Recovery and Analgesia After Surgery for Gynecological Cancer

Study Overview
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Brief Summary
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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.

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

Conditions
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Gynecological Cancer

Intervention / Treatment
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* Drug: Epidural
* Drug: Intrathecal


Participation Criteria
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Eligibility Criteria
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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 .

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Epidural analgesia<br>The epidural anesthesia is applied at a low thoracic level, primarily Th10-Th11. A bolus dose of fentanyl together with a continuous infusion of bupivacain 2.5 mg/ml, fentanyl 1.8 µg/ml and epinephrine 2.5 µg/ml is used during surgery. Infusion rate is chosen by the attending anesthetist. Postoperatively the epidural anesthesia is continued until the morning of the third postoperative day using bupivacain 1 mg/ml, fentanyl 2 µg/ml and epinephrine 2µg/ml. Infusion rate is set by the responsible physician, maximum rate is 10 ml/hour. | Drug: Epidural<br> <br> |
| Experimental: Intrathecal analgesia<br>The patient is given one intrathecal dose of plain bupivacaine (Marcain® spinal) 5 mg/ml, 15 mg together with morphine (Morphine Special®) 0,4 mg/ml, 0.2 mg and clonidine (Catapresan®) 150 µg/ml, 75 µg. The intrathecal mixture is given through a lumbal puncture at level L2/3, L3/4 or L4/5 before the induction of general anesthesia. | Drug: Intrathecal<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |