Effects of General Anesthesia and Spinal-Morphine Anesthesia on Recovery and Comfort After Benign Abdominal Hysterectomy - Tabular View

Tracking Information

First Received Date ^ICMJE

September 7, 2007

Last Updated Date

July 1, 2009

Start Date ^ICMJE

March 2007

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Duration of hospital stay. [ Time Frame: Within 6 months after surgery ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Duration of hospital stay related to the hysterectomy procedure and postoperative complications. [ Time Frame: Within 6 months after surgery ]

Change History

Complete list of historical versions of study NCT00527332 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Occurrence and degree of postoperative symptoms. [ Time Frame: Within 6 months after the surgery ] [ Designated as safety issue: Yes ]
Postoperative consumption of analgesics and antiemetics. [ Time Frame: Within 6 months after surgery ] [ Designated as safety issue: No ]
Complications and complication rates. [ Time Frame: Within 6 months after the surgery ] [ Designated as safety issue: Yes ]
Quality of Life and QALYs. [ Time Frame: Within 6 months after the surgery ] [ Designated as safety issue: No ]
Sick leave. [ Time Frame: Within 6 months after the surgery ] [ Designated as safety issue: No ]
The stress coping ability impact on postoperative symptoms and recovery. [ Time Frame: Within 6 months after the surgery ] [ Designated as safety issue: No ]
Health-related economy. [ Time Frame: Within 6 months after the surgery ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Occurrence and degree of postoperative symptoms. [ Time Frame: Within 6 months after the surgery ]
Postoperative consumption of analgesics and antiemetics. [ Time Frame: Within 6 months after surgery ]
Complications and complication rates. [ Time Frame: Within 6 months after the surgery ]
Quality of Life and QALYs. [ Time Frame: Within 6 months after the surgery ]
Sick leave. [ Time Frame: Within 6 months after the surgery ]
The stress coping ability impact on postoperative symptoms and recovery. [ Time Frame: Within 6 months after the surgery ]
Health-related economy. [ Time Frame: Within 6 months after the surgery ]

Descriptive Information

Brief Title ^ICMJE

Effects of General Anesthesia and Spinal-Morphine Anesthesia on Recovery and Comfort After Benign Abdominal Hysterectomy

Official Title ^ICMJE

General Anesthesia Versus Spinal Anesthesia Combined With Intrathecal Morphine in Abdominal Hysterectomy for Benign Gynecological Diseases. A Randomized Open Controlled Study.

Brief Summary

The purpose of this study is to determine whether spinal anesthesia combined with intrathecal morphine in abdominal hysterectomy on benign gynecological indications gives better outcome concerning duration of hospital stay and postoperative patient comfort than general anesthesia.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Control:  Active Control
Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Open Label
Primary Purpose:  Supportive Care

Condition ^ICMJE

Hysterectomy

Intervention ^ICMJE

Drug: Bupivacain
5 mg/mL, 4 mL intrathecally as a single dos
Other Names:
- Marcain spinal tung.
- ATC-code: N01BB01
Drug: Morphine
0.4 mg/mL; 0.5 mL intrathecally as a single dosage
Other Names:
- Morfin Special
- ATC-code: N02AA01
Drug: Propofol
2-5 mg/kg body weight/hours IV (intravenously) for sedation during the surgery

Other Name: ATC-code: N01AX10
Drug: Propofol
Induction of anesthesia with 1-2 mg/kg body weight IV (intravenously). After intubation maintenance dosage of 6-10 mg/kg/hour IV during the surgery

Other Name: ATC-code: N01AX10
Drug: Fentanyl
100-200 microgram IV (intravenously) at start of anesthesia. 50-100 microgram IV on demand during surgery.

Other Name: ATC-code:N01AH01
Drug: Rocuronbromid
0.6 mg/kg body weight IV (intravenously) at induction of anesthesia. If additional muscle relaxation is needed during surgery 5-10 mg is injected IV. The drug is given only at induction of anesthesia and during surgery
Other Names:
- Esmeron
- ATC-code: M03AC09
Drug: Morphine
5 mg is given IV (intravenously) before end of surgery

Other Name: ATC-code: N02AA01

Study Arms / Comparison Groups

A: Active Comparator
Spinal anesthesia combined with intrathecal morphine
Interventions:
- Drug: Bupivacain
- Drug: Morphine
- Drug: Propofol
B: Active Comparator
General anesthesia
Interventions:
- Drug: Propofol
- Drug: Fentanyl
- Drug: Rocuronbromid
- Drug: Morphine

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

180

Estimated Completion Date

December 2009

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Female between 18 and 60 years of age.
Scheduled for abdominal hysterectomy - total or subtotal -on benign gynecological indication.
At least one ovary planned to be preserved at the hysterectomy.
Can understand and communicate in Swedish
Accept participation after written and verbal information and after signed informed consent.
Has supervision at home after discharge from hospital during the first couple of days and has access to a telephone.

Exclusion Criteria:

Contra-indications against spinal or general anesthesia or the standard dosage of the study drugs
ASA classification ≥ Class 3
Postmenopausal women without HRT.
Suspected gynecological malignancy
Previously undergone bilateral oophorectomy
Substantial physically disabled so that a normal recovery with early physical mobilization can not be anticipated.
Mentally or severly psychic disabled

Gender

Female

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Sweden

Administrative Information

NCT ID ^ICMJE

NCT00527332

Responsible Party

Preben Kjölhede, Dept of Obstetrics and Gynecology, University Hospital, 581 85 Linköping, Sweden

Study ID Numbers ^ICMJE

EudraCT nr 2006-002520-41

Study Sponsor ^ICMJE

University Hospital, Linkoeping

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:	Preben Kjölhede, MD, PhD	Department of Obstetrics and Gynecology, University Hospital, Linköping
Study Director:	Lena Nilsson, MD, PhD	Department of Anesthesiology, University Hospital, Linköping
Study Director:	Ninnie B. Wodlin, MD	Department of Obstetrics and Gynecology, University Hospital, Linköping
Principal Investigator:	Kenneth Krohn, MD	Department of Ostetrics and Gynecology, Vrinnevi Hospital, Norrköping
Principal Investigator:	Lars Nordenberg, MD	Department of Anesthesiology, Vrinnevi Hospital, Norrköping
Principal Investigator:	Mats D. Karlsson, MD	Department of Obstetrics and Gynecology, Ryhov Hospital, Jönköping
Principal Investigator:	Veronica Annerhagen, MD	Department of Anesthesiology, Ryhov Hospital, Jönköping
Principal Investigator:	Christina Gunnervik, MD	Department of Obstetrics and Gynecology, Värnamo Hospital
Principal Investigator:	Magnus Trofast, MD	Department of Anesthesiology, Värnamo Hospital
Principal Investigator:	Tomasz Stypa, MD	Department of Obstetrics and Gynecology, Eksjö Hospital
Principal Investigator:	Albert Sundberg, MD, PhD	Department of Anesthesiology, Eksjö Hospital

Information Provided By

University Hospital, Linkoeping

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP