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

Al-Azhar University

Status and phase: Enrolling; Phase 3

Conditions: Post Operative Analgesia

Treatments: Drug: Normal Saline (Placebo); Drug: Dexmedetomidine; Drug: Bupivacaine 0.25%

Study type: Interventional

Funder types: Other

Identifiers

NCT06665438

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

Details and patient eligibility

About

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

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 3 patient groups

group of control (C)

Experimental group

Description:

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

Treatment:

Drug: Normal Saline (Placebo)

groups of Bupivacaine (B)

Experimental group

Description:

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

Treatment:

Drug: Bupivacaine 0.25%

Drug: Dexmedetomidine

groups of dexmedetomidine (D)

Experimental group

Description:

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

Treatment:

Drug: Dexmedetomidine