Phase 4
Completed N=80
Recovery and Analgesia After Surgery for Gynecological Cancer
Gynecological Cancer
Source: ClinicalTrials.gov NCT02026687 ↗
Enrolled (actual)
80
Serious AEs
11.3%
Results posted
Sep 2019
Primary outcomePrimary: Length of Stay — 4.3; 3.3 days
◆ Published Evidence
Established
54citations · ~8 / year
Effect of intrathecal morphine and epidural analgesia on postoperative recovery after abdominal surgery for gynecologic malignancy: an open-label randomised 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.
Linked Publications
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Effect of intrathecal morphine and epidural analgesia on postoperative recovery after abdominal surgery for gynecologic malignancy: an open-label randomised trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Length of Stay |
4.3; 3.3 | — |
| SECONDARY Change in Quality of Life |
44; 45; 39; 38; 46; 46 | — |
Eligibility Criteria
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 .
Data sourced from ClinicalTrials.gov (NCT02026687) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.