Postoperative Analgesic Effectiveness of Bupivacaine With and Without Dexmedetomidine in Patients With Abdominal Surgery

July 29, 2024 updated by: Muhammad Shahid, Sahiwal medical college sahiwal

Comparison of Postoperative Analgesic Effectiveness of Bupivacaine and Bupivacaine Plus Dexmedetomidine Wound Infiltration in Abdominal Surgeries Under General Anesthesia

Abdominal surgeries are major surgical procedures that are performed at any teaching hospital. Pain control is major concern in the intra-operative as well as post-operative period in these patients. Optimal pain control in post-operative period is directly related to patient's recovery, shortens the patients' hospital stay and overall burden on health facilities. Inadequate pain control may affect quality of life and increases patient's morbidity and mortality. Different modalities for pain control are used in post-operative period. Opioids are mainstay of treatment in post-operative period but historically are associated with significant side effect profile like dependence, nausea, vomiting, respiratory depression, constipation and many others. Dexmedetomidine is centrally acting α-2 adrenoceptor agonist.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This randomized controlled trial was conducted at Department of Anesthesia, Sahiwal Teaching Hospital, Sahiwal. After institutional review board (IRB) approval, computer-generated random number table was used to randomize the patients to two groups, one group received Bupivacaine plus placebo and the other group received Bupivacaine plus dexmedetomidine. A total of 64 patients met the inclusion criteria and were enrolled in the study in a 1:1. Informed written consent was obtained from all the patients before enrolling them in the study. All patients underwent a pre-operative assessment on the day before surgery. Both groups received wound infiltration with studied drugs at the end of surgery. After surgery patients were shifted to post-surgical ward and assessed for pain using visual analogue scale (VAS) and data was collected and analyzed using Statistical Package for the Social Sciences (SPSS) version 26. Quantitative variables were presented with mean ±SD. Comparison of quantitative variable between groups was done using independent sample t-test. Comparison of qualitative variable like (Opioid sparing effect, Bradycardia, Hypotension, Nausea, Vomiting) was presented with frequency and percentages. Data was stratified on the basis of gender and age. Post-stratification chi-square test was used to compare both groups for opioid sparing effect in each stratum with p-value ≤0.05 as significant.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 2
  • Phase 3

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

  • Pakistan
    • Punjab
      • Sahiwal, Punjab, Pakistan, 57000
        • Sahiwal Medical College

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age limit: 18-60 years
  2. Gender of patient i.e., male or female
  3. Patients listed for abdominal surgeries
  4. American Society of Anesthesiologists (ASA) status of I or II

Exclusion Criteria:

  1. Patients with history of drug allergy
  2. Patients who undergone any analgesia in past 24 hr
  3. Patients with liver disease, kidney disease, cardiac disease, sickle cell anemia, severe preeclampsia or CNS disorder on history, clinical and laboratory assessment
  4. American Society of Anesthesiologists (ASA) status III or IV
  5. Patients with morbid obesity 6, Raynaud's disease Patients on adrenoceptor agonists, antagonists or narcotics before the operation.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bupivacaine group
Patients receiving Bupivacaine plus placebo for wound infiltration after abdominal surgery for pain control.
Drug: bupivacaine wound infilteration
drug was given at the end of surgery
Other Names:
  • LA infiltration
Experimental: Bupivacaine plus Dexmedetomidine group
Patients receiving Bupivacaine plus Dexmedetomidine for wound infiltration after abdominal surgery for pain control.
Drug: Bupivacaine plus dexmedetomidine wound infilteration
drug was given at the end of surgery
Other Names:
  • LA + Dex infiltration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of analgesia
Time Frame: Every 30 mints for 4hrs than 2hrly for 24 hrs post procedure
Time from procedure to requirement of rescue analgesia
Every 30 mints for 4hrs than 2hrly for 24 hrs post procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid sparing
Time Frame: Total dose of nalbuhine consumption in 1st 24 hrs after procedure
Total amount of opioid consumtion in the first 24 post procedure.
Total dose of nalbuhine consumption in 1st 24 hrs after procedure
Blood pressure
Time Frame: Every 15 minutes intra operative and every 15 minutes for 24 hrs postoperatively
Mean pressue will be measured
Every 15 minutes intra operative and every 15 minutes for 24 hrs postoperatively
Hear rate
Time Frame: Every 15 minutes intraoperative and every 15 minutes postoperatively for 24 hrs
Heart rate will be measured
Every 15 minutes intraoperative and every 15 minutes postoperatively for 24 hrs
Neausea
Time Frame: Every 30 minutes for 4 hrs then 2hrly for 24 hrs
Felling of nasueas
Every 30 minutes for 4 hrs then 2hrly for 24 hrs
Vomiting
Time Frame: Every 3 minutes for first 4 hrs then 2hrly for 24 hrs
Urge to vomit
Every 3 minutes for first 4 hrs then 2hrly for 24 hrs

Collaborators and Investigators

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

Sponsor

Sahiwal medical college sahiwal

Investigators

  • Principal Investigator: M. Shahid, FCPS, Sahiwal medical college sahiwal
  • Study Director: A. Riaz, MD, Sahiwal medical college sahiwal

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)

February 20, 2022

Primary Completion (Actual)

January 20, 2023

Study Completion (Actual)

April 20, 2023

Study Registration Dates

First Submitted

July 3, 2024

First Submitted That Met QC Criteria

July 29, 2024

First Posted (Actual)

August 1, 2024

Study Record Updates

Last Update Posted (Actual)

August 1, 2024

Last Update Submitted That Met QC Criteria

July 29, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB29

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We will not share individualized data, but the outcomes of the study will be shared in the form of manuscript.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Nausea

Clinical Trials on bupivacaine wound infilteration

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe