General or Regional Anesthesia for Hip Surgery

• ClinicalTrials.gov Identifier: NCT01733472
• Recruitment Status: Completed
• First Posted: November 27, 2012
• Results First Posted: March 18, 2019
• Last Update Posted: June 19, 2019
• Sponsor: Region Skane
• Information provided by (Responsible Party): Andreas Harsten, Region Skane

Tracking Information

• First Submitted Date: November 20, 2012
• First Posted Date: November 27, 2012
• Results First Submitted Date: April 7, 2016
• Results First Posted Date: March 18, 2019
• Last Update Posted Date: June 19, 2019
• Study Start Date: January 2013
• Actual Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 5, 2018)

Length of Hospital Stay [ Time Frame: Up to 4 days after surgery ]

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

Original Primary Outcome Measures (submitted: November 26, 2012)

Length of Hospital Stay [ Time Frame: 4 days after surgery ]

Time from the end of surgery until the patients meets the discharge criteria will be evaluated

Current Secondary Outcome Measures (submitted: June 10, 2019)

Post Operative Pain [ Time Frame: from end of surgey until 48 hrs later ]

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)

Original Secondary Outcome Measures (submitted: November 26, 2012)

Post Operative Pain [ Time Frame: from end of surgey until 48 hrs later ]

Pain will be monitored using a Visual Analogue Scale. Pain will be monitored with the patient in four different positions

Current Other Pre-specified Outcome Measures (submitted: December 5, 2018)

Time Hrs Until the Patient Meets the Discharge Criteria From PACU [ Time Frame: 12 hrs ]

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

Original Other Pre-specified Outcome Measures (submitted: November 26, 2012)

Time until the patient meets the discharge criteria from PACU [ Time Frame: 12 hrs ]

Time 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

Descriptive Information

• Brief Title: General or Regional Anesthesia for Hip Surgery
• Official Title: General Versus Intrathecal Anaesthesia for Patients Undergoing Elective Total Hip Arthroplasty
• 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

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Osteoarthritis

Intervention

• Drug: GA-arm, remifentanil
  Remifentanil and propofol will be delivered intravenously via TCI pumps according to the "Marsh" and "Minto" algorithm
  Other Name: GA: TCI consisting of remifentanil an propofol
• Drug: RA-arm
  Intrathecal (i.e. spinal) anesthesia with isobaric bupivacaine 15 mg administered intrathecally at L4-L5.
  Other Name: Regional anesthesia

Study Arms

• Placebo Comparator: RA-arm
  RA-arm: the patients in this arm will receive intrathecal anaesthesia consisting of bupivacaine 15 mg
  Intervention: Drug: RA-arm
• Experimental: GA-arm, remifentanil
  GA-arm: patients in this arm will receive general anaesthesia consisting of Target Controlled Infusion (TCI) of remifentanil and propofol
  Intervention: Drug: GA-arm, remifentanil

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. Review.
• 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.
• Minto CF, Schnider TW, Shafer SL. Pharmacokinetics and pharmacodynamics of remifentanil. II. Model application. Anesthesiology. 1997 Jan;86(1):24-33.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 26, 2012): 120
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: June 2014
• Actual Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 46 Years to 84 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT01733472
• Other Study ID Numbers: Hip-CPH-2013; Hässleholm2013 ( Other Identifier: Region Skåne )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Andreas Harsten, Region Skane
• Study Sponsor: Region Skane
• Collaborators: Not Provided

Investigators

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

• PRS Account: Region Skane
• Verification Date: June 2019