Effect of a Lateral Nerve of the Thigh Block on Postoperative Pain After Total Hip Replacement Surgery

Effect of a Lateral Nerve of the Thigh Block on Postoperative Pain After Total Hip Replacement Surgery: a Clinical Randomized Trial

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Arthroplasty, Replacement, Hip; Anesthesia, Conduction
• Intervention / Treatment: Drug: Placebo; Drug: Ropivacaine; Device: An ultrasound-guided Nervus cutaneous femoral lateralis blockade will be given postoperatively

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ropivacaine; 8 ml of ropivacaine 7,5 mg/ml will be injected around nervus cutaneous femoral lateralis. Ultrasound-guided.	Drug: Ropivacaine; Other Names: Naropin; Device: An ultrasound-guided Nervus cutaneous femoral lateralis blockade will be given postoperatively
Placebo Comparator: Placebo; 8 ml of isotonic saline will be injected around nervus cutaneous femoral lateralis. Ultrasound-guided	Drug: Placebo; Other Names: Saline, NaCl; Device: An ultrasound-guided Nervus cutaneous femoral lateralis blockade will be given postoperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0-24 hours postoperatively
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.	0-24 hours postoperatively
Oxynorm consumption	Oxynorm consumption 24 hours postoperative	0-24 hours postoperative
time to first oxynorm requirement		0-24 hours postoperatively
Mobilization	time to first mobilization	0-24 hours postoperatively
Mobilization	Ability to mobilize judged by the cumulated ambulation (CAS) score: 0-6; 0 no mobilization, 6: fully mobilized	0-24 hours postoperatively
Length of stay		0-7 days postoperative

Collaborators and Investigators

• Sponsor: Daniel Hägi-Pedersen
• Investigators: Study Chair: Daniel Hägi-Pedersen, M.D., Ph.D., Naestved Hospital, Department of Anaesthesiology

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: November 10, 2014
• First Submitted That Met QC Criteria: November 12, 2014
• First Posted (Estimate): November 13, 2014

Study Record Updates

• Last Update Posted (Estimate): November 13, 2014
• Last Update Submitted That Met QC Criteria: November 12, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: total hip replacement; Postoperative pain; regional anaesthesia; nervus cutaneous femoral lateralis
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 001-2013; 2013-004501-12 (EudraCT Number)