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General or Regional Anesthesia for Hip Surgery

This study has been completed.
Information provided by (Responsible Party):
Andreas Harsten, Region Skane Identifier:
First received: November 20, 2012
Last updated: November 5, 2014
Last verified: November 2014
The purpose of this study is to determine whether general anaesthesia or regional anaesthesia is best for patients undergoing Total Hip Arthroplasty.

Condition Intervention
Drug: GA-arm, remifentanil
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: General Versus Intrathecal Anaesthesia for Patients Undergoing Elective Total Hip Arthroplasty

Resource links provided by NLM:

Further study details as provided by Region Skane:

Primary Outcome Measures:
  • Length of hospital stay [ Time Frame: 4 days after surgery ] [ Designated as safety issue: No ]
    Time from the end of surgery until the patients meets the discharge criteria will be evaluated

Secondary Outcome Measures:
  • Post operative pain [ Time Frame: from end of surgey until 48 hrs later ] [ Designated as safety issue: No ]
    Pain will be monitored using a Visual Analogue Scale. Pain will be monitored with the patient in four different positions

Other Outcome Measures:
  • Time until the patient meets the discharge criteria from PACU [ Time Frame: 12 hrs ] [ Designated as safety issue: No ]
    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

Enrollment: 120
Study Start Date: January 2013
Study Completion Date: June 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: RA-arm
RA-arm: the patients in this arm will receive intrathecal anaesthesia consisting of bupivacaine 15 mg
Drug: placebo
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 Name: GA: TCI consisting of remifentanil an dpropofol

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:


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


Ages Eligible for Study:   46 Years to 84 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01733472

Dept Orthopedic Surgey, Hässleholm Hospital, PO Box 351,
Hässleholm, Sweden, 28125
Sponsors and Collaborators
Region Skane
Principal Investigator: Andreas Harsten, M.D. Region Skane
  More Information

Responsible Party: Andreas Harsten, M.D., Region Skane Identifier: NCT01733472     History of Changes
Other Study ID Numbers: Hip-CPH-2013  Hässleholm2013 
Study First Received: November 20, 2012
Last Updated: November 5, 2014
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Region Skane:
anaesthetic techniques

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General processed this record on October 28, 2016