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

NCT ID: NCT06665438

Last Updated: 2025-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2025-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Post Operative Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

patients randomly allocate to one of three groups (n =25) for intra articular injection using Sealed envelope method as follows: Group (C), receive 18 ml saline only and serve as the control group(C). Group (B) receive 18ml 0.25% bupivacaine. Group(D)received 18 ml 0.25% bupivacaine and dexmedetomidine 1 μg/kg, the study drugs will injected in the knee joint by the surgeon through the arthroscope after completing the procedure (without knowing the drugs used)
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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

Group Type EXPERIMENTAL

Normal Saline (Placebo)

Intervention Type DRUG

the 18 ml of normal saline will injected intra articular in the knee joint by the surgeon through the arthroscope after completing the procedure

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

Group Type EXPERIMENTAL

Bupivacaine 0.25%

Intervention Type DRUG

the 18ml 0.25% bupivacaine. will injected intra articular in the knee joint by the surgeon through the arthroscope after completing the procedure

Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine 1 μg/kg will injected intra articular in the knee joint by the surgeon through the arthroscope after completing the procedure.

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.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine 1 μg/kg will injected intra articular in the knee joint by the surgeon through the arthroscope after completing the procedure.

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Dexmedetomidine

Dexmedetomidine 1 μg/kg will injected intra articular in the knee joint by the surgeon through the arthroscope after completing the procedure.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Ali Mahmoud

Lecturer of anesthesia, intensive care and pain management

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Al-Azhar University

Asyut, , Egypt

Site Status RECRUITING

Al-Azhar University

Asyut, , Egypt

Site Status NOT_YET_RECRUITING

Countries

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Egypt

Central Contacts

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Mohamed A. Mahmoud, MD

Role: CONTACT

01002538320 ext. 002

Warda D.K. Ali, MD

Role: CONTACT

012224668648 ext. 002

Facility Contacts

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Mohamed A. Mahmoud, M.D

Role: primary

01002538320 ext. 002

Mohamed A Mahmoud, M.D

Role: backup

01002538320 ext. 002

Mohamed A. Mahmoud

Role: primary

01002538320 ext. 002

Mohamed A Mahmoud

Role: backup

01002538320 ext. 002

Other Identifiers

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AZAST/Research/88/14-MAY-2024.

Identifier Type: -

Identifier Source: org_study_id

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