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

Phase 4

Completed

• Conditions: Hysterectomy (MeSH nr: E04.950.300.399)
• Interventions: Drug: Bupivacain; Drug: Morphine; Drug: Fentanyl; Drug: Rocuronbromid; Drug: Propofol

• Registration Number: NCT00527332
• Lead Sponsor: Preben Kjolhede

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-09-07
• Study First Submitted QC: 2007-09-07
• Study First Posted: 2007-09-10
• Primary Completion: 2009-06
• Study Completion: 2009-12
• Results First Submitted: 2011-11-14
• Results First Submitted QC: 2011-11-14
• Results First Posted: 2011-12-21
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-24
• Last Update Posted: 2012-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Bupivacain	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.
B	Rocuronbromid	General anesthesia. General anesthesia induced with propofol, fentanyl and rocuronium, and maintained with propofol and oxygen in air. Rocuronium and fentanyl repeated when needed.
A	Morphine	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.
A	Propofol	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.
B	Propofol	General anesthesia. General anesthesia induced with propofol, fentanyl and rocuronium, and maintained with propofol and oxygen in air. Rocuronium and fentanyl repeated when needed.
B	Fentanyl	General anesthesia. General anesthesia induced with propofol, fentanyl and rocuronium, and maintained with propofol and oxygen in air. Rocuronium and fentanyl repeated when needed.
B	Morphine	General anesthesia. General anesthesia induced with propofol, fentanyl and rocuronium, and maintained with propofol and oxygen in air. Rocuronium and fentanyl repeated when needed.

Primary Outcome Measures

Name	Time	Method
Duration of Hospital Stay.	Within 6 months after surgery	Duration of hospital stay defined as time from start anesthesia to leaving the hospital

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Värnamo Hospital; 🇸🇪 Värnamo, Sweden

Eksjö Hospital; 🇸🇪 Eksjö, Sweden

Ryhov Hospital; 🇸🇪 Jönköping, Sweden

University Hospital; 🇸🇪 Linköping, Sweden

Vrinnevi Hospital; 🇸🇪 Norrköping, Sweden