Clinical trial NCT00527332: Effects of General Anesthesia and Spinal-Morphine Anesthesia on Recovery and Comfort After Benign Abdominal Hysterectomy
Official title: General Anesthesia Versus Spinal Anesthesia Combined With Intrathecal Morphine in Abdominal Hysterectomy for Benign Gynecological Diseases. A Randomized Open Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hysterectomy (MeSH nr: E04.950.300.399)
Keywords: Hospitalization
Postoperative care
Quality of Life
Health economy
Anesthesia. Spinal
Anesthesia, General
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2007-09-10
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Duration of Hospital Stay.
timeFrame: Within 6 months after surgery
Secondary outcomes:
measure: Occurrence and Degree of Postoperative Symptoms.
timeFrame: Within 6 months after the surgery
measure: Postoperative Consumption of Analgesics and Antiemetics.
timeFrame: Within 6 months after surgery
measure: Complications and Complication Rates.
timeFrame: Within 6 months after the surgery
measure: Quality of Life and QALYs (Quality Adjusted Life Years).
timeFrame: Within 6 months after the surgery
measure: Sick Leave.
timeFrame: Within 6 months after the surgery
measure: The Stress Coping Ability Impact on Postoperative Symptoms and Recovery.
timeFrame: Within 6 months after the surgery
measure: Health-related Economy.
timeFrame: Within 6 months after the surgery
Other outcomes:
Locations:
city: Eksjö
country: Sweden
facility: Eksjö Hospital
city: Jönköping
country: Sweden
facility: Ryhov Hospital
city: Linköping
country: Sweden
facility: University Hospital
city: Norrköping
country: Sweden
facility: Vrinnevi Hospital
city: Värnamo
country: Sweden
facility: Värnamo Hospital
Study officials:
affiliation: Department of Obstetrics and Gynecology, University Hospital, Linköping
name: Preben Kjölhede, MD, PhD
role: STUDY_CHAIR
affiliation: Department of Anesthesiology, University Hospital, Linköping
name: Lena Nilsson, MD, PhD
role: STUDY_DIRECTOR
affiliation: Department of Obstetrics and Gynecology, University Hospital, Linköping
name: Ninnie B. Wodlin, MD
role: STUDY_DIRECTOR
affiliation: Department of Ostetrics and Gynecology, Vrinnevi Hospital, Norrköping
name: Kenneth Krohn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anesthesiology, Vrinnevi Hospital, Norrköping
name: Lars Nordenberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Obstetrics and Gynecology, Ryhov Hospital, Jönköping
name: Mats D. Karlsson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anesthesiology, Ryhov Hospital, Jönköping
name: Veronica Annerhagen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Obstetrics and Gynecology, Värnamo Hospital
name: Christina Gunnervik, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anesthesiology, Värnamo Hospital
name: Magnus Trofast, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Obstetrics and Gynecology, Eksjö Hospital
name: Tomasz Stypa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anesthesiology, Eksjö Hospital
name: Albert Sundberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vårdtid, funktionskapacitet och sjukskrivningstider efter hysterektomi. Nationella data från 6503 patienter opererade år 2000 och 2001. Återrapport från Nationella registret för kvalitetsutveckling inom gynekologisk kirurgi (Gynop-registret), SFOG, 2003.
citation: Kehlet H, Wilmore DW. Multimodal strategies to improve surgical outcome. Am J Surg. 2002 Jun;183(6):630-41. doi: 10.1016/s0002-9610(02)00866-8.
citation: Wilmore DW, Kehlet H. Management of patients in fast track surgery. BMJ. 2001 Feb 24;322(7284):473-6. doi: 10.1136/bmj.322.7284.473. No abstract available.
citation: Moller C, Kehlet H, Friland SG, Schouenborg LO, Lund C, Ottesen B. Fast track hysterectomy. Eur J Obstet Gynecol Reprod Biol. 2001 Sep;98(1):18-22. doi: 10.1016/s0301-2115(01)00342-6.
citation: 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. doi: 10.1111/j.1471-0528.2006.01025.x.
citation: 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. doi: 10.1080/j.1600-0412.2003.00216.x.
citation: Kjolhede P, Langstrom P, Nilsson P, Wodlin NB, Nilsson L. The impact of quality of sleep on recovery from fast-track abdominal hysterectomy. J Clin Sleep Med. 2012 Aug 15;8(4):395-402. doi: 10.5664/jcsm.2032.
citation: Kjolhede P, Borendal Wodlin N, Nilsson L, Fredrikson M, Wijma K. Impact of stress coping capacity on recovery from abdominal hysterectomy in a fast-track programme: a prospective longitudinal study. BJOG. 2012 Jul;119(8):998-1006; discussion 1006-7. doi: 10.1111/j.1471-0528.2012.03342.x. Epub 2012 May 9.