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USG Nerve Blocks for ACL Reconstruction

NCT ID: NCT01840800

Last Updated: 2014-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2014-06-30

Brief Summary

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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

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Conditions

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Pain, Postoperative

Keywords

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Postoperative pain anterior cruciate ligament reconstruction ultrasound guided nerve blocks opioid consumption

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

Placebo

Saline 9 mg/ml

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

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Ropivacaine

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jens Borglum Neimann

OTHER

Sponsor Role lead

Responsible Party

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Jens Borglum Neimann

Associate professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Bispebjerg Hospital, department of anesthesiology

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-2-2012-063

Identifier Type: -

Identifier Source: org_study_id