- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05269095
Adductor Canal Block Combined With IPACK vs Genicular Nerves Block in Knee Arthroscopy
Analgesic Effect of Adductor Canal Block Combined With Infiltration of the Interspace Between Popliteal Artery and the Capsule of the Knee (IPACK) Block Versus Genicular Nerves Block in Knee Arthroscopy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Maintaining patient safety, ensuring best patient outcomes, and optimal pain relief post-operatively are of utmost concern for anesthesia providers. Adequate pain relief attenuates stress responses and long-term chronic pain complications while contributing to improved postoperative outcomes.
Knee arthroscopy is a very common procedure and very often is performed as day-case surgery. Ambulatory arthroscopic surgery of the knee is preferred by the majority of properly selected and well-informed patients. It has been reported that a significant number of patients have moderate to severe pain 24 hours after ambulatory surgery in general and knee arthroscopy in particular and pain affects the patient's activity level and satisfaction. Adductor canal block (ACB) is a popular peripheral nerve block that has been shown to decrease the pain significantly and decrease opioid consumption with minimal effect on quadriceps function. It provides analgesia to the peri-articular and intra-articular aspects of the knee joint but doesn't relieve posterior knee pain which is moderate to severe in intensity.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 21-60 years
- Both genders
- American Society of Anaesthesiologists physical status classification I - III
- Patients scheduled for elective unilateral knee arthroscopy under spinal anesthesia
Exclusion Criteria:
- Patient refusal
- Preoperative neurological deficits
- Opioid-dependent (opioid intake more than 3 months)
- Chronic pain conditions
- Significant cardiac and respiratory disease
- Pre-existing major organ dysfunction such as hepatic and renal failure
- Coexisting hematological disorder or deranged coagulation parameters
- Psychiatric illnesses
- Allergy to any of the drugs used in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: spinal anesthesia only
Patients will receive spinal anesthesia only
|
Patients will receive spinal anesthesia with 2-3 ml 0.5% (10-15 mg) hyperbaric bupivacaine plus 25 ug fentanyl at the L3/4 interspaces.
|
|
Experimental: spinal anesthesia and ultrasound-guided Genicular nerves block
Patients will receive spinal anesthesia and ultrasound-guided Genicular nerves block
|
Patients will receive16 ml bupivacaine 0025% will be administered, and4 ml of this solution will be placed at each of the 4 target nerves.
|
|
Experimental: Spinal anesthesia and US guided Adductor canal nerve block plus infiltration of the interspace
Patients will receive spinal anesthesia and ultrasound-guided Adductor canal nerve block plus infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (PACK) block.
|
Adductor Canal block (ACB) technique will be performed using 16 ml bupivacaine 0025% As regarding the Popliteal artery and the capsule of posterior knee block ('PACK), it will be performed Using 16 ml bupivacaine 0.25%
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative 24-hour rescue analgesic consumption
Time Frame: 24 hours postoperative
|
Total postoperative 24-hour rescue analgesic consumption will be recorded
|
24 hours postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-operative pain
Time Frame: 24 hours Postoperative
|
Post-operative pain will be assessed by the Numeric Rating Scale (NRS) rest and mobilization.
|
24 hours Postoperative
|
|
Time taken till 1st rescue analgesic request
Time Frame: 24 hours Postoperative
|
The time till administration of first rescue analgesia will be recorded
|
24 hours Postoperative
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 35236/1/22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Arthroscopy
-
Pfizer's Upjohn has merged with Mylan to form Viatris...Completed
-
University Hospital, Strasbourg, FranceRecruiting
-
Peking University Third HospitalCompleted
-
University of OxfordCompleted
-
NYU Langone HealthCompletedHip ArthroscopyUnited States
-
Sheba Medical CenterWithdrawn
-
Cedars-Sinai Medical CenterWithdrawnKnee Arthroscopy | Shoulder ArthroscopyUnited States
-
St. Luke's Hospital, PennsylvaniaCompletedVisualization in Shoulder ArthroscopyUnited States
-
McMaster UniversityHamilton Health Sciences Corporation; The Physicians' Services Incorporated...CompletedKnee Arthroscopy | Shoulder ArthroscopyCanada
-
Smith & Nephew, Inc.Completed
Clinical Trials on Spinal anesthesia only
-
MEHMET GÖKHAN TAFLANRecruitingPostoperative Pain Management | Recovery From Anesthesia | Obstetric AnesthesiaTurkey (Türkiye)
-
Liaquat National Hospital & Medical CollegeNot yet recruitingHypotension After Spinal AnesthesiaPakistan
-
Gaziantep City HospitalNot yet recruiting
-
Tanta UniversityCompletedSpinal Anesthesia | General Anesthesia | Adults | Cystoscope | Penile LengthEgypt
-
Adiyaman University Research HospitalNot yet recruiting
-
Military Hospital of TunisCompletedSpinal Anesthesia | Ultrasound Guidance | Procedural Performance | Conventional Palpation TechniqueTunisia
-
CMH Lahore Medical College and Institute of DentistryActive, not recruitingSubarachnoid Block | Adjuvants, AnesthesiaPakistan
-
Ankara Etlik City HospitalCompletedSpinal Anesthesia | Ambulatory Surgery | Femoral Nerve Block | Discharge TimeTurkey (Türkiye)
-
Amr mohamedNot yet recruiting
-
Bangladesh Medical UniversityCompleted"Ultrasound vs. Landmark Technique for Spinal Anesthesia in Obese Women Undergoing Cesarean Section"Cesarean Section | Obese Parturient | Ultrasound Guided Subarachnoid BlockBangladesh