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Regional anaesthesia of the cutaneus nerves of the hip - A randomized controlled trial of the transversalis fascia plane block

Regional anaesthesia of the cutaneus nerves of the hip - A randomized controlled trial of the transversalis fascia plane block

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2016-004377-41-DK
Enrollment
Unknown
Registered
2016-10-28
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

Sponsors

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

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 55 kg - Request to leave the trial - Infection in the area of injection

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the success of the transversals fascia plane (TFP) block in producing cutaneous anesthesia proximal to - and continous with - the area of anesthesia produced by the lateral femoral cutaneous nerve (LFCN) block;Secondary Objective: -Evaluating the cutaneous anesthesia after a selective subcostal nerve block -Evaluating the cutaneous anesthesia after the TFP block;Primary end point(s): Success rate of the TFP block with local anesthetic to produce a cutaneous area of anesthesia that is continous with the anesthetized cutaneous area after a LFCN block, compared to placebo.;Timepoint(s) of evaluation of this end point: 30 minutes after relevant nerve blocks

Secondary

MeasureTime frame
Secondary end point(s): - Time needed to do the subcostal nerve block - Succes rate of ultrasonographic (US) visualization of the subcostal nerve just caudate to the 12th costa - Succes rate of US visualization of the subcostal nerve at location where the lateral cutaneous nerve is branching off - Success rate of US visualization of the subcostal lateral cutaneous nerve in its course through the external oblique muscle -Succes rate of relevant cutaneous anesthesia after subcostal nerve block - Succes rate of relevant cutaneous anesthesia after subcostal nerve block produced by the primary injection - Extent of the cutaneous area anesthetized after subcostal 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 subcostal nerve block - Success rate of each of the incisions in being partly covered by the cutaneous anesthesia after subcostal nerve block -Rate of complete failure for each of the incisions to be covered by any cutaneous anesthesia after subcostal nerve block -Success rate of the LFCN block to produce a cutaneous area of anesthesia that is continous with the anesthetized cutaneous area after the subcostal nerve block on day one -Success rate of the LFCN block to produce a cutaneous area of anesthesia that is continous with the anesthetized cutaneous area after the subcostal nerve block on day one measured on a vertical line through the greater trochanter - Success rate of each of the incisions in being completely covered by the cutaneous anesthesia after subcostal nerve block and LFCN nerve block - Time needed to do the TFP block -Success rate of the TFP block with local anesthetic to produce a cutaneous area of anesthesia that is continous with the anesthetized cutaneous area after a LFCN block, compared to placebo, measured on a vertical line through the greater trochanter - Success rate of each of t

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