Clinical trial NCT01593319: Is Regional Anesthesia of the Hip Preferable Over Traditional Analgesia in the Acute Stage of the Management of Patients With a Fracture of the Hip
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hip Fractures
Lead sponsor: Landstinget i Värmland
Sponsor class: OTHER
First posted: 2012-05-08
Enrollment: 37
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The main hypothesis of the study is that anaesthesia of the hip using infiltration with a local anesthetic solution is preferable over traditional analgesia with oral opioid medications in the acute stage of the management of patients with a fracture of the hip.

To study the hypothesis the investigators designed a prospective randomised study where patients are assigned in two groups, the first receiving local hip anesthesia and the other placebo treatment. Both groups are eligible to use of standard oral pain treatment.

Effect of analgesia as well as medical complications will be recorded.


Eligibility criteria: Inclusion Criteria:

* fracture of the hip

Exclusion Criteria:

* multiple fractures,
* delay (more than 12 hours) from the time of injury until admission to the hospital,
* local infections, hypersensitivity to local analgetics,
* cognitive impairment

Primary outcomes:
measure: Pain
timeFrame: 3 hours
Secondary outcomes:
measure: medical complications (Number of participants that develop pressure ulcers, number of participants that develop pneumonia)
timeFrame: under hospitalization (expected average of 10 days)
Other outcomes:
Locations:
city: Karlstad
country: Sweden
facility: Ortopedkliniken, Centralsjukhuset i Karlstad
state: Värmland
Study officials:
affiliation: Centrum för klinisk forskning. Centralsjukhuset, 651 85 Karlstad, Sweden
name: Anders Hallberg, Forskningsschef
role: STUDY_CHAIR
References:
citation: Brisbane Orthopaedic & Sports Medicine Centre Writing Committee; McMeniman TJ, McMeniman PJ, Myers PT, Hayes DA, Cavdarski A, Wong MS, Wilson AJ, Jones MA, Watts MC. Femoral nerve block vs fascia iliaca block for total knee arthroplasty postoperative pain control: a prospective, randomized controlled trial. J Arthroplasty. 2010 Dec;25(8):1246-9. doi: 10.1016/j.arth.2009.11.018. Epub 2010 Feb 23.
citation: Candal-Couto JJ, McVie JL, Haslam N, Innes AR, Rushmer J. Pre-operative analgesia for patients with femoral neck fractures using a modified fascia iliaca block technique. Injury. 2005 Apr;36(4):505-10. doi: 10.1016/j.injury.2004.10.015.
citation: Fletcher AK, Rigby AS, Heyes FL. Three-in-one femoral nerve block as analgesia for fractured neck of femur in the emergency department: a randomized, controlled trial. Ann Emerg Med. 2003 Feb;41(2):227-33. doi: 10.1067/mem.2003.51.
citation: Foss NB, Kristensen BB, Bundgaard M, Bak M, Heiring C, Virkelyst C, Hougaard S, Kehlet H. Fascia iliaca compartment blockade for acute pain control in hip fracture patients: a randomized, placebo-controlled trial. Anesthesiology. 2007 Apr;106(4):773-8. doi: 10.1097/01.anes.0000264764.56544.d2.
citation: Hogh A, Dremstrup L, Jensen SS, Lindholt J. Fascia iliaca compartment block performed by junior registrars as a supplement to pre-operative analgesia for patients with hip fracture. Strategies Trauma Limb Reconstr. 2008 Sep;3(2):65-70. doi: 10.1007/s11751-008-0037-9. Epub 2008 Sep 2.
citation: Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.