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General or Regional Anesthesia for Hip Surgery

R

Region Skane

Status

Completed

Conditions

Osteoarthritis

Treatments

Drug: GA-arm, remifentanil
Drug: RA-arm

Study type

Interventional

Funder types

Other

Identifiers

NCT01733472
Hässleholm2013 (Other Identifier)
Hip-CPH-2013

Details and patient eligibility

About

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

Full 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

Enrollment

120 patients

Sex

All

Ages

46 to 84 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

120 participants in 2 patient groups, including a placebo group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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