Gynecological Cancer
Conditions
Brief 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.
Interventions
DRUGEpidural
DRUGIntrathecal
Sponsors
Lena Nilsson
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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 .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain | 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. |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Epidural Analgesia 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.
Epidural | 40 |
| Intrathecal Analgesia 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.
Intrathecal | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | Intrathecal Analgesia | Total | Epidural Analgesia |
|---|---|---|---|
| Age, Continuous | 58.5 years STANDARD_DEVIATION 8.5 | 58.7 years STANDARD_DEVIATION 8.9 | 59.0 years STANDARD_DEVIATION 14.5 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Sweden | 40 participants | 80 participants | 40 participants |
| Sex: Female, Male Female | 40 Participants | 80 Participants | 40 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 17 / 40 | 14 / 40 |
| serious Total, serious adverse events | 2 / 40 | 7 / 40 |
Outcome results
Primary
Length of Stay
From day of surgery (Day 0) until discharge after surgery
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 4 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Epidural | Length of Stay | 4.3 days |
| Spinal | Length of Stay | 3.3 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.
Time frame: Preoperatively and until 6 weeks after surgery
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Epidural | Change in Quality of Life | SF-36 Physical component summary score baseline | 44 units on a scale |
| Epidural | Change in Quality of Life | SF-36 Physical component summary score day 42 | 39 units on a scale |
| Epidural | Change in Quality of Life | SF-36 mental component summary score baseline | 46 units on a scale |
| Epidural | Change in Quality of Life | SF-36 mental component summary score day 42 | 49 units on a scale |
| Spinal | Change in Quality of Life | SF-36 mental component summary score day 42 | 51 units on a scale |
| Spinal | Change in Quality of Life | SF-36 Physical component summary score baseline | 45 units on a scale |
| Spinal | Change in Quality of Life | SF-36 mental component summary score baseline | 46 units on a scale |
| Spinal | Change in Quality of Life | SF-36 Physical component summary score day 42 | 38 units on a scale |
Other Pre-specified
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.
Time frame: Day of surgery (day 0) until 6 weeks after surgery
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Epidural | Change in Pain | Pain at rest Day 2 | 1.5 units on a scale |
| Epidural | Change in Pain | Pain at rest Day 7 | 1.1 units on a scale |
| Epidural | Change in Pain | Pain at rest Day 4 | 1.4 units on a scale |
| Epidural | Change in Pain | Pain at rest Day 14 | 0.8 units on a scale |
| Epidural | Change in Pain | Pain at rest Day 1 | 1.6 units on a scale |
| Epidural | Change in Pain | Pain at rest Day 21 | 0.5 units on a scale |
| Epidural | Change in Pain | Pain at rest Day 5 | 1.1 units on a scale |
| Epidural | Change in Pain | Pain at rest Day 28 | 0.2 units on a scale |
| Epidural | Change in Pain | Pain at rest Day 3 | 2.9 units on a scale |
| Epidural | Change in Pain | Pain at rest Day 35 | 0.3 units on a scale |
| Epidural | Change in Pain | Pain at rest Day 6 | 1.0 units on a scale |
| Epidural | Change in Pain | Pain at rest Day 42 | 0.5 units on a scale |
| Epidural | Change in Pain | Pain at rest Day 0 | 1.5 units on a scale |
| Spinal | Change in Pain | Pain at rest Day 42 | 0.1 units on a scale |
| Spinal | Change in Pain | Pain at rest Day 0 | 2.7 units on a scale |
| Spinal | Change in Pain | Pain at rest Day 1 | 3.2 units on a scale |
| Spinal | Change in Pain | Pain at rest Day 2 | 2.1 units on a scale |
| Spinal | Change in Pain | Pain at rest Day 3 | 1.4 units on a scale |
| Spinal | Change in Pain | Pain at rest Day 4 | 1.6 units on a scale |
| Spinal | Change in Pain | Pain at rest Day 5 | 1.2 units on a scale |
| Spinal | Change in Pain | Pain at rest Day 6 | 1.1 units on a scale |
| Spinal | Change in Pain | Pain at rest Day 7 | 1.0 units on a scale |
| Spinal | Change in Pain | Pain at rest Day 14 | 0.7 units on a scale |
| Spinal | Change in Pain | Pain at rest Day 21 | 0.3 units on a scale |
| Spinal | Change in Pain | Pain at rest Day 28 | 0.2 units on a scale |
| Spinal | Change in Pain | Pain at rest Day 35 | 0.3 units on a scale |