IPACK or Selective Tibial Nerve Block for ACL Reconstruction with an Adductor Canal Block
- Conditions
- Analgesia
- Interventions
- Procedure: IPACKProcedure: Selective tibial nerve block
- Registration Number
- NCT05303233
- Lead Sponsor
- Centre Hospitalier Universitaire Vaudois
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 80
- ASA score I-III
- 18 years or older
- Scheduled for elective primary ACL reconstruction
- Signature of consent form
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IPACK group IPACK 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. TIBIAL group Selective tibial nerve block 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,
- Primary Outcome Measures
Name Time Method Total intravenous morphine consumption 1 day postoperatively Consumption in mg
- Secondary Outcome Measures
Name Time Method Range of motion 4 months and 8 months postoperatively Joint motion in degrees
Incidence of postoperative nausea and vomiting 2 hours, 1 day and 2 days postoperatively Presence of nausea and vomiting in the postoperative period
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
Walking distance 1 day and 2 days postoperatively Distance in meters
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
Y balance test 4 months and 8 months postoperatively Distance in cm
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
Concentric quadriceps strength and concentric hamstring strength 4 months and 8 months postoperatively Percentage of strength as compared with the opposite leg
International Knee Documentation Committee Scale score 4 months and 8 months postoperatively Score in percentage
Agility test 4 months and 8 months postoperatively Time in second
Anterior Cruciate Ligament Return to Sport After Injury Scale score 4 months and 8 months postoperatively Score in percentage
Trial Locations
- Locations (1)
University Hospital of Lausanne
🇨🇭Lausanne, Switzerland