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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-004501-12-DK

Enrollment

Unknown

Registered

2013-12-10

Start date

2013-12-20

Completion date

Unknown

Last updated

2016-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain after total hip replacement surgery MedDRA version: 17.0 Level: LLT Classification code 10044088 Term: Total hip replacement System Organ Class: 100000004865 MedDRA version: 17.0 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 100000004863

Interventions

Trade Name: Naropin Pharmaceutical Form: Solution for injection INN or Proposed INN: Naropin Other descriptive name: ROPIVACAINE HYDROCHLORIDE Concentration unit: mg/l milligram(s)/litre Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

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

Measure

Time frame

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

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Countries

Denmark

Contacts

Public ContactOffice

Departement of Anesthesiology, Næstved Hospital

anaestesisekretariat@regionsjaelland.dk+4556514002

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 13, 2026