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Since there have been no published dose-response studies investigating the effective analgesic dose of ropivacaine for use in a TAP block for post-Cesarean delivery analgesia, the investigators propose a study primarily examining the effect on 24 hour post-Cesarean delivery opioid consumption of using either a placebo, 0.25% ropivacaine, 0.5% ropivacaine, or 0.75% ropivacaine for TAP blocks.
Cesarean delivery is the most commonly performed surgical procedure in the United States today, with over 1.2 million cases performed in 2005. One of the most important aspects of cesarean delivery is the provision of safe, effective postoperative analgesia for the mother, while simultaneously ensuring minimal side effects for both the mother and neonate. Studies have suggested that a multimodal approach to post-cesarean pain utilizing both intravenous, oral, and neuraxial opioids and non-steroidal anti-inflammatory drugs is highly effective in providing effective analgesia.
A significant component of post-cesarean pain is incisional pain from the Pfannenstiel incision on the anterior abdominal wall. The sensory supply to the skin, muscles, and parietal peritoneum of the anterior abdominal wall is derived from the anterior rami of T7-L1. After exiting the spinal column, these nerves proceed through the lateral abdominal wall within the transversus abdominal fascial plane, terminating in the anterior abdominal wall.
Recent studies have suggested that blocking these afferent sensory nerves with local anesthetics, as part of a multimodal postoperative pain regimen, provides superior pain relief in terms of decreased pain scores and morphine consumption for up to 48 hours postoperatively. The technique utilized for these studies employed a surface anatomical approach to the transversus abdominal fascial plane via the lumbar triangle of Petit, a technique validated in both cadaveric and radiologic studies. However, as ultrasonography has emerged as the "gold standard" for initiating many nerve blocks, reports have described the successful use of ultrasound imaging for initiation of transversus abdominis plane (TAP) blocks for both abdominal surgeries and cesarean deliveries.
In the published studies investigating the use of the TAP block for post-operative analgesia, either ropivacaine or bupivacaine was utilized in concentrations of 0.75% and 0.375%, respectively. Studies comparing ropivacaine with bupivacaine for use in interscalene, femoral, or sciatic nerve blocks have found no difference in terms of potency, time to onset or duration of postoperative analgesia between the two local anesthetics. Although no similar studies have been done with TAP blocks, one can assume that utilization of ropivacaine for this nerve block would yield similar results in terms postoperative analgesia. Moreover, the cardiotoxicity of ropivacaine has been shown to be significantly less than bupivacaine, making it a safer alternative for use in nerve blocks when used in high doses.
Risk factors for respiratory depression after the administration of neuraxial opioids in the non-obstetric population include morbid obesity and obstructive sleep apnea. For the obstetric population, a study of 856 patients revealed that all 8 patients who experienced respiratory depression after intrathecal morphine for cesarean delivery were markedly obese. Furthermore, the onset of respiratory depression after intrathecal morphine can occur up to 12 hours after administration, a time period when the patient is not being as closely monitored as she is during the 1:1 nursing care in the recovery room. Therefore, it is the investigators policy on the Labor and Delivery unit to not administer intrathecal morphine to any parturient with a history of obstructive sleep apnea or a BMI > 40 kg/m2. These patients often require intravenous opioid patient-controlled analgesia postoperatively, which has been shown to provide inferior pain relief and greater opioid consumption than neuraxial opioids. The current clinical standard is to administer the TAP block to those patients who have not received morphine in their neuraxial anesthetic. The TAP block offers a novel addition to the management of post-cesarean pain for this patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Placebo Comparator | TAP Block utilizing 15mL of 0.9% normal saline per side |
|
| Group 2 | Experimental | TAP Block utilizing 15ml of 0.2% ropivacaine per side |
|
| Group 3 | Experimental | TAP Block utilizing 15ml of 0.5% ropivacaine per side |
|
| Group 4 | Experimental | TAP Block utilizing 15ml of 0.75% ropivacaine per side |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.9% Normal Saline | Drug | The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side. |
| Measure | Description | Time Frame |
|---|---|---|
| Morphine Equivalents 0-24 Hours (Mgs) | Total dose of morphine equivalents (IV equivalent of morphine) taken by the participant 0-24 hours after completion of the TAP block. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Morphine Equivalents 24-72 Hours (Mgs) | Total dose of morphine equivalents (IV equivalent of morphine) taken by the participant 24-72 hours after completion of the TAP block. | 24-72 hours |
