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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004541-82-DK

Enrollment

Unknown

Registered

2016-11-16

Start date

2016-12-19

Completion date

Unknown

Last updated

2017-04-10

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

Conditions

Postoperative pain after hip surgery MedDRA version: 19.0 Level: SOC Classification code 10022891 Term: Investigations System Organ Class: 10022891 - Investigations

Interventions

Trade Name: Ropivacain Product Name: Ropivacain Pharmaceutical Form: Solution for injection INN or Proposed INN: ROPIVACAINE CAS Number: 84057-95-4 Concentration unit: mg/ml milligram(s)/millilitre Co

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the success of a nerve block of the superior cluneal nerves (SupClun) in 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 -Evaluate the anaesthetized skin-area after nerve block of the superior cluneal nerves - 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 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	—

Measure

Time frame

Main Objective: To evaluate the success of a nerve block of the superior cluneal nerves (SupClun) in 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 -Evaluate the anaesthetized skin-area after nerve block of the superior cluneal nerves - 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 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

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Secondary

Measure	Time frame
Secondary end point(s): -Time to complete the SupClun nerve block -Success rate of each of the incisions (cannulated screws, DHS, IM nail, anterior-, anterolateral- lateral- and posterior approach) in being completely covered by the cutaneous anesthesia after TFP nerve block with local anaesthetic - Success rate of each of the incisions in being partly covered by the cutaneous anesthesia after TFP nerve block with local anesthetic -Rate of complete failure for each of the incisions to be covered by any cutaneous anesthesia after TFP nerve block with local anesthetic -Success rate of each of the incisions in being completely covered by the cutaneous anesthesia after LFCN nerve block and TFP block with local anesthetic - Success rate of each of the incisions in being partly covered by the cutaneous anesthesia after LFCN nerve block and TFP block with local anesthetic -Rate of complete failure for each of the incisions to be covered by any cutaneous anesthesia after LFCN nerve block and TFP block with local anesthetic -Success rate of the LFCN block to produce a cutaneous area of anesthesia that is continous with the anesthetized cutaneous area after the TFP nerve block - Success rate of the SupClun nerve block with local anesthetic to produce a relevant cutaneous area of anaesthesia, compared to placebo. - Rate of good, reduced or bad ultrasonographic visualization when doing the SubClun nerve block - Success rate of the SupClun nerve block with local anesthetic to produce a cutaneous area of anesthesia that is continous with the anesthetized cutaneous area after a LFCN nerve block, compared to placebo. - Success rate of the SupClun nerve block with local anesthetic to produce a cutaneous area of anesthesia that is continous with the anesthetized cutaneous area after both the TFP- and the LFCN nerve block, compared to placebo. - Extent of the area anaesthetised by the SupClun nerve block - Succes of the anaesthetised area of the SupClub nerve block overlapping the G	—

Measure

Time frame

Secondary end point(s): -Time to complete the SupClun nerve block -Success rate of each of the incisions (cannulated screws, DHS, IM nail, anterior-, anterolateral- lateral- and posterior approach) in being completely covered by the cutaneous anesthesia after TFP nerve block with local anaesthetic - Success rate of each of the incisions in being partly covered by the cutaneous anesthesia after TFP nerve block with local anesthetic -Rate of complete failure for each of the incisions to be covered by any cutaneous anesthesia after TFP nerve block with local anesthetic -Success rate of each of the incisions in being completely covered by the cutaneous anesthesia after LFCN nerve block and TFP block with local anesthetic - Success rate of each of the incisions in being partly covered by the cutaneous anesthesia after LFCN nerve block and TFP block with local anesthetic -Rate of complete failure for each of the incisions to be covered by any cutaneous anesthesia after LFCN nerve block and TFP block with local anesthetic -Success rate of the LFCN block to produce a cutaneous area of anesthesia that is continous with the anesthetized cutaneous area after the TFP nerve block - Success rate of the SupClun nerve block with local anesthetic to produce a relevant cutaneous area of anaesthesia, compared to placebo. - Rate of good, reduced or bad ultrasonographic visualization when doing the SubClun nerve block - Success rate of the SupClun nerve block with local anesthetic to produce a cutaneous area of anesthesia that is continous with the anesthetized cutaneous area after a LFCN nerve block, compared to placebo. - Success rate of the SupClun nerve block with local anesthetic to produce a cutaneous area of anesthesia that is continous with the anesthetized cutaneous area after both the TFP- and the LFCN nerve block, compared to placebo. - Extent of the area anaesthetised by the SupClun nerve block - Succes of the anaesthetised area of the SupClub nerve block overlapping the G

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Countries

Denmark

Contacts

Public ContactDep. Anaesthesia and Intensive Care

Aarhus University Hospital

thomas.dahl.nielsen@clin.au.dk+4528782877

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026