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

Preben Kjolhede

Status and phase: Completed; Phase 4

Conditions: Hysterectomy (MeSH nr: E04.950.300.399)

Treatments: Drug: Propofol; Drug: Morphine; Drug: Fentanyl; Drug: Rocuronbromid; Drug: Bupivacain

Study type: Interventional

Funder types: Other

Identifiers

NCT00527332

EudraCT nr 2006-002520-41

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

A

Active Comparator group

Description:

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.

Treatment:

Drug: Bupivacain

Drug: Propofol

Drug: Morphine

Drug: Morphine

Drug: Propofol

B

Active Comparator group

Description:

General anesthesia. General anesthesia induced with propofol, fentanyl and rocuronium, and maintained with propofol and oxygen in air. Rocuronium and fentanyl repeated when needed.

Treatment:

Drug: Rocuronbromid

Drug: Propofol

Drug: Fentanyl

Drug: Morphine

Drug: Morphine

Drug: Propofol