| Morphine Equivalents Total (Mgs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Walega, M.D. | Northwestern University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9495409 | Background | Cardoso MM, Carvalho JC, Amaro AR, Prado AA, Cappelli EL. Small doses of intrathecal morphine combined with systemic diclofenac for postoperative pain control after cesarean delivery. Anesth Analg. 1998 Mar;86(3):538-41. doi: 10.1097/00000539-199803000-00017. | |
| 14710063 | Background | Lowder JL, Shackelford DP, Holbert D, Beste TM. A randomized, controlled trial to compare ketorolac tromethamine versus placebo after cesarean section to reduce pain and narcotic usage. Am J Obstet Gynecol. 2003 Dec;189(6):1559-62; discussion 1562. doi: 10.1016/j.ajog.2003.08.014. |
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120 patients were randomized to one of four groups who received TAP blockade. Four patients subsequently were dropped from the study after randomization for pre-defined criteria. Substantive data was missing in one subject who was excluded from analysis. One patient received a morphine PCA instead of hydromorphone due to a drug shortage.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | TAP Block utilizing 15mL of 0.9% normal saline per side 0.9% Normal Saline: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side. |
| FG001 | Group 2 | TAP Block utilizing 15ml of 0.2% ropivacaine per side 0.2% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side. |
| FG002 | Group 3 | TAP Block utilizing 15ml of 0.5% ropivacaine per side 0.5% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side. |
| FG003 | Group 4 | TAP Block utilizing 15ml of 0.75% ropivacaine per side 0.75% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | TAP Block utilizing 15mL of 0.9% normal saline per side 0.9% Normal Saline: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side. |
| 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 | Morphine Equivalents 0-24 Hours (Mgs) | Total dose of morphine equivalents (IV equivalent of morphine) taken by the participant 0-24 hours after completion of the TAP block. | Posted | Median | Inter-Quartile Range | Morphine equivalents (mg) | 24 hours |
|
Two hours after TAP block
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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 | Group 1 | TAP Block utilizing 15mL of 0.9% normal saline per side 0.9% Normal Saline: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea 2 hours after TAP | Gastrointestinal disorders | Nausea | Systematic Assessment |
We did not evaluate TAP success by quantifying the area of cutaneous sensory blockade. We established baseline pain scores immediately prior to TAP blockade, although most blocks were performed with residual spinal blockade present.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edward Yaghmour | Northwestern University Feinberg School of Medicine | 312-695-0693 | edward.yaghmour@nm.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 27, 2015 | Jun 7, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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|
| 0.2% Ropivacaine | Drug | The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side. |
|
| 0.5% Ropivacaine | Drug | The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side. |
|
| 0.75% Ropivacaine | Drug | The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side. |
|
Total dose of morphine equivalents (IV equivalent of morphine) taken by the participant 0-72 hours after completion of the TAP block.
| 72 hours |
| Time to First PCA Request | The elapsed time in minutes of the first PCA (patient controlled analgesia) request in time (minutes) from the end of the TAP block. | Elapsed time in minutes |
| Pain Scores at Rest | Pain scores at rest ( 0 low 10 high) using an 11 point VRS (verbal pain scale) at the following hour time points, at the first request for patient controlled analgesia (PCA) then at 2,6,24,and 74 hours after the first request for PCA (patient controlled analgesia). | Request for first patient controlled analgesia then at 2,6,24,72 hours after initial PCA request |
| Pain Scores With Movement | Pain scores with movement ( 0 low 10 high) using an 11 point VRS (verbal pain scale) at the first request for patient controlled analgesia (PCA) then at 2,6,24,and 74 hours after the first request for PCA (patient controlled analgesia). | First PCA request then at 2,6,24,72 hours after first PCA request. |
| Pain Burden at Rest | Pain burden at rest calculated as area under the pain score * time (hr) curve 0-72 hours. | 72 hours |
| Pain Burden With Movement | Pain burden with movement calculated as area under the pain score * time (hr) curve 0-72 hours. | 72 hours |
| 11464348 | Background | Siddik SM, Aouad MT, Jalbout MI, Rizk LB, Kamar GH, Baraka AS. Diclofenac and/or propacetamol for postoperative pain management after cesarean delivery in patients receiving patient controlled analgesia morphine. Reg Anesth Pain Med. 2001 Jul-Aug;26(4):310-5. doi: 10.1053/rapm.2001.21828. |
| 18378742 | Background | Loos MJ, Scheltinga MR, Mulders LG, Roumen RM. The Pfannenstiel incision as a source of chronic pain. Obstet Gynecol. 2008 Apr;111(4):839-46. doi: 10.1097/AOG.0b013e31816a4efa. |
