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

Condition(s) targeted: Hysterectomy

Intervention: Bupivacain (Drug); Morphine (Drug); Propofol (Drug); Propofol (Drug); Fentanyl (Drug); Rocuronbromid (Drug); Morphine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University Hospital, Linkoeping

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

Overall contact:
Preben Kjölhede, MD, PhD, Phone: +4613223187, Email: Preben.Kjolhede@lio.se

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.

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

Study design: Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Duration of hospital stay related to the hysterectomy procedure and postoperative complications.

Secondary outcome:

Occurrence and degree of postoperative symptoms.

Postoperative consumption of analgesics and antiemetics.

Complications and complication rates.

Quality of Life and QALYs.

Sick leave.

The stress coping ability impact on postoperative symptoms and recovery.

Health-related economy.

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Female.

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

Preben Kjölhede, MD, PhD, Phone: +4613223187, Email: Preben.Kjolhede@lio.se

University Hospital, Linköping 58185, Sweden; Recruiting
Preben Kjölhede, MD, PhD, Phone: +46132200, Ext: 3187, Email: Preben.Kjolhede@lio.se
Lena Nilsson, MD, PhD, Phone: +461322200, Ext: 1838, Email: Lena.Nilsson@lio.se
Ninnie B. Wodlin, MD, Principal Investigator

Vrinnevi Hospital, Norrköping 60182, Sweden; Recruiting
Kenneth Krohn, MD, Phone: +461122200, Ext: 3345, Email: Kenneth.Krohn@lio.se
Lars Nordenberg, MD, Phone: +4611222000, Ext: 2302, Email: Lars.Nordenberg@lio.se
Kenneth Krohn, MD, Principal Investigator

Ryhov Hospital, Jönköping 55185, Sweden; Recruiting
Mats D. Karlsson, MD, Phone: +4636321000, Ext: 1447, Email: Mats.D.Karlsson@lj.se
Veronica Annerhagen, MD, Phone: +4636321000, Ext: 2971, Email: Veronica.Annerhagen@lj.se
Mats D. Karlsson, MD, Principal Investigator

Värnamo Hospital, Värnamo 33185, Sweden; Recruiting
Christina Gunnervik, MD, Phone: +46370690000, Email: Christina.Gunnervik@lj.se
Magnus Trofast, MD, Phone: +46370690000, Email: Magnus.Trofast@lj.se
Christina Gunnevik, MD, Principal Investigator

Eksjö Hospital, Eksjö 57581, Sweden; Recruiting
Tomasz Stypa, MD, Phone: +4638135000, Email: Tomasz.Stypa@lj.se
Albert Sundberg, MD, PhD, Phone: +4638135000, Email: Albert.Sundberg@lj.se
Tomasz Stypa, MD, Principal Investigator

Related 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.

Starting date: March 2007
Ending date: September 2009
Last updated: June 4, 2008