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

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

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.

Study Overview

• Status: Completed
• Conditions: Hysterectomy (MeSH nr: E04.950.300.399)
• Intervention / Treatment: Drug: Bupivacain; Drug: Morphine; Drug: Propofol; Drug: Propofol; Drug: Morphine; Drug: Fentanyl; Drug: Rocuronbromid

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: ATC-code: N01AX10; 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 Names: ATC-code: N01AX10; Drug: Morphine; 5 mg is given IV (intravenously) before end of surgery; Other Names: ATC-code: N02AA01
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: 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 Names: ATC-code: N01AX10; 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 Names: ATC-code: N01AX10; Drug: Morphine; 5 mg is given IV (intravenously) before end of surgery; Other Names: ATC-code: N02AA01; Drug: Fentanyl; 100-200 microgram IV (intravenously) at start of anesthesia. 50-100 microgram IV on demand during surgery.; Other Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Hospital Stay.	Duration of hospital stay defined as time from start anesthesia to leaving the hospital	Within 6 months after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
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
The Stress Coping Ability Impact on Postoperative Symptoms and Recovery.	Within 6 months after the surgery
Health-related Economy.	Within 6 months after the surgery

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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. Erratum In: BJOG. 2012 Sep;119(10):1291.

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: September 7, 2007
• First Submitted That Met QC Criteria: September 7, 2007
• First Posted (Estimate): September 10, 2007

Study Record Updates

• Last Update Posted (Estimate): January 26, 2012
• Last Update Submitted That Met QC Criteria: January 24, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Quality of Life; Postoperative care; Hospitalization; Anesthesia, General; Health economy; Anesthesia. Spinal
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Propofol; Bupivacaine; Morphine
• Other Study ID Numbers: EudraCT nr 2006-002520-41