Dexmedetomidine and Bupivacaine Intra-articular for Postoperative Analgesia After Knee Arthroscopic Surgery (DEXMED)

April 20, 2025 updated by: Mohamed Ali Mahmoud, Al-Azhar University

Impact of Dexmedetomidine Add to Intra-articular Bupivacaine for Post Operative Analgesia After Knee Arthroscopic Surgery

The aim of this study to compare the analgesic effects of intraarticular dexmedetomidine added to bupivacaine with those of bupivacaine alone after knee arthroscopy

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

prospective double-blind study perform on 75 patients candidates for anterior cruciate ligament (ACL) reconstruction by knee arthroscopy refer to the clinic of Al Azhar University Hospital, Assiut, Egypt, to evaluate the effect of adding dexmedetomidine to intra articular bupivacaine injection on postoperative pain after knee arthroscopy.

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • 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 Contact

Study Contact Backup

Study Locations

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ASA I-II patients
  • Either sex
  • Aged 18-65 years
  • Candidates for anterior cruciate ligament (ACL) reconstruction by knee arthroscopy
  • Exclusion Criteria:
  • the patients with kidney failure, liver failure, valvular and ischemic heart disease , high blood pressure, diabetes, history of infection and malignancy.
  • history of coagulation diseases, and history of drug allergies to used drugs.
  • those who consumed NSAIDs and analgesics 24 h before surgery were excluded from the study.

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: group of control (C)
receive 18 ml of normal saline only and serve as the control group.the normal saline will injected in the knee joint by the surgeon through the arthroscope after completing the procedure
Drug: Normal Saline (Placebo)
the 18 ml of normal saline will injected intra articular in the knee joint by the surgeon through the arthroscope after completing the procedure
Experimental: groups of Bupivacaine (B)
The 18ml 0.25% bupivacaine will injected intra articular in the knee joint by the surgeon through the arthroscope after completing the procedure
Drug: Bupivacaine 0.25%
the 18ml 0.25% bupivacaine. will injected intra articular in the knee joint by the surgeon through the arthroscope after completing the procedure
Drug: Dexmedetomidine
Dexmedetomidine 1 μg/kg will injected intra articular in the knee joint by the surgeon through the arthroscope after completing the procedure.
Experimental: groups of dexmedetomidine (D)
Dexmedetomidine 1 μg/kg will injected intra articular in the knee joint by the surgeon through the arthroscope after completing the procedure.
Drug: Dexmedetomidine
Dexmedetomidine 1 μg/kg will injected intra articular in the knee joint by the surgeon through the arthroscope after completing the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change on the visual analog scale (VAS) for pain (0 = no pain to 100 = the maximum pain )to assessment the duration of analgesia following the surgery
Time Frame: post operative at 30 minute, 1 hour, 2 hour, 4 hour, 6 hour, 12 hour, and 24 hour .
Change on the visual analog scale (VAS) for pain (0 = no pain to 100 = the maximum pain) to assessment the duration of analgesia following intra articular injection of Bupivacaine and Dexmedetomidine after knee arthroscopy
post operative at 30 minute, 1 hour, 2 hour, 4 hour, 6 hour, 12 hour, and 24 hour .

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total meperidine consumption . Meperidine will be used intravenously if the visual analog scale ( VAS) score was >50 to control postoperative pain.
Time Frame: The total dose of meperidine given between the study groups during the first 24 hour( post operative at 30 minute, 1 hour, 2 hour, 4 hour, 6 hour, 12 hour, and 24 hour),will be recorded.
the secondary outcome variables will be the total dose of meperidine given between the study groups.Meperidine will be used intravenously if the visual analog scale ( VAS) score was >50 to control postoperative pain.
The total dose of meperidine given between the study groups during the first 24 hour( post operative at 30 minute, 1 hour, 2 hour, 4 hour, 6 hour, 12 hour, and 24 hour),will be recorded.

Collaborators and Investigators

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

Sponsor

Al-Azhar University

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)

December 1, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

October 21, 2024

First Submitted That Met QC Criteria

October 29, 2024

First Posted (Actual)

October 30, 2024

Study Record Updates

Last Update Posted (Actual)

April 22, 2025

Last Update Submitted That Met QC Criteria

April 20, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AZAST/Research/88/14-MAY-2024.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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.

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