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

Study 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.

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

Conditions
-----------------
Hysterectomy (MeSH nr: E04.950.300.399)

Intervention / Treatment
-----------------
* Drug: Bupivacain
* Drug: Morphine
* Drug: Propofol
* Drug: Propofol
* Drug: Fentanyl
* Drug: Rocuronbromid
* Drug: Morphine


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>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<br>* 5 mg/mL, 4 mL intrathecally as a single dos<br>* Other names: ATC-code: N01BB01;Drug: Morphine<br>* 0.4 mg/mL; 0.5 mL intrathecally as a single dosage<br>* Other names: ATC-code: N02AA01;Drug: Propofol<br>* 2-5 mg/kg body weight/hours IV (intravenously) for sedation during the surgery<br>* Other names: ATC-code: N01AX10;|
| Active Comparator: B<br>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<br>* 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<br>* Other names: ATC-code: N01AX10;Drug: Fentanyl<br>* 100-200 microgram IV (intravenously) at start of anesthesia. 50-100 microgram IV on demand during surgery.<br>* Other names: ATC-code:N01AH01;Drug: Rocuronbromid<br>* 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<br>* Other names: ATC-code: M03AC09;Drug: Morphine<br>* 5 mg is given IV (intravenously) before end of surgery<br>* Other names: ATC-code: N02AA01;|

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 | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hospitalization, Postoperative care, Quality of Life, Health economy, Anesthesia. Spinal, Anesthesia, General