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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
Sponsor:
Information provided by (Responsible Party):
Jens Borglum Neimann, Bispebjerg Hospital

Study Description
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Brief Summary:

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 Design
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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

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Arms and Interventions
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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
 Drug: Ropivacaine
Placebo Comparator: Placebo
Saline 9 mg/ml
 Drug: placebo


Outcome Measures
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Primary Outcome Measures :
  1. NRS (pain score) [ Time Frame: Area under the curve (AUC) 0-6 hours postoperatively ]
    Numerical rating scale(0-10)


Secondary Outcome Measures :
  1. Opioid consumption [ Time Frame: 0-6 hours postoperatively ]
    Opioid consumption (PCA pump - mg of morphine)

  2. opioid related side effects [ Time Frame: 0-6 hours postoperatively ]
    Nausea (0-3), vomiting (>10 ml)

  3. PACU time [ Time Frame: 0-6 hours postoperatively ]
    Minutes in PACU

  4. Motor abilities of of daily living [ Time Frame: 0-24 hours postoperatively ]
    Modified Barthel/100 index

  5. Perceived ill health [ Time Frame: 0-24 hours postoperatively ]
    Short-Form-8

  6. Degree of motor block. [ Time Frame: 0-6 hours postoperatively ]
    Jensen-Borglum motor test


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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


Locations
Denmark
Bispebjerg Hospital, department of anesthesiology
Copenhagen, Denmark, 2400
Sponsors and Collaborators
Jens Borglum Neimann
More Information
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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