General or Regional Anesthesia for Hip Surgery

A study testing GA-arm, remifentanil and RA-arm in people with Osteoarthritis, run by Region Skane at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 46 to 84 years
Conditions the study is for: Osteoarthritis
What is being tested?: GA-arm, remifentanil and RA-arm
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 1 siteSweden
Study dates: Jan 2013to Jun 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 46 to 84 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Sweden1 site

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

Other trials in Sweden

About this study

Official title: General Versus Intrathecal Anaesthesia for Patients Undergoing Elective Total Hip Arthroplasty

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

Read the 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

Conditions: Osteoarthritis
Being tested: GA-arm, remifentanil, RA-arm
Keywords: anaesthetic techniques, subarachnoid, analgesia
Medical subject headings: Osteoarthritis, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01733472
Study group	Role	What they receive
RA-arm	Placebo comparator	RA-arm: the patients in this arm will receive intrathecal anaesthesia consisting of bupivacaine 15 mg Receives: 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 Receives: Drug: GA-arm, remifentanil

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Up to 4 days after surgery

Secondary outcomes (1)

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)
Measured: from end of surgey until 48 hrs later

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013Jun 2014

First posted27 Nov 2012 (estimated)
Study startJan 2013
Primary completionFeb 2014
Study completionJun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for OsteoarthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01733472
Sponsor's protocol ID: Hip-CPH-2013
Other IDs: Hässleholm2013
Status last verified: Jun 2019
First submitted: 20 Nov 2012
Last updated: 19 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

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.
PubMed 18211990
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.
PubMed 2361330
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.
PubMed 9009936
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.
PubMed 25736216

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effects of Music During Walking on Pain and Muscle Activation in People With Chronic Pain Due to Knee Osteoarthritis
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Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
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Effects of Low-Load Blood Flow Restriction Resistance Training With and Without Hip Abductor Strengthening in Patients With Knee Osteoarthritis.(BFR)
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All Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: General Versus Intrathecal Anaesthesia for Patients Undergoing Elective Total Hip Arthroplasty
ClinicalTrials.gov ID: NCT01733472
Acronym / sponsor ID: Hip-CPH-2013
Conditions: Osteoarthritis
Keywords: anaesthetic techniques, subarachnoid, analgesia
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Region SkaneUniversity, hospital or other
Study start: Jan 2013
Primary completion: Feb 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 27 Nov 2012 (estimated)
Results: Posted 18 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

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:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
RA-arm	Placebo comparator	Drug: RA-armRA-arm: the patients in this arm will receive intrathecal anaesthesia consisting of bupivacaine 15 mg
GA-arm, remifentanil	Experimental	Drug: GA-arm, remifentanilGA-arm: patients in this arm will receive general anaesthesia consisting of Target Controlled Infusion (TCI) of remifentanil and propofol

Who may qualify

Ages: 46 to 84 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GA-arm, remifentanilAlso: GA: TCI consisting of remifentanil an propofolRemifentanil and propofol will be delivered intravenously via TCI pumps according to the "Marsh" and "Minto" algorithm	Drug	GA-arm, remifentanil
RA-armAlso: Regional anesthesiaIntrathecal (i.e. spinal) anesthesia with isobaric bupivacaine 15 mg administered intrathecally at L4-L5.	Drug	RA-arm

Primary outcome

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

1 secondary outcome

Post Operative Pain
Time frame: from end of surgey until 48 hrs later

Results and safety

Results posted to the registry on 18 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
RA-arm	60	60
GA-arm, Remifentanil	60	60

Primary outcome: Length of Hospital Stay

Time frame: Up to 4 days after surgery. Median (Inter-Quartile Range). Unit: hours

Measure	RA-arm n = 58	GA-arm, Remifentanil n = 60
Value	30 (25 to 45)	26 (23 to 30)

Population analysed: Two patients in the RA group were excluded because of the conversion to general anaesthesia.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RA-arm	0 of 60 (0%)	1 of 60 (1.7%)	0 of 60
GA-arm, Remifentanil	0 of 60 (0%)	1 of 60 (1.7%)	0 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 18211990Fowler 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.
Background: PubMed 2361330Marsh 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.
Background: PubMed 9009936Minto 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.
Background: PubMed 25736216Harsten 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.
Individual participant dataSharing planned: No

Related trials for Osteoarthritis

Recruiting
Outpatient Physiotherapy vs. mHealth Exercise and Self-Management for Knee Osteoarthritis (MOKneeTOR)
Knee Osteoarthristis
Not yet recruiting
Effects of Music During Walking on Pain and Muscle Activation in People With Chronic Pain Due to Knee Osteoarthritis
Knee Osteoarthritis
Recruiting
Radio- KO Radiotherapy for Knee Osteoarthritis Clinical Trial
Osteoarthritis, Knee
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Not yet recruiting
Effects of Low-Load Blood Flow Restriction Resistance Training With and Without Hip Abductor Strengthening in Patients With Knee Osteoarthritis.(BFR)
Knee Osteoarthritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Andreas Harsten, M.D. principal investigator

Region Skane

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing GA-arm, remifentanil and RA-arm in people with Osteoarthritis, run by Region Skane at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Length of Hospital Stay (time frame: Up to 4 days after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01733472, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2019.