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OpenTrials
Completed

NCT Number: NCT01840800

USG Nerve Blocks for ACL Reconstruction

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].

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg Hospital, department of anesthesiology

Copenhagen, 2400, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ropivacaine

Drug

Placebo

Drug

Primary outcomes

  1. NRS (pain score)

    Time frame: Area under the curve (AUC) 0-6 hours postoperatively

    Numerical rating scale(0-10)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Jens Borglum Neimann

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 26, 2013
Registry last updated
Jul 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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