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

Phase 3

Recruiting

• Conditions: Post Operative Analgesia
• Interventions: Drug: Normal Saline (Placebo); Drug: Bupivacaine 0.25%; Drug: Dexmedetomidine

• Registration Number: NCT06665438
• Lead Sponsor: Al-Azhar University

Brief Summary

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

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 Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-21
• Study First Submitted QC: 2024-10-29
• Study First Posted: 2024-10-30
• Study Start: 2024-12-01
• Primary Completion: 2025-04
• Study Completion: 2025-04
• Last Update Submitted: 2025-04-20
• Last Update Posted: 2025-04-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group of control (C)	Normal Saline (Placebo)	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
groups of Bupivacaine (B)	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
groups of Bupivacaine (B)	Dexmedetomidine	The 18ml 0.25% bupivacaine will injected intra articular in the knee joint by the surgeon through the arthroscope after completing the procedure
groups of dexmedetomidine (D)	Dexmedetomidine	Dexmedetomidine 1 μg/kg will injected intra articular in the knee joint by the surgeon through the arthroscope after completing the procedure.

Primary Outcome Measures

Name	Time	Method
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	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

Secondary Outcome Measures

Name	Time	Method
Total meperidine consumption . 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.	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.

Trial Locations

Locations (1)

Al-Azhar University; 🇪🇬 Assiut, Egypt