Clinical trial NCT01840800: USG Nerve Blocks for ACL Reconstruction
Official title: Ultrasound Guided Nerve Block Combinations for Anterior Cruciate Ligament Reconstruction; Femoral, Saphenous and Obturator (Posterior Branch)Nerves.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Keywords: Postoperative pain
anterior cruciate ligament reconstruction
ultrasound guided nerve blocks
opioid consumption
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2013-04-26
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 \[Jensen- Børglum motor test\].


Eligibility 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.

Primary outcomes:
measure: NRS (pain score)
timeFrame: Area under the curve (AUC) 0-6 hours postoperatively
Secondary outcomes:
measure: Opioid consumption
timeFrame: 0-6 hours postoperatively
measure: opioid related side effects
timeFrame: 0-6 hours postoperatively
measure: PACU time
timeFrame: 0-6 hours postoperatively
measure: Motor abilities of of daily living
timeFrame: 0-24 hours postoperatively
measure: Perceived ill health
timeFrame: 0-24 hours postoperatively
measure: Degree of motor block.
timeFrame: 0-6 hours postoperatively
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital, department of anesthesiology
Study officials:
References: