USG Nerve Blocks for ACL Reconstruction
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Ropivacaine
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring Postoperative pain, anterior cruciate ligament reconstruction, ultrasound guided nerve blocks, opioid consumption
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.
Sites / Locations
- Bispebjerg Hospital, department of anesthesiology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Active FEM+ONP
Active SAPH+ONP
Placebo
Arm Description
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.
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
Saline 9 mg/ml
Outcomes
Primary Outcome Measures
NRS (pain score)
Numerical rating scale(0-10)
Secondary Outcome Measures
Opioid consumption
Opioid consumption (PCA pump - mg of morphine)
opioid related side effects
Nausea (0-3), vomiting (>10 ml)
PACU time
Minutes in PACU
Motor abilities of of daily living
Modified Barthel/100 index
Perceived ill health
Short-Form-8
Degree of motor block.
Jensen-Borglum motor test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01840800
Brief Title
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
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jens Borglum Neimann
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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].
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Postoperative pain, anterior cruciate ligament reconstruction, ultrasound guided nerve blocks, opioid consumption
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active FEM+ONP
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Active SAPH+ONP
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline 9 mg/ml
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
NRS (pain score)
Description
Numerical rating scale(0-10)
Time Frame
Area under the curve (AUC) 0-6 hours postoperatively
Secondary Outcome Measure Information:
Title
Opioid consumption
Description
Opioid consumption (PCA pump - mg of morphine)
Time Frame
0-6 hours postoperatively
Title
opioid related side effects
Description
Nausea (0-3), vomiting (>10 ml)
Time Frame
0-6 hours postoperatively
Title
PACU time
Description
Minutes in PACU
Time Frame
0-6 hours postoperatively
Title
Motor abilities of of daily living
Description
Modified Barthel/100 index
Time Frame
0-24 hours postoperatively
Title
Perceived ill health
Description
Short-Form-8
Time Frame
0-24 hours postoperatively
Title
Degree of motor block.
Description
Jensen-Borglum motor test
Time Frame
0-6 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Bispebjerg Hospital, department of anesthesiology
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
12. IPD Sharing Statement
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USG Nerve Blocks for ACL Reconstruction
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