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

Sponsor:	Preben Kjolhede
Information provided by (Responsible Party):	Preben Kjolhede, 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 (MeSH nr: E04.950.300.399)	Drug: Bupivacain Drug: Morphine Drug: Propofol Drug: Fentanyl Drug: Rocuronbromid	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
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: Hysterectomy

Drug Information available for: Morphine sulfate Fentanyl Fentanyl Citrate Propofol Bupivacaine hydrochloride Bupivacaine

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 ]
Duration of hospital stay defined as time from start anesthesia to leaving the hospital

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 (Quality Adjusted Life Years). [ 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 ]

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

Arms	Assigned Interventions
Active Comparator: A Spinal anesthesia combined with intrathecal morphine. Spinal anesthesia applied in intervertebral space L3/L4 or L2/L3 with hyperbaric bupivacaine 20 mg and morphine 0.2 mg intrathecally. Sedation with propofol.	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
Active Comparator: B General anesthesia. General anesthesia induced with propofol, fentanyl and rocuronium, and maintained with propofol and oxygen in air. Rocuronium and fentanyl repeated when needed.	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

Arms

Assigned Interventions

Active Comparator: A

Spinal anesthesia combined with intrathecal morphine. Spinal anesthesia applied in intervertebral space L3/L4 or L2/L3 with hyperbaric bupivacaine 20 mg and morphine 0.2 mg intrathecally. Sedation with propofol.

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

Active Comparator: B

General anesthesia. General anesthesia induced with propofol, fentanyl and rocuronium, and maintained with propofol and oxygen in air. Rocuronium and fentanyl repeated when needed.

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

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 (hormone replacement therapy).
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
Eksjö Hospital
Eksjö, Sweden, 57581
Ryhov Hospital
Jönköping, Sweden, 55185
University Hospital
Linköping, Sweden, 58185
Vrinnevi Hospital
Norrköping, Sweden, 60182
Värnamo Hospital
Värnamo, Sweden, 33185

Sponsors and Collaborators

Preben Kjolhede

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:	Preben Kjolhede, Associate professor, 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

Keywords provided by University Hospital, Linkoeping:

Hospitalization
Postoperative care
Quality of Life

Health economy
Anesthesia. Spinal
Anesthesia, General

Additional relevant MeSH terms:

Anesthetics
Bupivacaine
Fentanyl
Propofol
Morphine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Narcotics
Analgesics
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on May 24, 2012