USG Nerve Blocks for ACL Reconstruction

Not Applicable

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: placebo; Drug: Ropivacaine

• Registration Number: NCT01840800
• Lead Sponsor: Jens Borglum Neimann

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 \[Jensen- Børglum motor test\].

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-19
• Study First Submitted QC: 2013-04-25
• Study First Posted: 2013-04-26
• Primary Completion: 2014-05
• Study Completion: 2014-06
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-30
• Last Update Posted: 2014-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Saline 9 mg/ml
Active SAPH+ONP	Ropivacaine	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
Active FEM+ONP	Ropivacaine	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.

Primary Outcome Measures

Name	Time	Method
NRS (pain score)	Area under the curve (AUC) 0-6 hours postoperatively	Numerical rating scale(0-10)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bispebjerg Hospital, department of anesthesiology; 🇩🇰 Copenhagen, Denmark