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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02289937
• Other study ID #: 001-2013
• Secondary ID: 2013-004501-12
• Status: Completed
• Phase: Phase 4
• First received: November 10, 2014
• Last updated: November 12, 2014
• Start date: March 2014
• Est. completion date: October 2014

Study information

• Verified date: November 2014
• Source: Naestved Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia, Conduction
• Arthroplasty, Replacement, Hip
• Pain, Postoperative

Intervention

Drug:
• Ropivacaine

• Placebo

Device:
• An ultrasound-guided Nervus cutaneous femoral lateralis blockade will be given postoperatively

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daniel Hägi-Pedersen

Outcome

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