Phase 4
N=180
Effects of General Anesthesia and Spinal-Morphine Anesthesia on Recovery and Comfort After Benign Abdominal Hysterectomy
Hysterectomy (MeSH nr: E04.950.300.399)
Bottom Line
View on ClinicalTrials.gov: NCT00527332 ↗Enrolled (actual)
180
Serious AEs
9.4%
Results posted
Dec 2011
Primary outcome: Primary: Duration of Hospital Stay. — 46; 50 Hours
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Bupivacain (Drug); Morphine (Drug); Propofol (Drug); Fentanyl (Drug); Rocuronbromid (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Preben Kjolhede
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Hospital Stay. |
46; 50 | — |
| SECONDARY Occurrence and Degree of Postoperative Symptoms. |
— | — |
| SECONDARY Postoperative Consumption of Analgesics and Antiemetics. |
— | — |
| SECONDARY Complications and Complication Rates. |
— | — |
| SECONDARY Quality of Life and QALYs (Quality Adjusted Life Years). |
— | — |
| SECONDARY Sick Leave. |
— | — |
| SECONDARY The Stress Coping Ability Impact on Postoperative Symptoms and Recovery. |
— | — |
| SECONDARY Health-related Economy. |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00527332). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.