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Effect and safety of a new nerve block - the iliopsoas plane block - for treatment of pain after major hip surgery in healthy volunteers

Effect and safety of the iliopsoas plane block in healthy volunteers - HIP/FUSION#4

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2018-000089-12-DK
Enrollment
22
Registered
2018-03-12
Start date
2018-04-24
Completion date
Unknown
Last updated
2018-07-23

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

Conditions

No specific medical condition is investigated. The objective of the trial is to investigate a method for postoperative analgesia after elective hip surgery. MedDRA version: 20.0 Level: LLT Classification code 10068084 Term: Anesthesia procedure System Organ Class: 100000004865

Interventions

Trade Name: Lidokain-adrenalin SAD Pharmaceutical Form: Injection INN or Proposed INN: LIDOCAINE HYDROCHLORIDE Other descriptive name: Lidocaine hydrochloride Concentration unit: mg/ml milligram(s)/mi

Sponsors

Institut for Klinisk Medicin, Aarhus Universitet
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Age = 18 years - American Society of Anesthesiologists physical status classification score (ASA) I-II - Informed consent 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 22 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Lacking the ability to corporate - Lacking the ability to speak danish - Known neuropathy of the lower extremities - Chronic opioid demanding pain - Consumption of more than 14 resp. 21 units of alcohol/week for women resp. men. - Overweight (Body mass index (BMI) > 25 kg/m2) - Claustrofobia - Pregnancy - Allergy towards the used medicines - Daily consumption of medicine apart from oral contraceptives.

Design outcomes

Primary

MeasureTime frame
Main Objective: To investigate, whether the iliopsoas plane block affects the muscle strength of the quadriceps femoris muscle.;Secondary Objective: To estimate: - the effect of the iliopsoas plane block on the strength of the adductor muscles of the thigh. - the effect of the iliopsoas plane block on sensitivity in the dermatome of the lateral cutaneous femoral nerve. - the effect of the iliopsoas plane block on sensitivity in the dermatome of the femoral nerve. - if the injection from the iliopsoas plane block spreads in the whole iliopsoas plane. - if the injection from the iliopsoas plane block spreads to the space between the pectineus and the external obturator muscles. - if the injection from the iliopsoas plane block spreads superficial to the iliopsoas muscle. - if the injection from the iliopsoas plane block spreads intraarticularly in the hip joint. - if the injection from the iliopsoas plane block spreads to the posterior part of the hip joint capsule - if / how often the injection from the iliopsoas plane block is inside the iliopectineal bursa medial to the target area.;Primary end point(s): Change of maximal force of knee extension from baseline to after nerve blockade.;Timepoint(s) of evaluation of this end point: 1 hour after nerve blockade

Secondary

MeasureTime frame
Secondary end point(s): 1: Change of maximal force of hip adduction from baseline to after nerve blockade. 2: Change of maximal force of knee extension from baseline to after nerve blockade in the leg, where local anaesthetics are injected compared to the control leg. 3: Change of maximal force of hip adduction from baseline to after nerve blockade in the leg, where local anaesthetics are injected compared to the control leg. 4: Change of sensibility in the dermatome of the lateral femoral cutaneous nerve. 5: Change of sensibility in the dermatome of the femoral nerve. 6: Spread of contrast in the iliopsoas plane 7: Spread of contrast to the space between the pectinous and the external obturator muscles. 8: Spread of contrast to the superficial side of the iliopsoas muscle. 9: Intraarticular spread of contrast to the hip joint 10: Spread og contrast to the posterior side of the hip joint capsule. 11: Contrast in the iliopectineal bursa;Timepoint(s) of evaluation of this end point: 1-5: 1 hour after nerve blockade. 6-10: Evaluated by MRI-scan 5-60 minutes after nerve blockade.

Countries

Denmark

Contacts

Public ContactNiels Dalsgaard Nielsen

Center for Planlagt Kirurgi, Regionshospitalet Silkeborg

nielsdn@dadlnet.dk+4522838334

Outcome results

None listed

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