| 18165577 | Background | McDonnell JG, Curley G, Carney J, Benton A, Costello J, Maharaj CH, Laffey JG. The analgesic efficacy of transversus abdominis plane block after cesarean delivery: a randomized controlled trial. Anesth Analg. 2008 Jan;106(1):186-91, table of contents. doi: 10.1213/01.ane.0000290294.64090.f3. |
| 17179269 | Background | McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f. |
| 16418039 | Background | O'Donnell BD, McDonnell JG, McShane AJ. The transversus abdominis plane (TAP) block in open retropubic prostatectomy. Reg Anesth Pain Med. 2006 Jan-Feb;31(1):91. doi: 10.1016/j.rapm.2005.10.006. No abstract available. |
| 18211466 | Background | Walter EJ, Smith P, Albertyn R, Uncles DR. Ultrasound imaging for transversus abdominis blocks. Anaesthesia. 2008 Feb;63(2):211. doi: 10.1111/j.1365-2044.2007.05424.x. No abstract available. |
| BG001 | Group 2 | TAP Block utilizing 15ml of 0.2% ropivacaine per side 0.2% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side. |
| BG002 | Group 3 | TAP Block utilizing 15ml of 0.5% ropivacaine per side 0.5% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side. |
| BG003 | Group 4 | TAP Block utilizing 15ml of 0.75% ropivacaine per side 0.75% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| BMI (kg/m^2) | The BMI is the subjects weight in kilograms (kg) divided by his or her height in meters squared. | Median | Full Range | BMI (kg/m^2) |
|
| Estimated Gestational Age (EGA) | Estimated gestational age in weeks. | Median | Inter-Quartile Range | weeks |
|
| # previous Cesarean deliveries | 1 subject did not respond for saline group previous cesarean delivery | Count of Participants | Participants |
|
| Race/Ethnicity | Count of Participants | Participants |
|
| OG001 | Group 2 | TAP Block utilizing 15ml of 0.2% ropivacaine per side 0.2% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side. |
| OG002 | Group 3 | TAP Block utilizing 15ml of 0.5% ropivacaine per side 0.5% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side. |
| OG003 | Group 4 | TAP Block utilizing 15ml of 0.75% ropivacaine per side 0.75% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side. |
|
|
|
| Secondary | Morphine Equivalents 24-72 Hours (Mgs) | Total dose of morphine equivalents (IV equivalent of morphine) taken by the participant 24-72 hours after completion of the TAP block. | Posted | Median | Inter-Quartile Range | Morphine equivalents (mgs) | 24-72 hours |
|
|
|
| Secondary | Morphine Equivalents Total (Mgs) | Total dose of morphine equivalents (IV equivalent of morphine) taken by the participant 0-72 hours after completion of the TAP block. | Posted | Median | Inter-Quartile Range | Morphine equivalents (mgs) | 72 hours |
|
|
|
| Secondary | Time to First PCA Request | The elapsed time in minutes of the first PCA (patient controlled analgesia) request in time (minutes) from the end of the TAP block. | Posted | Mean | Inter-Quartile Range | Minutes | Elapsed time in minutes |
|
|
|
| Secondary | Pain Scores at Rest | Pain scores at rest ( 0 low 10 high) using an 11 point VRS (verbal pain scale) at the following hour time points, at the first request for patient controlled analgesia (PCA) then at 2,6,24,and 74 hours after the first request for PCA (patient controlled analgesia). | Posted | Median | Inter-Quartile Range | units on a scale | Request for first patient controlled analgesia then at 2,6,24,72 hours after initial PCA request |
|
|
|
| Secondary | Pain Scores With Movement | Pain scores with movement ( 0 low 10 high) using an 11 point VRS (verbal pain scale) at the first request for patient controlled analgesia (PCA) then at 2,6,24,and 74 hours after the first request for PCA (patient controlled analgesia). | Posted | Median | Inter-Quartile Range | units on a scale | First PCA request then at 2,6,24,72 hours after first PCA request. |
|
|
|
| Secondary | Pain Burden at Rest | Pain burden at rest calculated as area under the pain score * time (hr) curve 0-72 hours. | Posted | Median | Inter-Quartile Range | score on scale * (hr) | 72 hours |
|
|
|
| Secondary | Pain Burden With Movement | Pain burden with movement calculated as area under the pain score * time (hr) curve 0-72 hours. | Posted | Median | Inter-Quartile Range | pain score * time (hr) curve 72 hours | 72 hours |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 11 |
| 34 |
| EG001 | Group 2 | TAP Block utilizing 15ml of 0.2% ropivacaine per side 0.2% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side. | 0 | 32 | 0 | 32 | 8 | 32 |
| EG002 | Group 3 | TAP Block utilizing 15ml of 0.5% ropivacaine per side 0.5% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side. | 0 | 25 | 0 | 25 | 12 | 25 |
| EG003 | Group 4 | TAP Block utilizing 15ml of 0.75% ropivacaine per side 0.75% Ropivacaine: The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side. | 0 | 29 | 0 | 29 | 10 | 29 |
| Pruritus | Skin and subcutaneous tissue disorders | Pruritus | Systematic Assessment | Pruritus 2 hours after TAP block |
|
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D000813 |
| Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| 1 Cesarean Delivery |
|
| > 1 Cesarean Deliveries |
|
|
|
|
|
| 2 hous after first PCA request |
|
| 6 hours after first PCA request |
|
| 24 hours after first PCA request |
|
| 72 hours after first PCA reqest |
|
| 2 hous after first PCA request |
|
| 6 hours after first PCA request |
|
| 24 hours after first PCA request |
|
| 72 hours after first PCA reqest |
|