USG Nerve Blocks for ACL Reconstruction

Study Overview
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Brief Summary
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Anterior cruciate ligament reconstruction is a routine surgical procedure. Traditional femoral/sciatic block combinations effectively reduce postoperative pain, but results in considerable motor blockade. The investigators aimed to evaluate postoperative pain relief and the degree of motor block with block combinations of femoral nerve (FEM) and obturator [posterior branch] nerve (ONP), versus saphenous nerve (SAPH) and ONP, versus placebo blocks with isotonic saline. All patients received standard patient controlled analgesia with morphine.Randomized, placebo-controlled and double-blinded clinical trial. Following IRB approval, 81 patients were planned to be randomized to one of three USG block combinations: Active FEM+ONP, active SAPH+ONP or no active blocks (sham blocks) Ropivacaine 0.75% was used for all active blocks following induction of general anaesthesia [propofol-remifentanil, laryngeal mask airway]. Primary outcome measure: Localized PACU pain scores (AUC) 0-6 hours postoperatively at rest. Secondary outcome measures: Opioid consumption, opioid related side effects, PACU time, motor abilities of daily living scores [modified Barthel/100 index], perceived ill health [Short form-8] scores and degree of motor blockade [Jensen- Børglum motor test].

Official Title
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Ultrasound Guided Nerve Block Combinations for Anterior Cruciate Ligament Reconstruction; Femoral, Saphenous and Obturator (Posterior Branch)Nerves.

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Ropivacaine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years. Isolated primary ACL reconstruction in general anaesthesia with hamstring graft. ASA 1-3. Written and informed consent to study protocol. Exclusion Criteria: ACL reconstruction with patellar tendon graft Uncooperative patients. Patients that do not understand or speak danish. Daily use of opioids equivalent to > 40 mg morphine. Allergic to Ropivacaine. Alcohol abusers Contraindications to general anaesthesia. Pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active FEM+ONP<br>Nerveblock of n. femoralis (FEM) with 10 ml Ropivacaine 7.5 mg/ml and nerveblock of obturator nerveposterior branch (ONP) with 10 ml Ropivacaine 7.5 mg/ml. | Drug: Ropivacaine<br> <br> |
| Active Comparator: Active SAPH+ONP<br>Nerveblock of n.saphenous (SAPH) with 5 ml Ropivacaine 7.5 mg/ml and nerveblock of obturator nerve, posterior branch (ONP) with 10 ml Ropivacaine 7.5 mg/ml | Drug: Ropivacaine<br> <br> |
| Placebo Comparator: Placebo<br>Saline 9 mg/ml | Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS (pain score) | Numerical rating scale(0-10) | Area under the curve (AUC) 0-6 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption | Opioid consumption (PCA pump - mg of morphine) | 0-6 hours postoperatively | 
| opioid related side effects | Nausea (0-3), vomiting (>10 ml) | 0-6 hours postoperatively | 
| PACU time | Minutes in PACU | 0-6 hours postoperatively | 
| Motor abilities of of daily living | Modified Barthel/100 index | 0-24 hours postoperatively | 
| Perceived ill health | Short-Form-8 | 0-24 hours postoperatively | 
| Degree of motor block. | Jensen-Borglum motor test | 0-6 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative pain, anterior cruciate ligament reconstruction, ultrasound guided nerve blocks, opioid consumption