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| Name | Class |
|---|---|
| University of Rostock | OTHER |
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The purpose of this study is to investigate adequate pain treatment for patients after cesarean. In this study oral opioids were compared to intravenous opioids as they are supposed to provide superior pain control.
Pain management after cesarean is an important topic for women. Pain during and after surgery is their greatest concern.
After surgery quick mobilization is important to take care of the newborn. When using a patient controlled analgesia (PCA) device mobilization is limited and women can not meet their expectations to take care of the newborn. Oral analgesia in comparison offers superior patient satisfaction.
This trial was conducted to investigate the effectiveness of both treatment options and improve patients pain management and overall content after cesarean.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxycodon | Experimental |
| |
| Patient controlled analgesia (PCA) device with Pritramid | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Oxycodon | Drug | Patients assigned to the oral analgesia group received 20mg oxycodon at fixed intervals: 2 hours (h) and between 12h and 14h after cesarean. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference of Pain Scores on the Visual Analog Scale | The primary outcome measure was the change in patients assessment of pain after cesarean (CS) from baseline. For pain assessment a visual analog scale (VAS) was used. Women were asked to quantify pain using an eleven point numerical rating score from 0 to 10, with 0 indicating no pain, and 10 the worst pain. Single value were calculated (averaged). | Pain level was evaluated before therapy (2h after CS), 12h, 24h, 32h, 40h, 48 and 72h after CS. |
| Measure | Description | Time Frame |
|---|---|---|
| Subgroups | Secondary Outcome Measures were to identify subgroups in benefit of either therapy. | 6 month |
| Side Effects | Evaluation of side effects |
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Study participation was offered to all pts. aged > 18 years in labor and delivery for elective or unplanned secondary cesarean in the 37th or higher week of gestation.
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Max Dieterich, MD | University of Rostock, Department of Obstetrics and Gynecology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rostock, Department of Obstetrics and Gynecology | Rostock | Mecklenburg-Vorpommern | 18055 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15715617 | Background | Stamer UM, Wiese R, Stuber F, Wulf H, Meuser T. Change in anaesthetic practice for Caesarean section in Germany. Acta Anaesthesiol Scand. 2005 Feb;49(2):170-6. doi: 10.1111/j.1399-6576.2004.00583.x. | |
| 16580284 | Background | Davis KM, Esposito MA, Meyer BA. Oral analgesia compared with intravenous patient-controlled analgesia for pain after cesarean delivery: a randomized controlled trial. Am J Obstet Gynecol. 2006 Apr;194(4):967-71. doi: 10.1016/j.ajog.2006.02.025. |
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Recruitment between July 2009 and November 2009. Of 1112 patients 257 met the inclusion criteria and 239 agreed to participate
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxycodon | Patients randomized to the oral analgesia group received 20mg oxycodone at fixed intervals at 2 and 12 hours after cesarean section (CS). |
| FG001 | Patient Controlled Device With Pritramid | Patients assigned to the Patient-controlled analgesia (PCA) group received a single use i.v. PCA device (2mg piritramide/ml 0.9% saline, Vygon, Medical Products, Aachen, Germany). A patient initiated i.v. bolus injection contained 1mg piritramide with a lock out interval of 5 minutes. The maximum dose was limited to 30mg piritramide equivalent to 40mg oxycodone total dose. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxycodon | Patients randomized to the oral analgesia group received 20mg oxycodone at fixed intervals at 2 and 12 hours after CS. |
