General or Regional Anesthesia for Hip Surgery

Osteoarthritis Clinical Trial

Official title:

General Versus Intrathecal Anaesthesia for Patients Undergoing Elective Total Hip Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01733472
• Other study ID #: Hip-CPH-2013
• Secondary ID: Hässleholm2013
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: June 2014

Study information

• Verified date: June 2019
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 46 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Drug:
• GA-arm, remifentanil
Remifentanil and propofol will be delivered intravenously via TCI pumps according to the "Marsh" and "Minto" algorithm
• RA-arm
Intrathecal (i.e. spinal) anesthesia with isobaric bupivacaine 15 mg administered intrathecally at L4-L5.

Locations

Country	Name	City	State
Sweden	Dept Orthopedic Surgey, Hässleholm Hospital, PO Box 351,	Hässleholm

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

References & 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. Review. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time Hrs Until the Patient Meets the Discharge Criteria From PACU	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	12 hrs
Primary	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	Post Operative Pain	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)	from end of surgey until 48 hrs later