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The goal of this study is to objectify the postoperative pain level, the use of opiates and postoperative nausea and vomiting after adding the adductor canal block to the standard pain regiment after anterior cruciate ligament surgery
Patients scheduled for anterior cruciate ligament surgery will be randomized in an intervention and control group following informed consent.
Before surgery, patients will receive an adductor canal bock with Levobupivacaine (intervention group) or 0.9% saline (control group).
Following surgery, pain intensity, analgesic consumption and pain satisfaction will be recorded bij patients in a diary for 48 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levobupivacaine | Active Comparator | Intervention group; 10 ml of Levobupivacaine 0.25% will be added in the adductor canal using ultrasound |
|
| Placebo | Placebo Comparator | Control group; 10 ml of sodium chloride 0.9% will be added in the adductor canal using ultrasound |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adductor canal block | Procedure | Before anterior cruciate ligament surgery an adductor canal block will be placed using ultrasound. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain level | Using Numerical Rating Scales for pain from 1 to 10, 1 is no pain, 10 is the worst pain you can imagine | Within first 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Opiate use | postoperative use of opiates (Morphine equivalent dose (mg)) | Within first 48 hours after surgery |
| Nausea | Postoperative nausea (yes/no) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leon Timmerman, dr | St. Antonius Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Antonius Ziekenhuis | Nieuwegein | 3435CM | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23788068 | Background | Kwofie MK, Shastri UD, Gadsden JC, Sinha SK, Abrams JH, Xu D, Salviz EA. The effects of ultrasound-guided adductor canal block versus femoral nerve block on quadriceps strength and fall risk: a blinded, randomized trial of volunteers. Reg Anesth Pain Med. 2013 Jul-Aug;38(4):321-5. doi: 10.1097/AAP.0b013e318295df80. | |
| 31980156 | Background |
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Following publication of the results, anonymized IPD (all study results) will be available for meta-analyses upon request.
Following publication of the results, for at least 15 years.
Data will be available on request. If a journal allows online sharing of IPD with a publication, this will be considered as well.
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D000077554 | Levobupivacaine |
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Patients are randomized to receive an intervention (nerve block) with either an active drug or placebo.
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Medication is prepared by study personell not otherwise involved in the study according to a computer generated randomization plan. This plan will be available for analyses after the study. Primary investigator is able to retreive the allocation prematurely if indicated (emergency).
| Levobupivacaine | Drug | Levobupivacaine |
|
| Placebo | Drug | 10 ml of sodium chloride 0.9% |
|
| Within first 48 hours after surgery |
| Block result | If there's any loss of motor function (no quadriceps paresis, partial quadriceps paresis, complete quadriceps paresis.) using bromage score | within first 24 hours after surgery |
| Patient satisfaction | Using Numerical Rating Scales from 1 to 10, 1 is not satisfied at all, 10 is completely satisfied | 48 hours after surgery |
| Johnston DF, Sondekoppam RV, Uppal V, Litchfield R, Giffin R, Ganapathy S. Effect of combining peri-hamstring injection or anterior obturator nerve block on the analgesic efficacy of adductor canal block for anterior cruciate ligament reconstruction: a randomised controlled trial. Br J Anaesth. 2020 Mar;124(3):299-307. doi: 10.1016/j.bja.2019.11.032. Epub 2020 Jan 21. |
| Aniline Compounds |
| D000588 | Amines |