General or Regional Anesthesia for Hip Surgery

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ClinicalTrials.gov Identifier: NCT01733472

Recruitment Status : Completed

First Posted : November 27, 2012

Results First Posted : March 18, 2019

Last Update Posted : June 19, 2019

Sponsor:

Information provided by (Responsible Party):

Andreas Harsten, Region Skane

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Osteoarthritis	Drug: GA-arm, remifentanil Drug: RA-arm	Not Applicable

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	120 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	General Versus Intrathecal Anaesthesia for Patients Undergoing Elective Total Hip Arthroplasty
Study Start Date :	January 2013
Actual Primary Completion Date :	February 2014
Actual Study Completion Date :	June 2014

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Osteoarthritis

Drug Information available for: Propofol Remifentanil hydrochloride

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: RA-arm RA-arm: the patients in this arm will receive intrathecal anaesthesia consisting of bupivacaine 15 mg	Drug: RA-arm Intrathecal (i.e. spinal) anesthesia with isobaric bupivacaine 15 mg administered intrathecally at L4-L5. Other Name: Regional anesthesia
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 propofol

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 Outcome Measures:

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

Eligibility Criteria

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Ages Eligible for Study:	46 Years to 84 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01733472

Locations

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Sweden
Dept Orthopedic Surgey, Hässleholm Hospital, PO Box 351,
Hässleholm, Sweden, 28125

Sponsors and Collaborators

Region Skane

Investigators

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Principal Investigator:	Andreas Harsten, M.D.	Region Skane

More Information

Publications:

Fowler SJ, Symons J, Sabato S, Myles PS. Epidural analgesia compared with peripheral nerve blockade after major knee surgery: a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2008 Feb;100(2):154-64. doi: 10.1093/bja/aem373. Review.

Marsh BJ, Morton NS, White M, Kenny GN. A computer controlled infusion of propofol for induction and maintenance of anaesthesia in children. Can J Anaesth. 1990 May;37(4 Pt 2):S97.

Minto CF, Schnider TW, Shafer SL. Pharmacokinetics and pharmacodynamics of remifentanil. II. Model application. Anesthesiology. 1997 Jan;86(1):24-33.

Harsten A, Kehlet H, Ljung P, Toksvig-Larsen S. Total intravenous general anaesthesia vs. spinal anaesthesia for total hip arthroplasty. Acta Anaesthesiol Scand. 2015 Apr;59(4):542-3. doi: 10.1111/aas.12495. Epub 2015 Mar 3.

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Responsible Party:	Andreas Harsten, M.D., Region Skane
ClinicalTrials.gov Identifier:	NCT01733472
Other Study ID Numbers:	Hip-CPH-2013 Hässleholm2013 ( Other Identifier: Region Skåne )
First Posted:	November 27, 2012 Key Record Dates
Results First Posted:	March 18, 2019
Last Update Posted:	June 19, 2019
Last Verified:	June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Andreas Harsten, Region Skane:


anaesthetic techniques subarachnoid analgesia

Additional relevant MeSH terms:

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Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Remifentanil Propofol Anesthetics Central Nervous System Depressants	Physiological Effects of Drugs Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General Analgesics, Opioid Narcotics Analgesics Sensory System Agents Peripheral Nervous System Agents

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