Skip to main content
OpenTrials
Completed

NCT Number: NCT01733472

General or Regional Anesthesia for Hip Surgery

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis Agnosia Arthritis Joint Diseases Musculoskeletal Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Rheumatic Diseases Signs and Symptoms

Age range

46 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept Orthopedic Surgey, Hässleholm Hospital, PO Box 351,

Hässleholm, 28125, Sweden

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GA-arm, remifentanil

Drug

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

Other names: GA: TCI consisting of remifentanil an propofol

RA-arm

Drug

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

Other names: Regional anesthesia

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study title

General Versus Intrathecal Anaesthesia for Patients Undergoing Elective Total Hip Arthroplasty

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 27, 2012
Registry last updated
Jun 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.