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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epidural analgesia | Active Comparator | 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. |
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| Intrathecal analgesia | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidural | Drug |
| ||
| Intrathecal |
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Linköping | 581 85 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30837253 | Derived | Kjolhede P, Bergdahl O, Borendal Wodlin N, Nilsson L. Effect of intrathecal morphine and epidural analgesia on postoperative recovery after abdominal surgery for gynecologic malignancy: an open-label randomised trial. BMJ Open. 2019 Mar 4;9(3):e024484. doi: 10.1136/bmjopen-2018-024484. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Length of Stay | From day of surgery (Day 0) until discharge after surgery | Posted | Median | Inter-Quartile Range | days | Participants will be followed for the duration of hospital stay, an expected average of 4 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Epidural | The EDA was performed by a low thoracic puncture. The epidural infusion included a bolus dose of fentanyl 50-100 µg and a bolus from a mixture of bupivacaine 2.4 mg/ml, adrenalin 2.4 µg/ml and fentanyl 1.8 µg/ml. For the EDA group, a continuous epidural infusion of a mixture of bupivacain 1 mg/ml + adrenalin 2µg/ml + fentanyl 2 µg/ml including the possibility of additional patient-controlled bolus doses was started postoperatively at the postoperative care unit and continued until the morning of the third postoperative day. The infusion rate, normally 4-8 ml/h, and bolus doses, normally 2 ml, were decided on by the responsible physician. The patients also had oral paracetamol 1330 mg three times daily, starting on the day of surgery. Oral oxycodone 10-20 mg twice daily and diclofenac 50 mg three times daily were added in the morning of the third postoperative day before removal of the epidural catheter according to the |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intensive care treatment | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deviation from normal postoperative cause | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Lena Nilsson | Dept of anaesthesia, Linköping University Hospital, Sweden | 0046101030000 | lena.nilsson@regionostergotland.se |
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| ID | Term |
|---|---|
| D007268 | Injections, Epidural |
| D007278 | Injections, Spinal |
| ID | Term |
|---|---|
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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|
| Preoperatively and until 6 weeks after surgery |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Spinal | The spinal group had an intrathecal combination of a single dose isobar bupivacaine 15 mg, morphine 0.2 mg and clonidine 75µg. The women in the ITM group received oral paracetamol 1330 mg and diclofenac 50 mg, both three times daily started on the day of surgery. Oxycodone 10-20 mg twice daily was added on the first postoperative day. |
|
|
| 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. | Posted | Median | Inter-Quartile Range | units on a scale | Preoperatively and until 6 weeks after surgery |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Day of surgery (day 0) until 6 weeks after surgery |
|
|
|
| 2 |
| 40 |
| 17 |
| 40 |
| EG001 | Spinal | The spinal group had an intrathecal combination of a single dose isobar bupivacaine 15 mg, morphine 0.2 mg and clonidine 75µg. The women in the ITM group received oral paracetamol 1330 mg and diclofenac 50 mg, both three times daily started on the day of surgery. Oxycodone 10-20 mg twice daily was added on the first postoperative day. | 7 | 40 | 14 | 40 |
| Surgical intervention | Surgical and medical procedures | Systematic Assessment |
|
| Pharmacological treatment | Surgical and medical procedures | Systematic Assessment |
|
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| SF-36 mental component summary score baseline |
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| SF-36 mental component summary score day 42 |
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| Pain at rest Day 2 |
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| Pain at rest Day 3 |
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| Pain at rest Day 4 |
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| Pain at rest Day 5 |
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| Pain at rest Day 6 |
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| Pain at rest Day 7 |
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| Pain at rest Day 14 |
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| Pain at rest Day 21 |
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| Pain at rest Day 28 |
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| Pain at rest Day 35 |
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| Pain at rest Day 42 |
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