General or Regional Anesthesia for Hip Surgery

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-06-30

Brief Summary

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

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Detailed Description

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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

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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RA-arm

RA-arm: the patients in this arm will receive intrathecal anaesthesia consisting of bupivacaine 15 mg

Group Type PLACEBO_COMPARATOR

RA-arm

Intervention Type DRUG

Intrathecal (i.e. spinal) anesthesia with isobaric bupivacaine 15 mg administered intrathecally at L4-L5.

GA-arm, remifentanil

GA-arm: patients in this arm will receive general anaesthesia consisting of Target Controlled Infusion (TCI) of remifentanil and propofol

Group Type EXPERIMENTAL

GA-arm, remifentanil

Intervention Type DRUG

Remifentanil and propofol will be delivered intravenously via TCI pumps according to the "Marsh" and "Minto" algorithm

Interventions

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GA-arm, remifentanil

Remifentanil and propofol will be delivered intravenously via TCI pumps according to the "Marsh" and "Minto" algorithm

Intervention Type DRUG

RA-arm

Intrathecal (i.e. spinal) anesthesia with isobaric bupivacaine 15 mg administered intrathecally at L4-L5.

Intervention Type DRUG

Other Intervention Names

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GA: TCI consisting of remifentanil an propofol Regional anesthesia

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

46 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No