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General or Regional Anesthesia for Hip Surgery

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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:
Information provided by (Responsible Party):
Andreas Harsten, Region Skane

Tracking Information
First Submitted Date  ICMJE November 20, 2012
First Posted Date  ICMJE November 27, 2012
Results First Submitted Date  ICMJE April 7, 2016
Results First Posted Date  ICMJE March 18, 2019
Last Update Posted Date June 19, 2019
Study Start Date  ICMJE January 2013
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE General or Regional Anesthesia for Hip Surgery
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • 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  ICMJE
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 26, 2012)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 46 Years to 84 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01733472
Other Study ID Numbers  ICMJE Hip-CPH-2013
Hässleholm2013 ( Other Identifier: Region Skåne )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Andreas Harsten, Region Skane
Study Sponsor  ICMJE Region Skane
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andreas Harsten, M.D. Region Skane
PRS Account Region Skane
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP