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USG Nerve Blocks for ACL Reconstruction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jens Borglum Neimann, Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT01840800
First received: February 19, 2013
Last updated: July 30, 2014
Last verified: July 2014
  Purpose

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 Intervention
Pain, Postoperative
Drug: Ropivacaine
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • NRS (pain score) [ Time Frame: Area under the curve (AUC) 0-6 hours postoperatively ] [ Designated as safety issue: No ]
    Numerical rating scale(0-10)


Secondary Outcome Measures:
  • Opioid consumption [ Time Frame: 0-6 hours postoperatively ] [ Designated as safety issue: No ]
    Opioid consumption (PCA pump - mg of morphine)

  • opioid related side effects [ Time Frame: 0-6 hours postoperatively ] [ Designated as safety issue: No ]
    Nausea (0-3), vomiting (>10 ml)

  • PACU time [ Time Frame: 0-6 hours postoperatively ] [ Designated as safety issue: No ]
    Minutes in PACU

  • Motor abilities of of daily living [ Time Frame: 0-24 hours postoperatively ] [ Designated as safety issue: No ]
    Modified Barthel/100 index

  • Perceived ill health [ Time Frame: 0-24 hours postoperatively ] [ Designated as safety issue: No ]
    Short-Form-8

  • Degree of motor block. [ Time Frame: 0-6 hours postoperatively ] [ Designated as safety issue: No ]
    Jensen-Borglum motor test


Enrollment: 82
Study Start Date: February 2013
Study Completion Date: June 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01840800

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

No publications provided

Responsible Party: Jens Borglum Neimann, Associate professor, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01840800     History of Changes
Other Study ID Numbers: H-2-2012-063
Study First Received: February 19, 2013
Last Updated: July 30, 2014
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Bispebjerg Hospital:
Postoperative pain
anterior cruciate ligament reconstruction
ultrasound guided nerve blocks
opioid consumption

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Ropivacaine
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014