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Completed

NCT Number: NCT00527332

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

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.

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Key information

Conditions

Hysterectomy (MeSH nr: E04.950.300.399)

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Eksjö Hospital, Eksjö, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacain

Drug

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

Other names: Marcain spinal tung., ATC-code: N01BB01

Morphine

Drug

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

Other names: Morfin Special, ATC-code: N02AA01

Propofol

Drug

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

Other names: ATC-code: N01AX10

Fentanyl

Drug

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

Other names: ATC-code:N01AH01

Rocuronbromid

Drug

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

Other names: Esmeron, ATC-code: M03AC09

Primary outcomes

  1. Duration of Hospital Stay.

    Time frame: Within 6 months after surgery

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

Secondary outcomes

  1. Occurrence and Degree of Postoperative Symptoms.

    Time frame: Within 6 months after the surgery

  2. Postoperative Consumption of Analgesics and Antiemetics.

    Time frame: Within 6 months after surgery

  3. Complications and Complication Rates.

    Time frame: Within 6 months after the surgery

  4. Quality of Life and QALYs (Quality Adjusted Life Years).

    Time frame: Within 6 months after the surgery

  5. Sick Leave.

    Time frame: Within 6 months after the surgery

  6. The Stress Coping Ability Impact on Postoperative Symptoms and Recovery.

    Time frame: Within 6 months after the surgery

  7. Health-related Economy.

    Time frame: Within 6 months after the surgery

Sponsors and collaborators

Lead sponsor

Preben Kjolhede

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Sep 10, 2007
Registry last updated
Jan 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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