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OpenTrials
Completed

NCT Number: NCT02026687

Recovery and Analgesia After Surgery for Gynecological Cancer

The purpose of the study is to compare epidural analgesia and intrathecal analgesia for explorative laparotomy through a middle-line incision for gynecological cancer in a fast track program to se if there is any difference in recovery. Length of stay is analyzed together with self-rate quality of life.

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Key information

Conditions

Gynecological Cancer

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital

Linköping, 581 85, Sweden

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women with gynecological cancer (suspected or verified) planned for explorative laparotomy through a middle-line incision with a curative purpose.
  • WHO performance status < 2.
  • American Society of Anesthesiologists class 1-2.
  • Women that understand and can express themselves in Swedish.
  • Women that after verbal and written information accept participation in the study and have signed an informed consent.

Exclusion criteria

  • Women where surgery is expected to include part/s, other than the abdominal surgery, where intrathecal or epidural analgesia is not expected to be effective
  • Women with contra indications for intrathecal or epidural anesthesia.
  • Women who are physically disabled and therefore nor expected to be mobilized on the day after surgery in the same way as non-disabled.
  • Women with a mental retardation that makes it impossible to fill in the relevant questionnaires or makes it impossible to understand the meaning of participation, or if it is ethically doubtful to include the woman.
  • Women with psychiatric or mental disorder that according to the responsible physician makes it unsuitable to participate in the study .

Treatment and study plan

Epidural

Drug

Intrathecal

Drug

Primary outcomes

  1. Length of Stay

    Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 days

    From day of surgery (Day 0) until discharge after surgery

Secondary outcomes

  1. Change in Quality of Life

    Time frame: Preoperatively and until 6 weeks after surgery

    The questionnaire Short Form with 36 questions "SF-36" will be used preoperatively and at 6 weeks after surgery. The SF-36 consists of eight scaled subscores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental Health) and two Component summary scores (physical Component summary scoer, mental component summary score). A score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

Other outcomes

  1. Change in Pain

    Time frame: Day of surgery (day 0) until 6 weeks after surgery

    Pain at rest will be assessed using a numeric rating scale from 0 (no pain) to 10 (worst imaginable pain). Pain is documented on the day of surgery (day 0), 3 times daily postoperative day 1, 2, 3, 4, 5, 6, 7, 14, 21, 28, 35 and 42.

    Scale: NRS Minimum value:0 Maximum value: 10. Higher scores indicate worse outcome.

Sponsors and collaborators

Lead sponsor

Lena Nilsson

Other

Registry information

Official study title

Will Intrathecal Analgesia Contribute to a Faster Recovery Compared With Epidural Analgesia After Open Surgery for Gynecological Cancer. An Open Controlled Randomized Study.

Acronym: Speed

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 3, 2014
Registry last updated
Sep 24, 2019

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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