Recovery and Analgesia After Surgery for Gynecological Cancer

Gynecological Cancer Clinical Trial

— Speed  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02026687
• Other study ID #: Speed
• Status: Completed
• Phase: Phase 4
• Start date: March 2014
• Est. completion date: May 2016

Study information

• Verified date: September 2019
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Gynecological Cancer

Intervention

Drug:
• Epidural

• Intrathecal

Locations

Country	Name	City	State
Sweden	University Hospital	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
Lena Nilsson

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Pain	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.	Day of surgery (day 0) until 6 weeks after surgery
Primary	Length of Stay	From day of surgery (Day 0) until discharge after surgery	Participants will be followed for the duration of hospital stay, an expected average of 4 days
Secondary	Change in Quality of Life	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.	Preoperatively and until 6 weeks after surgery