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Effects of General Anesthesia and Spinal-Morphine Anesthesia on Recovery and Comfort After Benign Abdominal Hysterectomy
This study has been completed.
Study NCT00527332   Information provided by University Hospital, Linkoeping

First Received on September 7, 2007.   Last Updated on January 24, 2012   History of Changes
Results First Received: November 14, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Condition: Hysterectomy (MeSH nr: E04.950.300.399)
Interventions: Drug: Bupivacain
Drug: Morphine
Drug: Propofol
Drug: Fentanyl
Drug: Rocuronbromid

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Spinal Anesthesia Spinal anesthesia combined with intrathecal morphine
General Anesthesia General anesthesia

Participant Flow:   Overall Study
    Spinal Anesthesia     General Anesthesia  
STARTED     91     89  
COMPLETED     82     80  
NOT COMPLETED     9     9  
Protocol Violation                 4                 8  
Withdrew consent                 5                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Spinal Anesthesia Spinal anesthesia combined with intrathecal morphine
General Anesthesia General anesthesia

Baseline Measures
    Spinal Anesthesia     General Anesthesia     Total  
Number of Participants  
[units: participants]
 		  91     89     180  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     91     89     180  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  45.9  ± 5.5     46.0  ± 6.0     45.9  ± 5.7  
Gender  
[units: participants]
 		     
Female     91     89     180  
Male     0     0     0  
Region of Enrollment  
[units: participants]
 		     
Sweden     91     89     180  



  Outcome Measures

1.  Primary:   Duration of Hospital Stay.   [ Time Frame: Within 6 months after surgery ]
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2.  Secondary:   Occurrence and Degree of Postoperative Symptoms.   [ Time Frame: Within 6 months after the surgery ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Postoperative Consumption of Analgesics and Antiemetics.   [ Time Frame: Within 6 months after surgery ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Complications and Complication Rates.   [ Time Frame: Within 6 months after the surgery ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

5.  Secondary:   Quality of Life and QALYs (Quality Adjusted Life Years).   [ Time Frame: Within 6 months after the surgery ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Sick Leave.   [ Time Frame: Within 6 months after the surgery ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   The Stress Coping Ability Impact on Postoperative Symptoms and Recovery.   [ Time Frame: Within 6 months after the surgery ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Health-related Economy.   [ Time Frame: Within 6 months after the surgery ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Dr Preben Kjolhede
Organization: Deptartment of Obstetrics and Gynecology, University Hospital, Linköping, Sweden
phone: +46101030000 ext 3187
e-mail: Preben.Kjolhede@lio.se


Publications:
Kehlet H, Wilmore DW. Multimodal strategies to improve surgical outcome. Am J Surg. 2002 Jun;183(6):630-41. Review.
Wilmore DW, Kehlet H. Management of patients in fast track surgery. BMJ. 2001 Feb 24;322(7284):473-6. Review. No abstract available.
Møller C, Kehlet H, Friland SG, Schouenborg LO, Lund C, Ottesen B. Fast track hysterectomy. Eur J Obstet Gynecol Reprod Biol. 2001; 98(1): 18-22.
Persson P, Wijma K, Hammar M, Kjolhede P. Psychological wellbeing after laparoscopic and abdominal hysterectomy--a randomised controlled multicentre study. BJOG. 2006 Sep;113(9):1023-30.
Ellstrom MA, Astrom M, Moller A, Olsson JH, Hahlin M. A randomized trial comparing changes in psychological well-being and sexuality after laparoscopic and abdominal hysterectomy. Acta Obstet Gynecol Scand. 2003 Sep;82(9):871-5.


Responsible Party: Preben Kjolhede, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT00527332     History of Changes
Other Study ID Numbers: EudraCT nr 2006-002520-41
Study First Received: September 7, 2007
Results First Received: November 14, 2011
Last Updated: January 24, 2012
Health Authority: Sweden: Medical Products Agency





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