Intraperitoneal Dexmedetomidine Versus Ketamine With Bupivacaine For Postoperative Analgesia

April 26, 2023 updated by: Rehab Abd-Allah Wahdan, Zagazig University

Comparative Study Between Intraperitoneal Dexmedetomidine Versus Ketamine With Bupivacaine For Postoperative Analgesia After Laparoscopic Sleeve Gastrectomy

Post-laparoscopic sleeve pain management is essential for early mobilization of the patient and so on decrease post-operative complication. The use of opioids is associated with adverse effects such as nausea, pruritus, sedation, and occasionally respiratory depression.

Previous studies stated that intraperitoneal instillation of bupivacaine alone has been used to reduce acute postoperative abdominal and shoulder pain allow early mobilization and decrease postoperative opioid requirements and its complications.

In this study the investigators will compare between intraperitoneal instillation of dexmedetomidine with bupivacaine versus ketamine with bupivacaine in patients undergoing laparoscopic sleeve gastrectomy under general anesthesia regarding to postoperative pain relief to reduce morbidity and mortality.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Obesity is a serious condition in developed and developing countries occur due to some hormonal disorder or due to reduce energy expenditure with increasing energy uptake [1]. Nowadays, obesity considered the second cause of deaths after smoking all over the world [2].

Severe obesity increase the incidence of many chronic disease such as (diabetes mellitus, hypertension, cardiovascular diseases and others) [3]. This leads to substantial morbidity, early mortality [4], impaired quality of life [5] and excess healthcare expenditures [6].

Laparoscopic bariatric surgery is the most recommended and effective long-term treatment for morbid obesity (which body mass index (BMI) ≥40 kg/m2) and obesity-related complication [7].

Postoperative pain management after laparoscopic sleeve still considers a major challenge. As many of the patients express moderate-to-severe pain in postoperative period [8]. Causes of postoperative pain include inflammation of the peritoneum, intra-abdominal cavity stretch and irritation of diaphragm by carbon-dioxide (CO2) remains in the abdominal cavity [9].

Multimodal analgesia regimens such as parenteral opioids, nonsteroidal anti-inflammatory drugs and intraperitoneal instillation of different drugs such as local anesthetic drugs alone or with adjuvants like; opioid and α2 agonists' drugs such as clonidine and dexmedetomidine have been tried to reduce overall pain and postoperative complications of patients undergoing laparoscopic surgeries [8, 9].

Bupivacaine is the most commonly used local anesthetic drug, its intraperitoneal instillation has become a popular practice for pain relief after laparoscopic surgery as it causes blockade of free afferent nerve endings in peritoneum [10].

Dexmedetomidine, the pharmacologically active d-isomer of medetomidine, it is a potent and highly selective α2-adrenoreceptor agonist with sympatholytic, sedative, amnestic, anxiolytic, neuroprotective and analgesic properties [11].

Ketamine is an immunomodulatory agent and anti-inflammatory drug and it has a noncompetitive antagonist of the N-methyl-d-aspartate (NMDA) receptor that blocks nociceptive input and reduce hyperalgesia [12].

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Elsharqya
      • Zagazig, Elsharqya, Egypt, 44519
        • Faculty of Medicine, Zagazig University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient acceptance.
  • Age 21-60 years old.
  • Sex both male and female.
  • BMI ≥40 kg/m2
  • ASA II and ASA III.
  • Scheduled for elective laparoscopic sleeve gastrectomy under general anesthesia.

Exclusion Criteria:

  • Patients with known history of allergy to study drugs.
  • Patients with uncontrolled diabetes mellitus.
  • Psychological and mental disorders.
  • Severe hypertensive, cardiac, hepatic and renal patients.
  • Patients on opioid or sedative use.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: control group
patient will receive 40 ml bupivacaine 0.25% + 5 ml normal saline with a total volume of 45 ml to be installed intraperitoneally.
Drug: normal saline

At the end of surgery, patient will be shifted to Trendelenburg position and intraperitoneal instillation of 40 ml bupivacaine 0.25% + 5 ml normal saline will be done guided by the camera and sprayed uniformly into the peritoneal cavity by the surgeon.

The patient will be maintained in Trendelenburg position for 5-10 minutes after drug instillation and the abdomen will be deflated by passive exsufflation using gentle abdominal pressure.
Active Comparator: dexmedetomidine group
patient will receive 40 ml bupivacaine 0.25% + 1 µg/kg dexmedetomidine diluted in 5 ml normal saline with a total volume of 45 ml to be installed intraperitoneally.
Drug: dexmedetomidine

At the end of surgery, patient will be shifted to Trendelenburg position and intraperitoneal instillation of the study drug(40 ml bupivacaine 0.25% + 1 µg/kg dexmedetomidine diluted in 5 ml normal saline) will be done guided by the camera and sprayed uniformly into the peritoneal cavity by the surgeon.

The patient will be maintained in Trendelenburg position for 5-10 minutes after drug instillation and the abdomen will be deflated by passive exsufflation using gentle abdominal pressure.
Active Comparator: ketamine group
patient will receive 40 ml bupivacaine 0.25% + 0.5 mg/kg ketamine diluted in 5 ml normal saline with a total volume of 45 ml to be installed intraperitoneally.
Drug: Ketamine

At the end of surgery, patient will be shifted to Trendelenburg position and intraperitoneal instillation of the study drug(40 ml bupivacaine 0.25% + 0.5 mg/kg ketamine diluted in 5 ml normal saline) will be done guided by the camera and sprayed uniformly into the peritoneal cavity by the surgeon.

The patient will be maintained in Trendelenburg position for 5-10 minutes after drug instillation and the abdomen will be deflated by passive exsufflation using gentle abdominal pressure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in assessment of postoperative shoulder, abdominal and incisional pain
Time Frame: at 1, 2, 4, 6, 12 and 24 hours postoperatively
will be assessed by visual analogue scale (VAS) scale, On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain.
at 1, 2, 4, 6, 12 and 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of first request of analgesia
Time Frame: within 24 hour postoperative
time elapsed from patient arrival to PACU [T0] to time of first patient call for analgesia
within 24 hour postoperative
Total rescue analgesic requirement
Time Frame: during the first postoperative 24 hours
if VAS ≥3 or on patient request, rescue analgesia will be given
during the first postoperative 24 hours
The incidence of postoperative nausea and vomiting (PONV)
Time Frame: during the first postoperative 24 hours
occurrence of postoperative nausea and vomiting
during the first postoperative 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

April 30, 2022

Study Completion (Actual)

May 20, 2022

Study Registration Dates

First Submitted

August 16, 2020

First Submitted That Met QC Criteria

August 22, 2020

First Posted (Actual)

August 25, 2020

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-7-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

planned after the completion of the study and publication

IPD Sharing Time Frame

planned after the completion of the study and publication

IPD Sharing Access Criteria

principal investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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