USG Nerve Blocks for ACL Reconstruction
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ClinicalTrials.gov Identifier: NCT01840800 |
Recruitment Status
:
Completed
First Posted
: April 26, 2013
Last Update Posted
: July 31, 2014
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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].
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pain, Postoperative | Drug: Ropivacaine Drug: placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 82 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Ultrasound Guided Nerve Block Combinations for Anterior Cruciate Ligament Reconstruction; Femoral, Saphenous and Obturator (Posterior Branch)Nerves. |
Study Start Date : | February 2013 |
Actual Primary Completion Date : | May 2014 |
Actual Study Completion Date : | June 2014 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Active FEM+ONP
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 |
Active Comparator: Active SAPH+ONP
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
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Drug: Ropivacaine |
Placebo Comparator: Placebo
Saline 9 mg/ml
|
Drug: placebo |
- NRS (pain score) [ Time Frame: Area under the curve (AUC) 0-6 hours postoperatively ]Numerical rating scale(0-10)
- Opioid consumption [ Time Frame: 0-6 hours postoperatively ]Opioid consumption (PCA pump - mg of morphine)
- opioid related side effects [ Time Frame: 0-6 hours postoperatively ]Nausea (0-3), vomiting (>10 ml)
- PACU time [ Time Frame: 0-6 hours postoperatively ]Minutes in PACU
- Motor abilities of of daily living [ Time Frame: 0-24 hours postoperatively ]Modified Barthel/100 index
- Perceived ill health [ Time Frame: 0-24 hours postoperatively ]Short-Form-8
- Degree of motor block. [ Time Frame: 0-6 hours postoperatively ]Jensen-Borglum motor test

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01840800
Denmark | |
Bispebjerg Hospital, department of anesthesiology | |
Copenhagen, Denmark, 2400 |
Responsible Party: | Jens Borglum Neimann, Associate professor, Bispebjerg Hospital |
ClinicalTrials.gov Identifier: | NCT01840800 History of Changes |
Other Study ID Numbers: |
H-2-2012-063 |
First Posted: | April 26, 2013 Key Record Dates |
Last Update Posted: | July 31, 2014 |
Last Verified: | July 2014 |
Keywords provided by Jens Borglum Neimann, Bispebjerg Hospital:
Postoperative pain anterior cruciate ligament reconstruction ultrasound guided nerve blocks opioid consumption |
Additional relevant MeSH terms:
Pain, Postoperative Pain Neurologic Manifestations Nervous System Diseases Postoperative Complications Pathologic Processes Signs and Symptoms |
Ropivacaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |