General or Regional Anesthesia for Hip Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Region Skane
Sponsor:
Information provided by (Responsible Party):
Andreas Harsten, Region Skane
ClinicalTrials.gov Identifier:
NCT01733472
First received: November 20, 2012
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention
Osteoarthritis
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


Estimated Enrollment: 120
Study Start Date: January 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (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:

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

Ages Eligible for Study:   46 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT01733472

Contacts
Contact: Andreas Harsten, M.D. +46 768 870567 andreas.harsten@skane.se

Locations
Sweden
Dept Orthopedic Surgey, Hässleholm Hospital, PO Box 351, Recruiting
Hässleholm, Sweden, 28125
Contact: Andreas Harsten, M.D.    +46 768 870567    andreas.harsten@skane.se   
Principal Investigator: Andreas Harsten, M.D.         
Sponsors and Collaborators
Region Skane
Investigators
Principal Investigator: Andreas Harsten, M.D. Region Skane
  More Information

Publications:
Responsible Party: Andreas Harsten, M.D., Region Skane
ClinicalTrials.gov Identifier: NCT01733472     History of Changes
Other Study ID Numbers: Hip-CPH-2013, Hässleholm2013
Study First Received: November 20, 2012
Last Updated: November 18, 2013
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Region Skane:
anaesthetic techniques
subarachnoid
analgesia

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anesthetics
Remifentanil
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on September 16, 2014