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

Phase 3RecruitingNCT06665438

Al-Azhar University75 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Post Operative Analgesia

Interventions

Normal Saline (Placebo)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

Bupivacaine 0.25%DRUG

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

DexmedetomidineDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (2)

Al-Azhar University

Asyut, Egypt

RECRUITING

Al-Azhar University

Asyut, Egypt

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

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

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

Time frame: post operative at 30 minute, 1 hour, 2 hour, 4 hour, 6 hour, 12 hour, and 24 hour .

Secondary Outcomes

Total meperidine consumption . Meperidine will be used intravenously if the visual analog scale ( VAS) score was >50 to control postoperative pain.

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.

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.

Central Contacts

Mohamed A. Mahmoud, MD

CONTACT

01002538320 mohamedali.226@azhar.edu.eg

Warda D.K. Ali, MD

CONTACT

012224668648 d.wardah8888@gmail.com

Data from ClinicalTrials.gov

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