Clinical trial NCT01733472: General or Regional Anesthesia for Hip Surgery
Official title: General Versus Intrathecal Anaesthesia for Patients Undergoing Elective Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: anaesthetic techniques
subarachnoid
analgesia
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2012-11-27
Enrollment: 120
Sex: ALL
Minimum age (years): 46
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether general anaesthesia or regional anaesthesia is best for patients undergoing Total Hip Arthroplasty.

Detailed description: A randomized controlled trial (RCT) with a follow up time of 48 hrs. Patients scheduled for primary Total Hip Arthroplasty. A total of 120 patients randomly assigned to one of the two alternatives (general anaesthesia (GA) or regional anaesthesia (RA)).

General anaesthesia compared to intrathecal anaesthesia will give shorter length of hospital stay (LOS) for patients undergoing total hip arthroplasty (THA).

Primary endpoint:

LOS.

Secondary endpoints:

Postoperative pain? Postoperative orthostatic function (dizziness) Time until the patient meets the discharge criteria from PACU How many patients will need at least one urinary bladder catheterisation

Eligibility criteria: Inclusion Criteria: patients with osteoarthritis scheduled for surgery

* patients that will require THA
* patients over 45 yrs and under 85 yrs.
* patients that understand the given information and are willing to participate in this study
* patients who have signed the informed consent document.
* patients belonging to ASA class I-III.

Exclusion Criteria:

* prior surgery to the same hip
* patients with a history of stroke, neurological or psychiatric disease that potentially could affect the perception of pain
* obesity (BMI \> 35)
* active or suspected infection
* patients taking opioids or steroids
* patients suffering from rheumatoid arthritis or an immunological depression
* patients who are allergic to any of the drugs being used in this study

Primary outcomes:
measure: Length of Hospital Stay
timeFrame: Up to 4 days after surgery
Secondary outcomes:
measure: Post Operative Pain
timeFrame: from end of surgey until 48 hrs later
Other outcomes:
measure: Time Hrs Until the Patient Meets the Discharge Criteria From PACU
timeFrame: 12 hrs
Locations:
city: Hässleholm
country: Sweden
facility: Dept Orthopedic Surgey, Hässleholm Hospital, PO Box 351,
Study officials:
affiliation: Region Skane
name: Andreas Harsten, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fowler SJ, Symons J, Sabato S, Myles PS. Epidural analgesia compared with peripheral nerve blockade after major knee surgery: a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2008 Feb;100(2):154-64. doi: 10.1093/bja/aem373.
citation: Marsh BJ, Morton NS, White M, Kenny GN. A computer controlled infusion of propofol for induction and maintenance of anaesthesia in children. Can J Anaesth. 1990 May;37(4 Pt 2):S97. No abstract available.
citation: Minto CF, Schnider TW, Shafer SL. Pharmacokinetics and pharmacodynamics of remifentanil. II. Model application. Anesthesiology. 1997 Jan;86(1):24-33. doi: 10.1097/00000542-199701000-00005.
citation: Harsten A, Kehlet H, Ljung P, Toksvig-Larsen S. Total intravenous general anaesthesia vs. spinal anaesthesia for total hip arthroplasty. Acta Anaesthesiol Scand. 2015 Apr;59(4):542-3. doi: 10.1111/aas.12495. Epub 2015 Mar 3. No abstract available.