| BG001 | Patient Controlled Device With Pritramid |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Difference of Pain Scores on the Visual Analog Scale | The primary outcome measure was the change in patients assessment of pain after cesarean (CS) from baseline. For pain assessment a visual analog scale (VAS) was used. Women were asked to quantify pain using an eleven point numerical rating score from 0 to 10, with 0 indicating no pain, and 10 the worst pain. Single value were calculated (averaged). | The sample size (intention to treat) was computed to detect a difference in VAS score at 24h of 1.2 (30% reduction) at a power of 80%, a two-sided significance level of 0.05. | Posted | Mean | Standard Deviation | VAS score at 24 hours | Pain level was evaluated before therapy (2h after CS), 12h, 24h, 32h, 40h, 48 and 72h after CS. |
|
1 month
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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 | Oxycodon | Patients randomized to the oral analgesia group received 20mg oxycodone at fixed intervals at 2 and 12 hours after CS. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Max Dieterich | University of Rostock | +493814401 | 4500 | max.dieterich@uni-rostock.de |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010892 | Pirinitramide |
| ID | Term |
|---|---|
| D007540 | Isonipecotic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |
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| Piritramid | Drug | Patients assigned to the PCA group received a single use intravenous PCA device (Vygon, Medical Products, Aachen, Germany) with a 30ml deposit of 9% sodium chloride solution containing 60mg piritramide. Bolus injection of 0.5ml was administered by the patient herself if needed, with a lock out interval of 5 minutes Patients assigned to the oral analgesia group received 20mg oxycodon at fixed intervals: 2 hours (h) and between 12h and 14h after cesarean. The PCA was discontinued after 24 hours or earlier if demanded. |
|
| 6 month |
| Mobilisation | Evaluation of time to post surgical mobilization | 6 month |
| Costs | Evaluation costs between groups | 6 month |
| 12638399 | Background | Gammaitoni AR, Galer BS, Bulloch S, Lacouture P, Caruso F, Ma T, Schlagheck T. Randomized, double-blind, placebo-controlled comparison of the analgesic efficacy of oxycodone 10 mg/acetaminophen 325 mg versus controlled-release oxycodone 20 mg in postsurgical pain. J Clin Pharmacol. 2003 Mar;43(3):296-304. doi: 10.1177/0091270003251147. |
| 16192541 | Background | Carvalho B, Cohen SE, Lipman SS, Fuller A, Mathusamy AD, Macario A. Patient preferences for anesthesia outcomes associated with cesarean delivery. Anesth Analg. 2005 Oct;101(4):1182-1187. doi: 10.1213/01.ane.0000167774.36833.99. |
| 22622852 | Derived | Dieterich M, Muller-Jordan K, Stubert J, Kundt G, Wagner K, Gerber B. Pain management after cesarean: a randomized controlled trial of oxycodone versus intravenous piritramide. Arch Gynecol Obstet. 2012 Oct;286(4):859-65. doi: 10.1007/s00404-012-2384-5. Epub 2012 May 24. |
Patients assigned to the PCA group received a single use i.v. PCA device (2mg piritramide/ml 0.9% saline, Vygon, Medical Products, Aachen, Germany). A patient initiated i.v. bolus injection contained 1mg piritramide with a lock out interval of 5 minutes. The maximum dose was limited to 30mg piritramide equivalent to 40mg oxycodone total dose.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Patient Controlled Device With Pritramid | Patients assigned to the PCA group received a single use i.v. PCA device (2mg piritramide/ml 0.9% saline, Vygon, Medical Products, Aachen, Germany). A patient initiated i.v. bolus injection contained 1mg piritramide with a lock out interval of 5 minutes. The maximum dose was limited to 30mg piritramide equivalent to 40mg oxycodone total dose. |
|
|
|
| Secondary | Subgroups | Secondary Outcome Measures were to identify subgroups in benefit of either therapy. | Not Posted | 6 month | Participants |
| Secondary | Side Effects | Evaluation of side effects | Not Posted | 6 month | Participants |
| Secondary | Mobilisation | Evaluation of time to post surgical mobilization | Not Posted | 6 month | Participants |
| Secondary | Costs | Evaluation costs between groups | Not Posted | 6 month | Participants |
| 0 |
| 113 |
| 0 |
| 113 |
| EG001 | Patient Controlled Device With Pritramid | Patients assigned to the PCA group received a single use i.v. PCA device (2mg piritramide/ml 0.9% saline, Vygon, Medical Products, Aachen, Germany). A patient initiated i.v. bolus injection contained 1mg piritramide with a lock out interval of 5 minutes. The maximum dose was limited to 30mg piritramide equivalent to 40mg oxycodone total dose. | 0 | 126 | 0 | 126 |
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| D006573 |
| Heterocyclic Compounds, 1-Ring |