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

NCT06665438 | Recruiting Phase 3

• 1 other identifier: AZAST/Research/88/14-MAY-2024.
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

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

Conditions

Post Operative Analgesia

Keywords

Knee arthroscopy; Bupivacaine; Dexmedetomidine; Postoperative pain

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (1)

• 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.

Study Arms (3)

group of control (C)

EXPERIMENTAL

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)

groups of Bupivacaine (B)

EXPERIMENTAL

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%; Drug: Dexmedetomidine

groups of dexmedetomidine (D)

EXPERIMENTAL

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

Drug: Dexmedetomidine

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

group of control (C)

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

groups of Bupivacaine (B)

Dexmedetomidine 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 Bupivacaine (B); groups of dexmedetomidine (D)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-II patients
• Either sex
• Aged 18-65 years
• Candidates for anterior cruciate ligament (ACL) reconstruction by knee arthroscopy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (2)

Al-Azhar University

Asyut, 71523, Egypt

RECRUITING

Al-Azhar University

Asyut, Egypt

NOT YET RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Saline Solution; Dexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Mohamed A. Mahmoud, MD

CONTACT

01002538320; mohamedali.226@azhar.edu.eg

Warda D.K. Ali, MD

CONTACT

012224668648; d.wardah8888@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia, intensive care and pain management

Model Details: 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)

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 30, 2024
• Study Start: December 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 22, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)