General or Regional Anesthesia for Hip Surgery

General Versus Intrathecal Anaesthesia for Patients Undergoing Elective Total Hip Arthroplasty

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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Drug: RA-arm; Drug: GA-arm, remifentanil

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

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Hässleholm, Sweden, 28125
    • Dept Orthopedic Surgey, Hässleholm Hospital, PO Box 351,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years to 84 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: RA-arm; RA-arm: the patients in this arm will receive intrathecal anaesthesia consisting of bupivacaine 15 mg	Drug: RA-arm; Intrathecal (i.e. spinal) anesthesia with isobaric bupivacaine 15 mg administered intrathecally at L4-L5.; Other Names: Regional anesthesia
Experimental: GA-arm, remifentanil; GA-arm: patients in this arm will receive general anaesthesia consisting of Target Controlled Infusion (TCI) of remifentanil and propofol	Drug: GA-arm, remifentanil; Remifentanil and propofol will be delivered intravenously via TCI pumps according to the "Marsh" and "Minto" algorithm; Other Names: GA: TCI consisting of remifentanil an propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Hospital Stay	Time from the end of surgery until the patients meets the discharge criteria will be evaluated. Discharge criteria: able to get in and out of bed, Able to get dressed. Able to sit down in a chair and get up again. Able to walk 50 meters wit/without crutches. Able to flex knee 70 degrees. Able to walk stairs. Pain manageable with oral analgesics. Acceptance to be discharged	Up to 4 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post Operative Pain	Pain will be monitored using a Visual Analogue Scale. Pain will be monitored with the patient in four different positions. VAS 100 mm used for assessment of pain (0 = no pain, 100 = worst imaginable pain). At each time and position the median VAS-pain score was reported (generally the distribution of pain scores are not normally distributed and hence median value was used)	from end of surgey until 48 hrs later

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Hrs Until the Patient Meets the Discharge Criteria From PACU	Hours until the patient meets the discharge criteria from PACU will be monitored every 15 min from teh time the patient arrives to PACU until he/she meets the discharge criteria	12 hrs

Collaborators and Investigators

• Sponsor: Region Skane
• Investigators: Principal Investigator: Andreas Harsten, M.D., Region Skane

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: November 20, 2012
• First Submitted That Met QC Criteria: November 26, 2012
• First Posted (Estimate): November 27, 2012

Study Record Updates

• Last Update Posted (Actual): June 19, 2019
• Last Update Submitted That Met QC Criteria: June 10, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: analgesia; anaesthetic techniques; subarachnoid
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Remifentanil; Propofol
• Other Study ID Numbers: Hip-CPH-2013; Hässleholm2013 (Other Identifier: Region Skåne)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO