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| ID | Type | Description | Link |
|---|---|---|---|
| IWK REB 4518 |
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This study has been designed to determine if women undergoing cesarean delivery with spinal anesthesia and routine pain management who also have an additional ultrasound guided transversus abdominis plane (TAP)block using ropivacaine have better pain relief and a better quality of recovery than women who don't have the additional TAP block. Maximizing pain relief using ultrasound guided TAP blocks in addition to neuraxial opioids, NSAIDs, and acetaminophen may improve acute pain outcomes, reduce adverse side effects, and potentially reduce chronic pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.25% Ropivicaine | Experimental | 0.25% ropivicaine (maximum 1.5mg/kg) |
|
| Placebo | Placebo Comparator | 20ml saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline placebo | Drug | 20ml saline |
| |
| Ropivicaine |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome will be postoperative pain, measured by an NRS, the quality of recovery score (QoR) and a Self Assessment Diary in the first 24h postoperative period. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| NRS / QoR - 48 hour Opioid Consumption Side effects - nausea, sedation | 48 hours | |
| TAP block success rates and duration of block effect will be assessed using a patient diary completed every 2 hours while the patient is awake. | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dolores McKeen, MD MSc FRCPC | IWK Health Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IWK Health Centre | Halifax | Nova Scotia | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24764186 | Derived | McKeen DM, George RB, Boyd JC, Allen VM, Pink A. Transversus abdominis plane block does not improve early or late pain outcomes after Cesarean delivery: a randomized controlled trial. Can J Anaesth. 2014 Jul;61(7):631-40. doi: 10.1007/s12630-014-0162-5. Epub 2014 Apr 24. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Drug |
0.25% ropivicaine (maximum 1.5mg/kg) |
|
|
| Persistant pain outcomes will be assessed at 30 days and 6 months using 5-minute SF-36 health survey. | 6 months |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |