Effect of a lateral nerve of the thigh block on postoperative pain after total hip replacement surgery: a clinical radomised trial.

Phase 1

Conditions: Pain after total hip replacement surgery
MedDRA version: 17.0Level: LLTClassification code 10044088Term: Total hip replacementSystem Organ Class: 100000004865
MedDRA version: 17.0Level: LLTClassification code 10054711Term: Postoperative painSystem Organ Class: 100000004863
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

Registration Number: EUCTR2013-004501-12-DK

Lead Sponsor: Departement of Anesthesiology, Næstved Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

All patients to primary total hip replacement.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

Patients undergoing general anesthesia
Allergy to local anesthetics of the amide type.
Revision surgery.
Bilateral surgery.
Chronic pain patient
Women in the fertile age

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Investigation of the influence of a lateral cutaneus nerve of the thigh block on postoperative pain after total hip replacement surgery with visual analog scale. Total oxynorm dose 1. day after surgery.;Secondary Objective: Total oxynorm dose under the complete admission. Time from operation to the first dose of oxynorm. Reduced motoric function under early mobilisation (CAS-score). Time for the first mobilisation. Total admissiontime.;Primary end point(s): 1. Visual analog pain scale of the patients under movement (elevetion of the operated leg 30 degree above bed or similar.;Timepoint(s) of evaluation of this end point: 1. VAS score at time 4 hours after admission of the block.<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Total oxynorm administration under the 1. day of admission<br>2. VAS score<br>3. Total oxynorm administratin under the whole admission<br>4 Time from the admission of the block to the first administration of oxynorm<br>5. Validation of the motor block under the early mobilisation<br>6. Time for the first mobilisation<br>6. Total admissiontime to the ward;Timepoint(s) of evaluation of this end point: 1. After discharge of the patient<br>2. Time: 0, 1, 2, 4, 8, 12 and 24 hours after admission of the block<br>3. After discharge of the patient<br>4. After discharge of the patient<br>5. After the first mobilisation of the patient<br>6. After the first mobilisation of the patient<br>7. After discharge of the patient