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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00527332

Enrollment

180

Registered

2007-09-10

Start date

2007-03-31

Completion date

2009-12-31

Last updated

2012-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hysterectomy (MeSH nr: E04.950.300.399)

Keywords

Hospitalization, Postoperative care, Quality of Life, Health economy, Anesthesia. Spinal, Anesthesia, General

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.

Interventions

DRUGFentanyl

100-200 microgram IV (intravenously) at start of anesthesia. 50-100 microgram IV on demand during surgery.

DRUGBupivacain

5 mg/mL, 4 mL intrathecally as a single dos

DRUGMorphine

0.4 mg/mL; 0.5 mL intrathecally as a single dosage

DRUGPropofol

2-5 mg/kg body weight/hours IV (intravenously) for sedation during the surgery

DRUGRocuronbromid

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 60 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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
Occurrence and Degree of Postoperative Symptoms.	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
Sick Leave.	Within 6 months after the surgery

Countries

Sweden

Participant flow

Participants by arm

Arm	Count
Spinal Anesthesia Spinal anesthesia combined with intrathecal morphine	91
General Anesthesia General anesthesia	89
Total	180

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Protocol Violation	4	8
Overall Study	Withdrew consent	5	1

Baseline characteristics

Characteristic	General Anesthesia	Spinal Anesthesia	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	89 Participants	91 Participants	180 Participants
Age Continuous	46.0 years STANDARD_DEVIATION 6	45.9 years STANDARD_DEVIATION 5.5	45.9 years STANDARD_DEVIATION 5.7
Region of Enrollment Sweden	89 participants	91 participants	180 participants
Sex: Female, Male Female	89 Participants	91 Participants	180 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	17 / 91	16 / 89
serious Total, serious adverse events	7 / 91	10 / 89

Outcome results

Primary

Duration of Hospital Stay.

Duration of hospital stay defined as time from start anesthesia to leaving the hospital

Time frame: Within 6 months after surgery

Population: Participants who completed the study were analyzed

Arm	Measure	Value (MEDIAN)
Spinal Anesthesia	Duration of Hospital Stay.	46 Hours
General Anesthesia	Duration of Hospital Stay.	50 Hours

Secondary