TIPACK: IPACK or Selective Tibial Nerve Block for ACL Reconstruction With an Adductor Canal Block

Sponsor

Centre Hospitalier Universitaire Vaudois (Other)

Overall Status

Recruiting

CT.gov ID

NCT05303233

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the analgesic efficacy of the combination of an adductor canal and selective tibial nerve blocks versus adductor canal block and IPACK after ACL reconstruction under general anaesthesia.

Condition or Disease	Intervention/Treatment	Phase
Analgesia	Procedure: Selective tibial nerve block Procedure: IPACK	N/A

Detailed Description

The hypothesis of this study is that a combined adductor canal and selective tibial nerve block provides better analgesia than a combined adductor canal block and IPACK in patients undergoing anterior cruciate ligament reconstruction.

This randomized controlled trial will include two groups: an adductor canal block plus IPACK group (group IPACK) and an adductor canal block plus tibial selective nerve block group (group TIBIAL). After written informed consent, patients will be allocated to one of the groups, following a computer-generated list of randomization.

Prior to surgery, all patients will have an adductor canal block with 20ml of ropivacaine 0.75%. In group TIBIAL the patient will receive in addition a selective tibial nerve block with 5 ml of ropivacaine 0.75%. In group IPACK the patient will receive in addition an IPACK with 20ml of ropivacaine 0.2%. In both groups, patients will have the surgery under general anaesthesia with a multimodal analgesic regimen inclusive of iv dexamethasone 8 mg, iv magnesium sulfate 40 mg.kg-1, iv ketorolac 30 mg, and iv acetaminophen 1000 mg.

After surgery, all patients will be prescribed an iv patient-controlled analgesia (PCA) of morphine (boluses of 2 mg available every 10 min, maximum of 40 mg every 4 hours) along with oral acetaminophen (1000 mg every 6 h) and oral ibuprofen (400 mg every 8 hours). Oral ondansetron 4 mg every 8 hours will be available on request in case of nausea or vomiting.

The primary outcome will be the cumulative iv morphine consumption at 24 h postoperatively. Secondary outcomes will include pain- and functional-related outcomes. Pain-related outcomes include cumulative morphine consumption at 2h and 48h postoperatively, rest and dynamic pain scores and rate of PONV at 2 h, 24 h and 48 h postoperatively. Early functional-related outcomes include range of motion, strength and walking distance at 24 h and 48 h postoperatively. Late functional-related outcomes include range of motion, strength, hop distance, agility test, Y balance test, Anterior Cruciate Ligament Return to Sport After Injury Scale (ACL-RSI) and International Knee Documentation Committee Scale (IKDC) at 4 and 8 months postoperatively.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Analgesic Efficacy of IPACK Versus Selective Tibial Nerve Block in Patients Scheduled for Anterior Cruciate Ligament Reconstruction Under General Anaesthesia With an Adductor Canal Block: a Randomized Controlled Double-blinded Trial

Actual Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

May 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TIBIAL group All patients allocated to the TIBIAL group will receive an adductor canal block with 20ml of ropivacaine 0.75% and a selective tibial nerve block with 5 ml of ropivacaine 0.75% prior to surgery,	Procedure: Selective tibial nerve block The selective tibial nerve block will be performed on the popliteal crease following sterilization of the area. The probe will be placed in a transverse position at the popliteal crease to visualize the popliteal artery and the tibial nerve in short axis. A 21-gauge 50mm insulated facet tip needle (SonoPlex® STIM, Pajunk, Geisingen, DE) will be inserted in-plane with the ultrasound bean from a medial to lateral direction. Once the needle tip is adjacent to the tibial nerve, 5 ml of ropivacaine 0.75% will be injected to achieve an adequate spread of local anaesthetics around the nerve.
Active Comparator: IPACK group All patients allocated to the IPACK group will receive an adductor canal block with 20ml of ropivacaine 0.75% and an IPACK with 20ml of ropivacaine 0.2% prior to surgery.	Procedure: IPACK The IPACK will be performed on the popliteal crease following sterilization of the area. The probe will be placed in a transverse position proximal to the popliteal crease to visualize the popliteal artery in short axis. A 21-gauge 100 mm insulated facet tip needle (SonoPlex® STIM, Pajunk, Geisingen, DE) will be inserted in-plane with the ultrasound beam, in a lateral to medial direction, between the popliteal artery and the posterior capsule, where twenty mL of ropivacaine 0.2% will be injected under ultrasound guidance. The distribution of local anaesthetics will be observed above the posterior capsule.

