ACB Versus IA Analgesia in Knee Arthroscopy
Adductor Canal Block Versus Intra-articular Analgesia for Postoperative Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction: a Randomized Trial
1 other identifier
interventional
72
1 country
1
Brief Summary
Reconstruction of the anterior cruciate ligament (ACL) of the knee is a painful procedure, and effective postoperative analgesia is important for early return of patient activity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 postoperative-pain
Started May 2021
Longer than P75 for phase_2 postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2021
CompletedFirst Posted
Study publicly available on registry
January 20, 2021
CompletedStudy Start
First participant enrolled
May 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2023
CompletedJune 14, 2024
June 1, 2024
2.2 years
January 15, 2021
June 13, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
The pain free time after surgery
assessed in minutes
1440 minutes (24 hours) after surgery
Study Arms (2)
ACB group
ACTIVE COMPARATORPatients will receive ultrasound-guided (USG) ACB with bupivacaine and dexamethasone 30 minutes before spinal anesthesia and sham intra-articular normal saline.
IA group
PLACEBO COMPARATORPatients will receive intra-articular bupivacaine and dexamethasone at the end of surgery and sham USG-ACB with normal saline.
Interventions
Patients will receive ultrasound-guided (USG) ACB with bupivacaine and dexamethasone 30 minutes before spinal anesthesia and sham intra-articular normal saline
Patients will receive intra-articular bupivacaine and dexamethasone at the end of surgery and sham USG-ACB with normal saline
Eligibility Criteria
You may qualify if:
- Patients undergoing elective arthroscopic reconstruction of the anterior cruciate ligament (ACL) under spinal anesthesia, aged from 18 to 65 years old
You may not qualify if:
- Contraindications to peripheral nerve block (e.g. allergy to local anesthetics, coagulopathy, infection in the area)
- History of cardiovascular, cerebrovascular, and respiratory diseases
- Preexisting neuropathies
- Chronic pain syndrome
- Opioid dependence
- Patients with diabetes mellitus, sever hypertension, hepatic or renal dysfunction
- Pregnancy
- Not willingness to participate.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seham Mohamed Moeen
Asyut, 71515, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seham M Moeen, MD
Assiut University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 15, 2021
First Posted
January 20, 2021
Study Start
May 20, 2021
Primary Completion
July 31, 2023
Study Completion
July 31, 2023
Last Updated
June 14, 2024
Record last verified: 2024-06