Adductor Canal Block Combined With IPACK vs Genicular Nerves Block in Knee Arthroscopy

Sponsor

Tanta University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05269095

Collaborator

(none)

105

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This prospective randomized controlled study is designed to investigate the postoperative analgesic effect of adductor canal block (ACB) combined with infiltration of the interspace between the popliteal artery and the capsule of posterior knee (IPACK) block compared to genicular nerves block in patients undergoing knee arthroscopy.

Condition or Disease	Intervention/Treatment	Phase
Arthroscopy Genicular Nerves Block	Procedure: Spinal anesthesia only Biological: Spinal anesthesia and ultrasound-guided Genicular nerves block Biological: Ultrasound-guided Adductor Canal block (ACB) technique with infiltration of the interspace between popliteal artery and the capsule of posterior knee block ('PACK)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

105 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 21, 2022

Anticipated Primary Completion Date :

Mar 20, 2023

Anticipated Study Completion Date :

Mar 21, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: spinal anesthesia only Patients will receive spinal anesthesia only	Procedure: 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	Biological: 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.	Biological: Ultrasound-guided Adductor Canal block (ACB) technique with infiltration of the interspace between popliteal artery and the capsule of posterior knee block ('PACK) 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%

Arm

Intervention/Treatment

Experimental: spinal anesthesia only

Patients will receive spinal anesthesia only

Procedure: 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

Biological: 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.

Biological: Ultrasound-guided Adductor Canal block (ACB) technique with infiltration of the interspace between popliteal artery and the capsule of posterior knee block ('PACK)

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%

Outcome Measures

Primary Outcome Measures

Postoperative 24-hour rescue analgesic consumption [24 hours postoperative]
Total postoperative 24-hour rescue analgesic consumption will be recorded

Secondary Outcome Measures

Post-operative pain [24 hours Postoperative]
Post-operative pain will be assessed by the Numeric Rating Scale (NRS) rest and mobilization.
Time taken till 1st rescue analgesic request [24 hours Postoperative]
The time till administration of first rescue analgesia will be recorded

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Muhammad Ahmed Kandil, Resident of Anesthesiology and Surgical Intensive Care and Pain Medicine, Tanta University

ClinicalTrials.gov Identifier:

NCT05269095

Other Study ID Numbers:

35236/1/22

First Posted:

Mar 7, 2022

Last Update Posted:

Mar 24, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anesthetics

Study Results

No Results Posted as of Mar 24, 2022