Does combined nerve block of the femoral nerve and the obturator nerve reduce pain more that nerve block of the femoral nerve alone, in patients with hip fracture.

Preoperative analgesic affect of combined obturator and femoral nerve block compared to femoral nerve block alone, in patients with hip fracture.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002304-89-DK

Enrollment

Registered

2015-06-29

Start date

2015-07-30

Completion date

Unknown

Last updated

2020-11-30

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

Conditions

Hip fracture MedDRA version: 18.1 Level: LLT Classification code 10017284 Term: Fractured femoral neck System Organ Class: 100000004863

Interventions

Trade Name: Marcain Product Name: Marcain Pharmaceutical Form: Solution for injection INN or Proposed INN: Bupivacaine Other descriptive name: BUPIVACAINE HYDROCHLORIDE Concentration unit: mg/ml milli

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Clinical suspicion of hip fracture Age = 55 years Mentally capable of comprehending and using verbal pain score and distinguish between pain from the fractured hip and pain from other location. Arrival in the emergency room at times when one of the doctors who do the nerve blocks for this investigation are on call Verbal pain score (0-10) > 3 at rest or > 5 with dynamic test Patients 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 8 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 82

Exclusion criteria

Exclusion criteria: Hip fracture not confirmed by x-ray Weight < 40 kg Patient has previously been included in this trial If the patient wishes to be excluded Visible infection in the area of the point of needle injection

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of the trail is to investigate if the combination af a femoral and a obturator nerve block provides better analgesia that a femoral nerve block alone, in patients with hip fracture;Secondary Objective: Course of analgesic effect Patient satisfaction Feasibility of nerve blocks Time used for nerve blocks Relation between type of fracture and analgesic effect;Primary end point(s): Succesrate of succesful analgesic effect 30 minutes after nerve blocks compared between the groups;Timepoint(s) of evaluation of this end point: 30 minutes	—

Measure

Time frame

Main Objective: The objective of the trail is to investigate if the combination af a femoral and a obturator nerve block provides better analgesia that a femoral nerve block alone, in patients with hip fracture;Secondary Objective: Course of analgesic effect Patient satisfaction Feasibility of nerve blocks Time used for nerve blocks Relation between type of fracture and analgesic effect;Primary end point(s): Succesrate of succesful analgesic effect 30 minutes after nerve blocks compared between the groups;Timepoint(s) of evaluation of this end point: 30 minutes

—

Secondary

Measure	Time frame
Secondary end point(s): Median NRS 30 minutes after nerve blocks. Course of pain reduction until 30 minutes. Time to succesful analgesic effect. Cutaneous termanalgesia in the area of RCA of the femoral nerve and the saphenous nerve compared to the analgesic effect. Focus af worst pain before nerve blocks and after 30 minutes. Discomfort related to the block procedure Patient satisfaction with analgesia 30 minutes after block. Frequency of possible ultrasonographic visualization of the femoral nerve and area of injection for the obturator nerve block. Time used for femoral nerve block. Time used for obturator nerve block. Total amount of opioid given from the time of nerve blok to operation compared between groups Amount of opioid per time-unit given from the time of nerve block to operation compared between groups. Total amount of opioid given from the time of nerve blok until 10 hours after, compared between groups. Amount of opioid per time-unit given from the time of nerve block until 10 hours after, compared between groups. ;Timepoint(s) of evaluation of this end point: 0 minutes 30 minutes 10 hours Approx 24 hours	—

Measure

Time frame

Secondary end point(s): Median NRS 30 minutes after nerve blocks. Course of pain reduction until 30 minutes. Time to succesful analgesic effect. Cutaneous termanalgesia in the area of RCA of the femoral nerve and the saphenous nerve compared to the analgesic effect. Focus af worst pain before nerve blocks and after 30 minutes. Discomfort related to the block procedure Patient satisfaction with analgesia 30 minutes after block. Frequency of possible ultrasonographic visualization of the femoral nerve and area of injection for the obturator nerve block. Time used for femoral nerve block. Time used for obturator nerve block. Total amount of opioid given from the time of nerve blok to operation compared between groups Amount of opioid per time-unit given from the time of nerve block to operation compared between groups. Total amount of opioid given from the time of nerve blok until 10 hours after, compared between groups. Amount of opioid per time-unit given from the time of nerve block until 10 hours after, compared between groups. ;Timepoint(s) of evaluation of this end point: 0 minutes 30 minutes 10 hours Approx 24 hours

—

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