Clinical trial NCT05303233: IPACK or Selective Tibial Nerve Block for ACL Reconstruction with an Adductor Canal Block
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Analgesia
Keywords: Regional anesthesia
Selective tibial nerve block
IPACK
Anterior cruciate ligament reconstruction
Multimodal analgesia
Local anesthetics
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total intravenous morphine consumption
timeFrame: 1 day postoperatively
Secondary outcomes:
measure: Total intravenous morphine consumption
timeFrame: 2 hours and 2 days postoperatively
measure: Resting and dynamic pain score
timeFrame: 2 hours, 1 day and 2 days postoperatively
measure: Incidence of postoperative nausea and vomiting
timeFrame: 2 hours, 1 day and 2 days postoperatively
measure: Range of motion
timeFrame: 1 day and 2 days postoperatively
measure: Quadriceps strength
timeFrame: 1 day and 2 days postoperatively
measure: Walking distance
timeFrame: 1 day and 2 days postoperatively
measure: Range of motion
timeFrame: 4 months and 8 months postoperatively
measure: Concentric quadriceps strength and concentric hamstring strength
timeFrame: 4 months and 8 months postoperatively
measure: Single hop distance, triple hop distance and crossover triple hop distance
timeFrame: 4 months and 8 months postoperatively
measure: Agility test
timeFrame: 4 months and 8 months postoperatively
measure: Y balance test
timeFrame: 4 months and 8 months postoperatively
measure: Anterior Cruciate Ligament Return to Sport After Injury Scale score
timeFrame: 4 months and 8 months postoperatively
measure: International Knee Documentation Committee Scale score
timeFrame: 4 months and 8 months postoperatively
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: University Hospital of Lausanne
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois
name: Eric Albrecht, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chuaychoosakoon C, Parinyakhup W, Wiwatboworn A, Purngpiputtrakul P, Wanasitchaiwat P, Boonriong T. Comparing post-operative pain between single bundle and double bundle anterior cruciate ligament reconstruction: a retrospective study. BMC Musculoskelet Disord. 2021 Sep 3;22(1):753. doi: 10.1186/s12891-021-04635-5.
citation: Smith JH, Belk JW, Kraeutler MJ, Houck DA, Scillia AJ, McCarty EC. Adductor Canal Versus Femoral Nerve Block after Anterior Cruciate Ligament Reconstruction: A Systematic Review of Level I Randomized Controlled Trials Comparing Early Postoperative Pain, Opioid Requirements, and Quadriceps Strength. Arthroscopy. 2020 Jul;36(7):1973-1980. doi: 10.1016/j.arthro.2020.03.040. Epub 2020 Apr 18.
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citation: Silverman ER, Vydyanathan A, Gritsenko K, Shaparin N, Singh N, Downie SA, Kosharskyy B. The Anatomic Relationship of the Tibial Nerve to the Common Peroneal Nerve in the Popliteal Fossa: Implications for Selective Tibial Nerve Block in Total Knee Arthroplasty. Pain Res Manag. 2017;2017:7250181. doi: 10.1155/2017/7250181. Epub 2017 Feb 2.
citation: Stebler K, Martin R, Kirkham KR, Lambert J, De Sede A, Albrecht E. Adductor canal block versus local infiltration analgesia for postoperative pain after anterior cruciate ligament reconstruction: a single centre randomised controlled triple-blinded trial. Br J Anaesth. 2019 Aug;123(2):e343-e349. doi: 10.1016/j.bja.2019.04.053. Epub 2019 May 24.
citation: Martin R, Kirkham KR, Ngo THN, Gonvers E, Lambert J, Albrecht E. Combination of femoral triangle block and infiltration between the popliteal artery and the capsule of the posterior knee (iPACK) versus local infiltration analgesia for analgesia after anterior cruciate ligament reconstruction: a randomized controlled triple-blinded trial. Reg Anesth Pain Med. 2021 Sep;46(9):763-768. doi: 10.1136/rapm-2021-102631. Epub 2021 May 26.
citation: van der Wal M, Lang SA, Yip RW. Transsartorial approach for saphenous nerve block. Can J Anaesth. 1993 Jun;40(6):542-6. doi: 10.1007/BF03009739.