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

Impact of Dexmedetomidine Add to Intra-articular Bupivacaine for Post Operative Analgesia After Knee Arthroscopic Surgery

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06665438
Acronym
DEXMED
Enrollment
75
Registered
2024-10-30
Start date
2024-12-01
Completion date
2025-04-30
Last updated
2025-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Analgesia

Keywords

Knee arthroscopy, Bupivacaine, Dexmedetomidine, Postoperative pain

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.

Interventions

DRUGNormal 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

DRUGBupivacaine 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

DRUGDexmedetomidine

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

Sponsors

Al-Azhar University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Intervention model description

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)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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 surgerypost 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

MeasureTime frameDescription
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.

Countries

Egypt

Contacts

Primary ContactMohamed A. Mahmoud, MD
mohamedali.226@azhar.edu.eg01002538320
Backup ContactWarda D.K. Ali, MD
d.wardah8888@gmail.com012224668648

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026