USG Nerve Blocks for ACL Reconstruction

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

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].

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: placebo; Drug: Ropivacaine

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2400
    • Bispebjerg Hospital, department of anesthesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS (pain score)	Numerical rating scale(0-10)	Area under the curve (AUC) 0-6 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption	Opioid consumption (PCA pump - mg of morphine)	0-6 hours postoperatively
opioid related side effects	Nausea (0-3), vomiting (>10 ml)	0-6 hours postoperatively
PACU time	Minutes in PACU	0-6 hours postoperatively
Motor abilities of of daily living	Modified Barthel/100 index	0-24 hours postoperatively
Perceived ill health	Short-Form-8	0-24 hours postoperatively
Degree of motor block.	Jensen-Borglum motor test	0-6 hours postoperatively

Collaborators and Investigators

• Sponsor: Jens Borglum Neimann

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: February 19, 2013
• First Submitted That Met QC Criteria: April 25, 2013
• First Posted (Estimate): April 26, 2013

Study Record Updates

• Last Update Posted (Estimate): July 31, 2014
• Last Update Submitted That Met QC Criteria: July 30, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Postoperative pain; opioid consumption; anterior cruciate ligament reconstruction; ultrasound guided nerve blocks
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: H-2-2012-063