NCT01840800

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 \[Jensen- Børglum motor test\].

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 26, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

July 31, 2014

Status Verified

July 1, 2014

Enrollment Period

1.2 years

First QC Date

February 19, 2013

Last Update Submit

July 30, 2014

Conditions

Pain, Postoperative

Keywords

Postoperative painanterior cruciate ligament reconstructionultrasound guided nerve blocksopioid consumption

Outcome Measures

Primary Outcomes (1)

  • NRS (pain score)

    Numerical rating scale(0-10)

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

Secondary Outcomes (6)

  • Opioid consumption

    0-6 hours postoperatively

  • opioid related side effects

    0-6 hours postoperatively

  • PACU time

    0-6 hours postoperatively

  • Motor abilities of of daily living

    0-24 hours postoperatively

  • Perceived ill health

    0-24 hours postoperatively

  • +1 more secondary outcomes

Study Arms (3)

Active FEM+ONP

ACTIVE COMPARATOR

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 SAPH+ONP

ACTIVE COMPARATOR

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

PLACEBO COMPARATOR

Saline 9 mg/ml

Drug: placebo

Interventions

RopivacaineDRUG
Active FEM+ONPActive SAPH+ONP
placeboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years.
  • Isolated primary ACL reconstruction in general anaesthesia with hamstring graft.
  • ASA 1-3.
  • Written and informed consent to study protocol.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital, department of anesthesiology

Copenhagen, 2400, Denmark

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 19, 2013

First Posted

April 26, 2013

Study Start

February 1, 2013

Primary Completion

May 1, 2014

Study Completion

June 1, 2014

Last Updated

July 31, 2014

Record last verified: 2014-07

Locations

DK(1)