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Infiltration of a local anesthetic into the surgical wound is a simple method to strive to control postoperative pain after surgery. In the investigators institution, this method is used quite often. However, there is a controversy regarding the analgesic efficacy. Moreover, the cost of the single use elastomeric pump used with this procedure is clearly higher than the costs of other routinely used analgesic methods.
According to the investigators observations, infiltration of a local anesthetic into the surgical wound after caesarean section seems to reduce the need for rescue analgesics. However, the scientific evidence of the efficacy of this technique is weak. The investigators decided to conduct a prospective, controlled, randomised, double blind trial on this topic.
The hypothesis is that wound infiltration with local anesthetic will reduce postoperative pain and opioid consumption after caesarean section without major adverse effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine 0,75% | Active Comparator | Postoperative wound infusion 15 mg /h / 48h |
|
| NaCl 0,9% | Placebo Comparator | Postoperative wound infusion with NaCl 0,9% 2 ml /h /48h |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine 0,75% | Drug | Postoperative wound infusion 2 ml/ h/ 48h |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Demand of Rescue Analgesics (Oxycodone) | The amount of oxycodone required 48 hours after operation. Oxycodone was administered when the strength of pain is over 3 on numeric rating scale (NRS) 0-10. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Strength of Pain on Numerical Rating Scale (NRS) | Intensity of pain was recorded on a numerical rating scale (0-10), where higher scores mean more severe pain, during rest and when moving, for five time intervals (0-6 h, 6-12 h, 12-24 h, 24-36 h and 36-48 h); for each time interval, the highest recorded pain score was taken into account. | 48 hours, divided to five time intervals (0-6 h, 6-12 h, 12-24 h, 24-36 h and 36-48 h) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sakari Syväoja, MD | North Carelia CH, Department of Anesthesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Karelia Central hospital | Joensuu | 80880 | Finland |
Three patients were excluded after recruitment and randomisation, for the following reasons: For one patient, an emergency operation was needed before the scheduled operation time; for one patient, the hospital pharmacy was unable to provide the study drug in time, and for one patient, no study drug was initiated because of communication errors.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ropivacaine 0,75% | Postoperative wound infusion 15 mg /h / 48h Ropivacaine 0,75%: Postoperative wound infusion 2 ml/ h/ 48h |
| FG001 | NaCl 0,9% | Postoperative wound infusion with NaCl 0,9% 2 ml /h /48h NaCl 0,9%: Postoperative wound infusion 2 ml/h/48h |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ropivacaine 0,75% | Patients undergoing caesarean section under spinal anaesthesia Ropivacaine 0,75%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/ h/ 48h |
| BG001 | NaCl 0,9% |
| 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 | The Demand of Rescue Analgesics (Oxycodone) | The amount of oxycodone required 48 hours after operation. Oxycodone was administered when the strength of pain is over 3 on numeric rating scale (NRS) 0-10. | Posted | Mean | Standard Deviation | mg | 48 hours |
|
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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 | Ropivacaine 0,75% | Patients undergoing caesarean section under spinal anaesthesia Ropivacaine 0,75%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/ h/ 48h |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound dressings becoming unpleasantly wet, resulting in termination of the study drug infusion | Skin and subcutaneous tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matti Reinikainen | Kuopio University Hospital | +358447176681 | matti.reinikainen@kuh.fi |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| NaCl 0,9% |
| Drug |
Postoperative wound infusion 2 ml/h/48h |
|
| Postoperative Nausea and Vomiting (PONV) | The numbers of patients with at least mild nausea at any time post-operatively. | 48 hours |
Patients undergoing caesarean section under spinal anaesthesia
NaCl 0,9%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/h/48h
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight, kg | Mean | Standard Deviation | kg |
|
| Height, cm | Mean | Standard Deviation | cm |
|
| Dose of spinal bupivacaine, mg | Mean | Standard Deviation | mg |
|
| Length of operation, min | Mean | Standard Deviation | min |
|
|
|
|
| Secondary | Strength of Pain on Numerical Rating Scale (NRS) | Intensity of pain was recorded on a numerical rating scale (0-10), where higher scores mean more severe pain, during rest and when moving, for five time intervals (0-6 h, 6-12 h, 12-24 h, 24-36 h and 36-48 h); for each time interval, the highest recorded pain score was taken into account. | Posted | Median | Inter-Quartile Range | units on a scale | 48 hours, divided to five time intervals (0-6 h, 6-12 h, 12-24 h, 24-36 h and 36-48 h) |
|
|
|
|
| Secondary | Postoperative Nausea and Vomiting (PONV) | The numbers of patients with at least mild nausea at any time post-operatively. | Posted | Number | participants | 48 hours |
|
|
|
|
| 0 |
| 33 |
| 1 |
| 33 |
| EG001 | NaCl 0,9% | Patients undergoing caesarean section under spinal anaesthesia NaCl 0,9%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/h/48h | 0 | 34 | 2 | 34 |
| Smarting of the wound | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Smarting of the wound, necessitating termination of the study drug infusion |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Highest recorded pain scores at rest, 12-24 h |
|
| Highest recorded pain scores at rest, 24-36 h |
|
| Highest recorded pain scores at rest, 36-48 h |
|
| Highest recorded pain scores when moving, 0-6 h |
|
| Highest recorded pain scores when moving, 6-12 h |
|
| Highest recorded pain scores when moving, 12-24 h |
|
| Highest recorded pain scores when moving, 24-36 h |
|
| Highest recorded pain scores when moving, 36-48 h |
|
| Wilcoxon (Mann-Whitney) |
| 0.86 |
No adjustments for multiple comparisons |
| Superiority |
| Highest recorded pain scores at rest, 12-24 h | Wilcoxon (Mann-Whitney) | 0.66 | No adjustments for multiple comparisons | Superiority |
| Highest recorded pain scores at rest, 24-36 h | Wilcoxon (Mann-Whitney) | 0.79 | No adjustments for multiple comparisons | Superiority |
| Highest recorded pain scores at rest, 36-48 h | Wilcoxon (Mann-Whitney) | 0.20 | No adjustments for multiple comparisons | Superiority |
| Highest recorded pain scores when moving, 0-6 h | Wilcoxon (Mann-Whitney) | 0.36 | No adjustments for multiple comparisons | Superiority |
| Highest recorded pain scores when moving, 6-12 h | Wilcoxon (Mann-Whitney) | 0.43 | No adjustments for multiple comparisons | Superiority |
| Highest recorded pain scores when moving, 12-24 h | Wilcoxon (Mann-Whitney) | 0.68 | No adjustments for multiple comparisons | Superiority |
| Highest recorded pain scores when moving, 24-36 h | Wilcoxon (Mann-Whitney) | 0.37 | No adjustments for multiple comparisons | Superiority |
| Highest recorded pain scores when moving, 36-48 h | Wilcoxon (Mann-Whitney) | 0.06 | No adjustments for multiple comparisons | Superiority |