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Because of logistic and practical reasons.
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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
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This study compares the effect on postoperative pain of bolus administration of ropivacaine in Transversus abdominis plane catheter and continuous bupivacain-infusion in epidural catheters following open gynecologic surgery.The study is double blind. The hypothesis is that the effect of the two modes of pain treatment are equal.
Patients for open gynecologic surgery will all receive both an epidural catheter and bilateral transversus abdominis plane (:TAP) catheters. After randomization in to two groups the patients receive either 1) intermittent boluses of ropivacaine in the TAP-catheters and isotonic potassium chloride-infusion i the epidural catheters or 2) intermittent isotonic potassium chloride-boluses i the TAP-catheters and bupivacain-infusion in the epidural catheters.
The investigators record pain-score and consumption of opioids in the first 24 hours postoperatively as well as thermoanalgesia at dermatome-levels th10-th12.
The investigators assume that the effect on postoperative pain after open gynecologic surgery is equal in the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacain-infusion in epidural catheter | Active Comparator | Bupivacain-infusion in epidural catheter and intermittent isotonic potassium chloride bolus in transversus abdominis plane catheter. |
|
| Ropivacaine bolus in transversus abdominis plane catheter | Active Comparator | Intermittent ropivacaine bolus in bilateral transversus abdominis plane catheter and isotonic potassium chloride infusion in epidural catheter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine bolus in transversus abdominis plane catheter | Drug | Ropivacaine 7,5 mg/ml, 10-25 ml in each catheter, depending on patient weight, the total dose of ropivacaine is kept less than 3 mg/kg for every bolus. Bolus is given every 6 hours, the first bolus is given just after induction of general anesthesia and the last bolus after 24 hours. In the epidural catheter a bolus of 8 ml isotonic potassium chloride is given and an infusion of isotonic potassium chloride, 4-7 ml/t depending on patient height is started and runs for the first 24 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain-score on numerical rating scale | 4 hours after first bolus in tranversus abdominis catheters |
| Measure | Description | Time Frame |
|---|---|---|
| Administration of opioids | The first 24 hours after surgery. | |
| Pain-score on numerical rating scale | 8 hours after first bolus in tranversus abdominis catheters | |
| Measure | Description | Time Frame |
|---|---|---|
| Thermoanalgesia at dermatome-level th10-th12 | 4 hours after first bolus in TAP-catherter |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nils F Bjerregaard, M.D. | Aalborg University Hospital | Principal Investigator |
| Bodil S Rasmussen, M.D. + PhD | Aalborg Sygehus | Study Director |
| Lone Nikolajsen, M.D, PhD | Aarhus University Hospital | Study Chair |
| Thomas F Bendtsen, MD, PhD | Aarhus University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg Hospital | Aalborg | Region Nord | 9000 | Denmark |
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| Bupivacain-infusion in epidural catheter | Drug | Isotonic potassium chloride, 10-25 ml in each transversus abdominis catheter, depending on patient weight. Bolus is given every 6 hours, the first bolus is given just after induction of general anesthesia and the last bolus after 24 hours. In the epidural catheter a bolus of 8 ml bupivacaine 2,5 mg/ml is given and an infusion of isotonic potassium chloride, 4-7 ml/t depending on patient height is started and runs for the first 24 hours |
|
| Pain-score on numerical rating scale |
| 24 hours after first bolus in tranversus abdominis catheters |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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