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

NCT00527332 | Completed Phase 4 Results DMC

• 1 other identifier: EudraCT nr 2006-002520-41
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 5

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.

Conditions

Hysterectomy (MeSH nr: E04.950.300.399)

Keywords

Hospitalization; Postoperative care; Quality of Life; Health economy; Anesthesia. Spinal; Anesthesia, General

Outcome Measures

Primary Outcomes (1)

• Duration of Hospital Stay.

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

  Within 6 months after surgery

Secondary Outcomes (7)

• Occurrence and Degree of Postoperative Symptoms.

  Within 6 months after the surgery

• Postoperative Consumption of Analgesics and Antiemetics.

  Within 6 months after surgery

• Complications and Complication Rates.

  Within 6 months after the surgery

• Quality of Life and QALYs (Quality Adjusted Life Years).

  Within 6 months after the surgery

• Sick Leave.

  Within 6 months after the surgery

Study Arms (2)

A

ACTIVE COMPARATOR

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; Drug: Morphine; Drug: Propofol

B

ACTIVE COMPARATOR

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; Drug: Fentanyl; Drug: Rocuronbromid; Drug: Morphine

Interventions

Bupivacain DRUG

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

Also known as: Marcain spinal tung., ATC-code: N01BB01

A

Morphine DRUG

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

Also known as: Morfin Special, ATC-code: N02AA01

A

Propofol DRUG

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

Also known as: ATC-code: N01AX10

A

Fentanyl DRUG

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

Also known as: ATC-code:N01AH01

B

Rocuronbromid DRUG

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

Also known as: Esmeron, ATC-code: M03AC09

B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Preben Kjolhede: lead

Study Sites (5)

Eksjö Hospital

Eksjö, 57581, Sweden

Location

Ryhov Hospital

Jönköping, 55185, Sweden

Location

University Hospital

Linköping, 58185, Sweden

Location

Vrinnevi Hospital

Norrköping, 60182, Sweden

Location

Värnamo Hospital

Värnamo, 33185, Sweden

Location

Related Publications (8)

• 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.

  BACKGROUND

• 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.

  PMID: 12095591 BACKGROUND

• 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.

  PMID: 11222424 BACKGROUND

• 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.

  PMID: 11516794 BACKGROUND

• 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.

  PMID: 16956334 BACKGROUND

• 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.

  PMID: 12911451 BACKGROUND

• 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.

  PMID: 22893770 DERIVED

• 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.

  PMID: 22568450 DERIVED

MeSH Terms

Interventions

Bupivacaine; Morphine; Propofol; Fentanyl; Rocuronium

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperidines; Heterocyclic Compounds, 1-Ring; Androstanols; Androstanes; Steroids; Fused-Ring Compounds

Results Point of Contact

• Title: Dr Preben Kjolhede
• Organization: Deptartment of Obstetrics and Gynecology, University Hospital, Linköping, Sweden

Preben.Kjolhede@lio.se

+46101030000

Study Officials

• Preben Kjölhede, MD, PhD

  Department of Obstetrics and Gynecology, University Hospital, Linköping

  STUDY CHAIR

• Lena Nilsson, MD, PhD

  Department of Anesthesiology, University Hospital, Linköping

  STUDY DIRECTOR

• Ninnie B. Wodlin, MD

  Department of Obstetrics and Gynecology, University Hospital, Linköping

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 7, 2007
• First Posted: September 10, 2007
• Study Start: March 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: December 1, 2009
• Last Updated: January 26, 2012
• Results First Posted: December 21, 2011

Record last verified: 2012-01

Locations

SE (5)