Regional anaesthesia of the cutaneous nerves of the hip -A novel ultrasound guided nerve block of the superior cluneal nerves

Phase 1

Conditions: Postoperative pain after hip surgery
MedDRA version: 19.0Level: SOCClassification code 10022891Term: InvestigationsSystem Organ Class: 10022891 - Investigations
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2016-004541-82-DK

Lead Sponsor: Dep. Anaesthesia and Intensive Care, Aarhus University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

-Age = 18 years
- Written informed consent
- ASA i or II
-Mentally capable of cooperating during the trial.
-Understanding and speaking Danish or English
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Pre-existing neurological pathology involving the area of investigation
-Anatomical or mental aspects that would hinder nerve blocks
- Allergy to local anesthetics
- Current pregnancy
- Weight less than 60 kg
- BMI > 30
- Request to leave the trial
- Infection in the area of injection

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the success of a nerve block of the superior cluneal nerves (SupClun) in<br>producing cutaneous anaesthesia posterior to - and continous with - the area of anesthesia produced by the lateral femoral cutaneous nerve (LFCN) block and the Transversalis Fascia Plane (TFP) block ;Secondary Objective: -Evaluate the characteristics of a novel nerve block technique anaesthetising the superior cluneal nerves <br>-Evaluate the anaesthetized skin-area after nerve block of the superior cluneal nerves<br>- Evaluate the the superior cluneal nerve block, together with the LFCN block and the TFP block in relation to the most used incisions for hip surgery;Primary end point(s): Success rate of the SupClun nerve block with local anesthetic to produce a<br>cutaneous area of anesthesia that is continous with the anesthetized cutaneous area after a TFP nerve block, compared to placebo.;Timepoint(s) of evaluation of this end point: 45 minutes after nerve block

Secondary Outcome Measures