General or Regional Anesthesia for Hip Surgery

NCT01733472 | Completed Results DMC

• 2 other identifiers: Hip-CPH-2013Hässleholm2013
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteoarthritis

Keywords

anaesthetic techniques; subarachnoid; analgesia

Outcome Measures

Primary Outcomes (1)

• Length of Hospital Stay

  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

  Up to 4 days after surgery

Secondary Outcomes (1)

• Post Operative Pain

  from end of surgey until 48 hrs later

Other Outcomes (1)

• Time Hrs Until the Patient Meets the Discharge Criteria From PACU

  12 hrs

Study Arms (2)

RA-arm

PLACEBO COMPARATOR

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

Drug: RA-arm

GA-arm, remifentanil

EXPERIMENTAL

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

Drug: GA-arm, remifentanil

Interventions

GA-arm, remifentanil DRUG

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

Also known as: GA: TCI consisting of remifentanil an propofol

GA-arm, remifentanil

RA-arm DRUG

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

Also known as: Regional anesthesia

RA-arm

Eligibility Criteria

• Age: 46 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Dept Orthopedic Surgey, Hässleholm Hospital, PO Box 351,

Hässleholm, 28125, Sweden

Location

Related Publications (4)

• 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.

  PMID: 18211990 BACKGROUND

• 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. No abstract available.

  PMID: 2361330 BACKGROUND

• Minto CF, Schnider TW, Shafer SL. Pharmacokinetics and pharmacodynamics of remifentanil. II. Model application. Anesthesiology. 1997 Jan;86(1):24-33. doi: 10.1097/00000542-199701000-00005.

  PMID: 9009936 BACKGROUND

• 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. No abstract available.

  PMID: 25736216 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis; Agnosia

Interventions

Remifentanil; Anesthesia, Conduction

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anesthesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Andreas Harsten
• Organization: Region Skane

andreas.harsten@skane.se

46708870567

Study Officials

• Andreas Harsten, M.D.

  Region Skane

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: November 20, 2012
• First Posted: November 27, 2012
• Study Start: January 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 19, 2019
• Results First Posted: March 18, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)