Effect of a Lateral Nerve of the Thigh Block on Postoperative Pain After Total Hip Replacement Surgery
2 other identifiers
interventional
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2014
Shorter than P25 for phase_4
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
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 10, 2014
CompletedFirst Posted
Study publicly available on registry
November 13, 2014
CompletedNovember 13, 2014
November 1, 2014
7 months
November 10, 2014
November 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
4 hours postoperative
Secondary Outcomes (7)
VAS-score 0-24 hours postoperative during movement
0-24 hours postoperatively
VAS-score 0-24 hours postoperative at rest
0-24 hours postoperatively
Oxynorm consumption
0-24 hours postoperative
time to first oxynorm requirement
0-24 hours postoperatively
Mobilization
0-24 hours postoperatively
- +2 more secondary outcomes
Study Arms (2)
Ropivacaine
EXPERIMENTAL8 ml of ropivacaine 7,5 mg/ml will be injected around nervus cutaneous femoral lateralis. Ultrasound-guided.
Placebo
PLACEBO COMPARATOR8 ml of isotonic saline will be injected around nervus cutaneous femoral lateralis. Ultrasound-guided
Interventions
Eligibility Criteria
You may qualify if:
- Primary total hip replacement
You may not qualify if:
- general anaesthesia
- Allergy to local anesthetics of the amide type
- Revision surgery
- Bilateral surgery
- Chronic pain patient
- Women in the fertile age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Daniel Hägi-Pedersen, M.D., Ph.D.
Naestved Hospital, Department of Anaesthesiology
Study Design
- Study Type
- interventional
- Phase
- phase 4
- 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
- Consultant
Study Record Dates
First Submitted
November 10, 2014
First Posted
November 13, 2014
Study Start
March 1, 2014
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
November 13, 2014
Record last verified: 2014-11