tarek Abdel Hay
City
Tanta
State/Province
El Gharbyia
ZIP/Postal Code
31527
Country
Egypt

12. IPD Sharing Statement

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

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