The Analgesic Efficacy of Ultrasound Guided Adductor Canal Block Versus 4 in 1 Block in Patients Undergoing Knee Surgeries: A Comparative Randomized Double Blinded Study .
No acronym
1 other identifier
interventional
40
1 country
1
Brief Summary
Knee surgeries are associated with severe postoperative pain. Improper pain management affects patients' psychological status with prolongation of hospital stay time and rehabilitation period, with the possibility of progression of the acute pain to chronic pain (McCartney CJ, Nelligan K., 2014). Many Pain management options following these surgeries are available: non-opioid analgesics, opioids and regional anesthesia techniques (epidural and peripheral nerve block). Multi-modal analgesia is considered the best option for pain management in knee surgeries. As non-opioid analgesics alone are not effective enough while opioids alone are associated with many risk factors: nausea, vomiting, decrease intestinal motility and respiratory depression with possibility of addiction (Goode VM, Morgan B, et al, 2019)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2023
Shorter than P25 for not_applicable
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
March 2, 2023
CompletedStudy Start
First participant enrolled
April 1, 2023
CompletedFirst Posted
Study publicly available on registry
April 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2024
CompletedAugust 19, 2024
August 1, 2024
8 months
March 2, 2023
August 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Postoperative pain score: resting and dynamic .
Postoperative pain score: resting and dynamic pain using NRS at postoperative 6 hours.Numerical rating scales (NRSs) are the simplest and most commonly used scales. The numerical scale is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable." The patient picks (verbal version) or draws a circle around (written version) the number that best describes the pain dimension, usually intensity.
6 hours Postoperative
Postoperative pain score: resting and dynamic
Postoperative pain score: resting and dynamic pain using NRS at postoperative 12 hours.
12 hours post operative
Postoperative pain score: resting and dynamic
Postoperative pain score: resting and dynamic pain using NRS at postoperative 18 hours.
18 hours post operative
Postoperative pain score: resting and dynamic
Postoperative pain score: resting and dynamic pain using NRS at postoperative 24 hours.
24 hours post operative.
Secondary Outcomes (3)
Change of blood pressure .
Intraoperative
Change of heart rate .
Intraoperative
Postoperative opioid requirements .
24 hours post operative
Study Arms (2)
adductor canal block
ACTIVE COMPARATORadductor canal block : patients will receive an injection of 30 ml of .25% of Bupivacaine including 4mg of dexamethasone at a point anterior to the femoral artery, deep to the sartorius muscle
4 in one block
ACTIVE COMPARATOR4 in one block : patients will receive an injection of 30 ml of .25% of Bupivacaine including 4mg dexamethasone at the adductor hiatus where the descending genicular artery branches from superficial femoral artery .
Interventions
patients will receive an injection of 30 ml of .25% of Bupivacaine including 4mg of dexamethasone at a point anterior to the femoral artery, deep to the sartorius muscle (adductor canal block).
patients will receive an injection of 30 ml of .25% of Bupivacaine including 4mg dexamethasone at the adductor hiatus where the descending genicular artery branches from superficial femoral artery (4 in one block).
Eligibility Criteria
You may qualify if:
- Both sexes.
- ASA grade 1 and 2.
- Age group between 20-60 years.
- Patients who will undergo knee surgeries under neuroaxial anesthesia.
You may not qualify if:
- Patient refusal.
- Patients who are allergic to any of study drugs.
- Absolute contraindication causes to spinal anesthesia due to coagulopathy, severe aortic/mitral stenosis, or active infection at site of injection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of medicine.Beni-suef university
Cairo, 62511, Egypt
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associated Professor of Anesthesiology and Surgical Intensive Care and pain medicine
Study Record Dates
First Submitted
March 2, 2023
First Posted
April 3, 2023
Study Start
April 1, 2023
Primary Completion
December 1, 2023
Study Completion
January 1, 2024
Last Updated
August 19, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share