Arm

Intervention/Treatment

Experimental: TIBIAL group

All patients allocated to the TIBIAL group will receive an adductor canal block with 20ml of ropivacaine 0.75% and a selective tibial nerve block with 5 ml of ropivacaine 0.75% prior to surgery,

Procedure: Selective tibial nerve block

The selective tibial nerve block will be performed on the popliteal crease following sterilization of the area. The probe will be placed in a transverse position at the popliteal crease to visualize the popliteal artery and the tibial nerve in short axis. A 21-gauge 50mm insulated facet tip needle (SonoPlex® STIM, Pajunk, Geisingen, DE) will be inserted in-plane with the ultrasound bean from a medial to lateral direction. Once the needle tip is adjacent to the tibial nerve, 5 ml of ropivacaine 0.75% will be injected to achieve an adequate spread of local anaesthetics around the nerve.

Active Comparator: IPACK group

All patients allocated to the IPACK group will receive an adductor canal block with 20ml of ropivacaine 0.75% and an IPACK with 20ml of ropivacaine 0.2% prior to surgery.

Procedure: IPACK

The IPACK will be performed on the popliteal crease following sterilization of the area. The probe will be placed in a transverse position proximal to the popliteal crease to visualize the popliteal artery in short axis. A 21-gauge 100 mm insulated facet tip needle (SonoPlex® STIM, Pajunk, Geisingen, DE) will be inserted in-plane with the ultrasound beam, in a lateral to medial direction, between the popliteal artery and the posterior capsule, where twenty mL of ropivacaine 0.2% will be injected under ultrasound guidance. The distribution of local anaesthetics will be observed above the posterior capsule.

Outcome Measures

Primary Outcome Measures

Total intravenous morphine consumption [1 day postoperatively]
Consumption in mg

Secondary Outcome Measures

Total intravenous morphine consumption [2 hours and 2 days postoperatively]
Consumption in mg
Resting and dynamic pain score [2 hours, 1 day and 2 days postoperatively]
Numeric Rating Scale (NRS), 0-10 where 0 is no pain and 10 is the worst pain imaginable
Incidence of postoperative nausea and vomiting [2 hours, 1 day and 2 days postoperatively]
Presence of nausea and vomiting in the postoperative period
Range of motion [1 day and 2 days postoperatively]
Joint motion in degrees
Quadriceps strength [1 day and 2 days postoperatively]
Ordinal scale of 1-5, with 5 being the maximal developed strength compared with the opposite side
Walking distance [1 day and 2 days postoperatively]
Distance in meters
Range of motion [4 months and 8 months postoperatively]
Joint motion in degrees
Concentric quadriceps strength and concentric hamstring strength [4 months and 8 months postoperatively]
Percentage of strength as compared with the opposite leg
Single hop distance, triple hop distance and crossover triple hop distance [4 months and 8 months postoperatively]
Percentage of distance as compared with the opposite leg
Agility test [4 months and 8 months postoperatively]
Time in second
Y balance test [4 months and 8 months postoperatively]
Distance in cm
Anterior Cruciate Ligament Return to Sport After Injury Scale score [4 months and 8 months postoperatively]
Score in percentage
International Knee Documentation Committee Scale score [4 months and 8 months postoperatively]
Score in percentage

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

ASA score I-III
18 years or older
Scheduled for elective primary ACL reconstruction
Signature of consent form

Exclusion Criteria:

Refusal or inability for informed consent
Known allergies to ropivacaine, acetaminophen, ibuprofen, ketorolac, morphine, sufentanyl, ondansetron or dexamethason
Secondary surgical revision
Opioid treatment such as morphine, hydrocodone, hydromorphone, tramadol, methadone, fentanyl, buprenorphine or codeine
Bleeding diathesis
Neurological deficit
Known renal insufficiency (eGFR <45 ml/min)
Known hepatic insufficiency (Child score B or C)
Pregnancy or lactating
Alcohol abuse