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

Sponsor:	University Hospital, Linkoeping
Information provided by:	University Hospital, Linkoeping
ClinicalTrials.gov Identifier:	NCT00527332

Purpose

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.

Condition	Intervention	Phase
Hysterectomy	Drug: Bupivacain Drug: Morphine Drug: Propofol Drug: Fentanyl Drug: Rocuronbromid	Phase IV

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	General Anesthesia Versus Spinal Anesthesia Combined With Intrathecal Morphine in Abdominal Hysterectomy for Benign Gynecological Diseases. A Randomized Open Controlled Study.

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia Hysterectomy

Drug Information available for: Bupivacaine hydrochloride Bupivacaine Fentanyl Propofol

U.S. FDA Resources

Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	180
Study Start Date:	March 2007
Estimated Study Completion Date:	December 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Spinal anesthesia combined with intrathecal morphine	Drug: Bupivacain 5 mg/mL, 4 mL intrathecally as a single dos Drug: Morphine 0.4 mg/mL; 0.5 mL intrathecally as a single dosage Drug: Propofol 2-5 mg/kg body weight/hours IV (intravenously) for sedation during the surgery
B: Active Comparator General anesthesia	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 Drug: Fentanyl 100-200 microgram IV (intravenously) at start of anesthesia. 50-100 microgram IV on demand during surgery. 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 Drug: Morphine 5 mg is given IV (intravenously) before end of surgery

Arms

Assigned Interventions

A: Active Comparator

Spinal anesthesia combined with intrathecal morphine

Drug: Bupivacain

5 mg/mL, 4 mL intrathecally as a single dos

Drug: Morphine

0.4 mg/mL; 0.5 mL intrathecally as a single dosage

Drug: Propofol

2-5 mg/kg body weight/hours IV (intravenously) for sedation during the surgery

B: Active Comparator

General anesthesia

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

Drug: Fentanyl

100-200 microgram IV (intravenously) at start of anesthesia. 50-100 microgram IV on demand during surgery.

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

Drug: Morphine

5 mg is given IV (intravenously) before end of surgery

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00527332

Locations

Sweden
University Hospital
Linköping, Sweden, 58185
Vrinnevi Hospital
Norrköping, Sweden, 60182
Ryhov Hospital
Jönköping, Sweden, 55185
Värnamo Hospital
Värnamo, Sweden, 33185
Eksjö Hospital
Eksjö, Sweden, 57581

Sponsors and Collaborators

University Hospital, Linkoeping

Investigators

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

More Information

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:	Dept of Obstetrics and Gynecology, University Hospital, 581 85 Linköping, Sweden ( Preben Kjölhede )
Study ID Numbers:	EudraCT nr 2006-002520-41
Study First Received:	September 7, 2007
Last Updated:	July 1, 2009
ClinicalTrials.gov Identifier:	NCT00527332 History of Changes
Health Authority:	Sweden: Medical Products Agency

Keywords provided by University Hospital, Linkoeping:

Hospitalization
Postoperative care
Quality of Life

Health economy
Anesthesia. Spinal
Anesthesia, General

Additional relevant MeSH terms:

Anesthetics, Intravenous
Morphine
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Anesthetics, Local
Anesthetics, General

Sensory System Agents
Therapeutic Uses
Hypnotics and Sedatives
Bupivacaine
Analgesics
Peripheral Nervous System Agents
Propofol
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 08, 2010