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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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Osteoarthritis
Interventions Drug: GA-arm, remifentanil
Drug: RA-arm
Enrollment 120
Recruitment Details  
Pre-assignment Details  
Arm/Group Title RA-arm GA-arm, Remifentanil
Hide Arm/Group Description

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

placebo

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

GA-arm, remifentanil: Remifentanil and propofol will be delivered intravenously via TCI pumps according to the "Marsh" and "Minto" algorithm

Period Title: Overall Study
Started 60 60
Completed 60 60
Not Completed 0 0
Arm/Group Title RA-arm GA-arm, Remifentanil Total
Hide Arm/Group Description

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

placebo

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

GA-arm, remifentanil: Remifentanil and propofol will be delivered intravenously via TCI pumps according to the "Marsh" and "Minto" algorithm

Total of all reporting groups
Overall Number of Baseline Participants 60 60 120
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
40
  66.7%
40
  66.7%
80
  66.7%
>=65 years
20
  33.3%
20
  33.3%
40
  33.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 60 participants 120 participants
68  (9) 66  (8) 67  (8)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
Female 29 31 60
Male 31 29 60
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Sweden Number Analyzed 60 participants 60 participants 120 participants
60 60 120
1.Primary Outcome
Title Length of Hospital Stay
Hide Description 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
Time Frame Up to 4 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Two patients in the RA group were excluded because of the conversion to general anaesthesia.
Arm/Group Title RA-arm GA-arm, Remifentanil
Hide Arm/Group Description:

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

placebo

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

GA-arm, remifentanil: Remifentanil and propofol will be delivered intravenously via TCI pumps according to the "Marsh" and "Minto" algorithm

Overall Number of Participants Analyzed 58 60
Median (Inter-Quartile Range)
Unit of Measure: hours
30
(25 to 45)
26
(23 to 30)
2.Secondary Outcome
Title Post Operative Pain
Hide Description 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)
Time Frame from end of surgey until 48 hrs later
Hide Outcome Measure Data
Hide Analysis Population Description
Two patients in the RA group were excluded because of the conversion to general anaesthesia.
Arm/Group Title RA-arm GA-arm, Remifentanil
Hide Arm/Group Description:

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

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

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

GA-arm, remifentanil: Remifentanil and propofol will be delivered intravenously via TCI pumps according to the "Marsh" and "Minto" algorithm

Overall Number of Participants Analyzed 58 60
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
35
(20 to 50)
25
(0 to 35)
3.Other Pre-specified Outcome
Title Time Hrs Until the Patient Meets the Discharge Criteria From PACU
Hide Description 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
Time Frame 12 hrs
Hide Outcome Measure Data
Hide Analysis Population Description
Two patients in the RA group were excluded because of the conversion to general anaesthesia.
Arm/Group Title RA-arm GA-arm, Remifentanil
Hide Arm/Group Description:

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

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

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

GA-arm, remifentanil: Remifentanil and propofol will be delivered intravenously via TCI pumps according to the "Marsh" and "Minto" algorithm

Overall Number of Participants Analyzed 58 60
Median (Inter-Quartile Range)
Unit of Measure: hours
4
(3 to 5)
3
(2 to 4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title RA-arm GA-arm, Remifentanil
Hide Arm/Group Description

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

placebo

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

GA-arm, remifentanil: Remifentanil and propofol will be delivered intravenously via TCI pumps according to the "Marsh" and "Minto" algorithm

All-Cause Mortality
RA-arm GA-arm, Remifentanil
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)      0/60 (0.00%)    
Hide Serious Adverse Events
RA-arm GA-arm, Remifentanil
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/60 (0.00%)      0/60 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
RA-arm GA-arm, Remifentanil
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/60 (1.67%)      1/60 (1.67%)    
Cardiac disorders     
atrial fibrillation * [1]  1/60 (1.67%)  1 1/60 (1.67%)  1
*
Indicates events were collected by non-systematic assessment
[1]
atrial fibrillation
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Andreas Harsten
Organization: Region Skane
Phone: 46708870567
EMail: andreas.harsten@skane.se
Layout table for additonal information
Responsible Party: Andreas Harsten, Region Skane
ClinicalTrials.gov Identifier: NCT01733472    
Other Study ID Numbers: Hip-CPH-2013
Hässleholm2013 ( Other Identifier: Region Skåne )
First Submitted: November 20, 2012
First Posted: November 27, 2012
Results First Submitted: April 7, 2016
Results First Posted: March 18, 2019
Last Update Posted: June 19, 2019