Effect of a Lateral Nerve of the Thigh Block on Postoperative Pain After Total Hip Replacement Surgery
Primary Purpose
Pain, Postoperative, Anesthesia, Conduction, Arthroplasty, Replacement, Hip
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ropivacaine
Placebo
An ultrasound-guided Nervus cutaneous femoral lateralis blockade will be given postoperatively
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring Postoperative pain, regional anaesthesia, total hip replacement, nervus cutaneous femoral lateralis
Eligibility Criteria
Inclusion Criteria:
- Primary total hip replacement
Exclusion Criteria:
- general anaesthesia
- Allergy to local anesthetics of the amide type
- Revision surgery
- Bilateral surgery
- Chronic pain patient
- Women in the fertile age
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ropivacaine
Placebo
Arm Description
8 ml of ropivacaine 7,5 mg/ml will be injected around nervus cutaneous femoral lateralis. Ultrasound-guided.
8 ml of isotonic saline will be injected around nervus cutaneous femoral lateralis. Ultrasound-guided
Outcomes
Primary Outcome Measures
VAS-score 4 hours postoperative during movement
VAS-score 4 hours postoperative during 30 degrees of flexion of the hip. VAS-score: 0-100 mm; 0: no pain, 100: worst imaginable pain.
Secondary Outcome Measures
VAS-score 0-24 hours postoperative during movement
VAS-score 0, 1, 2, 8, 12, and 24 hours postoperative during 30 degrees of flexion of the hip. VAS-score: 0-100 mm; 0: no pain, 100: worst imaginable pain.
VAS-score 0-24 hours postoperative at rest
VAS-score 0, 1, 2, 4, 8, 12, and 24 hours postoperative at rest. VAS-score: 0-100 mm; 0: no pain, 100: worst imaginable pain.
Oxynorm consumption
Oxynorm consumption 24 hours postoperative
time to first oxynorm requirement
Mobilization
time to first mobilization
Mobilization
Ability to mobilize judged by the cumulated ambulation (CAS) score: 0-6; 0 no mobilization, 6: fully mobilized
Length of stay
Full Information
NCT ID
NCT02289937
First Posted
November 10, 2014
Last Updated
November 12, 2014
Sponsor
Daniel Hägi-Pedersen
1. Study Identification
Unique Protocol Identification Number
NCT02289937
Brief Title
Effect of a Lateral Nerve of the Thigh Block on Postoperative Pain After Total Hip Replacement Surgery
Official Title
Effect of a Lateral Nerve of the Thigh Block on Postoperative Pain After Total Hip Replacement Surgery: a Clinical Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Daniel Hägi-Pedersen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study was to evaluate the analgesic efficacy of the nervus cutaneous femoral lateralis (NCFL) blockade on postoperative pain after total hip replacement surgery. The NCFL-block is a pure sensory block. We hypothesized that the NCFL-block would reduced the postoperative pain without delaying mobilization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Anesthesia, Conduction, Arthroplasty, Replacement, Hip
Keywords
Postoperative pain, regional anaesthesia, total hip replacement, nervus cutaneous femoral lateralis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ropivacaine
Arm Type
Experimental
Arm Description
8 ml of ropivacaine 7,5 mg/ml will be injected around nervus cutaneous femoral lateralis. Ultrasound-guided.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
8 ml of isotonic saline will be injected around nervus cutaneous femoral lateralis. Ultrasound-guided
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Naropin
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline, NaCl
Intervention Type
Device
Intervention Name(s)
An ultrasound-guided Nervus cutaneous femoral lateralis blockade will be given postoperatively
Primary Outcome Measure Information:
Title
VAS-score 4 hours postoperative during movement
Description
VAS-score 4 hours postoperative during 30 degrees of flexion of the hip. VAS-score: 0-100 mm; 0: no pain, 100: worst imaginable pain.
Time Frame
4 hours postoperative
Secondary Outcome Measure Information:
Title
VAS-score 0-24 hours postoperative during movement
Description
VAS-score 0, 1, 2, 8, 12, and 24 hours postoperative during 30 degrees of flexion of the hip. VAS-score: 0-100 mm; 0: no pain, 100: worst imaginable pain.
Time Frame
0-24 hours postoperatively
Title
VAS-score 0-24 hours postoperative at rest
Description
VAS-score 0, 1, 2, 4, 8, 12, and 24 hours postoperative at rest. VAS-score: 0-100 mm; 0: no pain, 100: worst imaginable pain.
Time Frame
0-24 hours postoperatively
Title
Oxynorm consumption
Description
Oxynorm consumption 24 hours postoperative
Time Frame
0-24 hours postoperative
Title
time to first oxynorm requirement
Time Frame
0-24 hours postoperatively
Title
Mobilization
Description
time to first mobilization
Time Frame
0-24 hours postoperatively
Title
Mobilization
Description
Ability to mobilize judged by the cumulated ambulation (CAS) score: 0-6; 0 no mobilization, 6: fully mobilized
Time Frame
0-24 hours postoperatively
Title
Length of stay
Time Frame
0-7 days postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Primary total hip replacement
Exclusion Criteria:
general anaesthesia
Allergy to local anesthetics of the amide type
Revision surgery
Bilateral surgery
Chronic pain patient
Women in the fertile age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Hägi-Pedersen, M.D., Ph.D.
Organizational Affiliation
Naestved Hospital, Department of Anaesthesiology
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Effect of a Lateral Nerve of the Thigh Block on Postoperative Pain After Total Hip Replacement Surgery
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