Conditions: Hysterectomy (MeSH nr: E04.950.300.399)
Keywords: Hospitalization Postoperative care Quality of Life Health economy Anesthesia. Spinal Anesthesia, General
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 180
Healthy volunteers: no

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:

Arms:
arm 1: 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. arm 2: General anesthesia. General anesthesia induced with propofol, fentanyl and rocuronium, and maintained with propofol and oxygen in air. Rocuronium and fentanyl repeated when needed.

Interventions: intervention 1: Bupivacain intervention 2: Morphine intervention 3: Propofol intervention 4: Propofol intervention 5: Fentanyl intervention 6: Rocuronbromid intervention 7: Morphine
Intervention descriptions: intervention 1: 5 mg/mL, 4 mL intrathecally as a single dos intervention 2: 0.4 mg/mL; 0.5 mL intrathecally as a single dosage intervention 3: 2-5 mg/kg body weight/hours IV (intravenously) for sedation during the surgery intervention 4: 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 intervention 5: 100-200 microgram IV (intravenously) at start of anesthesia. 50-100 microgram IV on demand during surgery. intervention 6: 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 intervention 7: 5 mg is given IV (intravenously) before end of surgery

Protocol document: