General Anesthesia Versus Spinal Anesthesia Combined With Intrathecal Morphine in Abdominal Hysterectomy for Benign Gynecological Diseases. A Randomized Open Controlled Study.
Overview
- Phase
- Phase 4
- Intervention
- Bupivacain
- Conditions
- Hysterectomy (MeSH nr: E04.950.300.399)
- Sponsor
- Preben Kjolhede
- Enrollment
- 180
- Locations
- 5
- Primary Endpoint
- Duration of Hospital Stay.
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Preben Kjolhede
Associate professor
University Hospital, Linkoeping
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
Arms & Interventions
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.
Intervention: Bupivacain
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.
Intervention: Morphine
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.
Intervention: Propofol
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.
Intervention: Propofol
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.
Intervention: Fentanyl
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.
Intervention: Rocuronbromid
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.
Intervention: Morphine
Outcomes
Primary Outcomes
Duration of Hospital Stay.
Time Frame: Within 6 months after surgery
Duration of hospital stay defined as time from start anesthesia to leaving the hospital
Secondary Outcomes
- 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)
- Quality of Life and QALYs (Quality Adjusted Life Years).(Within 6 months after the surgery)
- 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)
- Sick Leave.(Within 6 months after the surgery)