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Post-operative pain management after C-section is an important topic as the number of elective c-sections increases each year. Pain is managed either by giving opioids or by using non-opioids. The purpose of this study is to evaluate the effectiveness of IV Acetaminophen in pain relief and its impact in the usage of post-operative opioid requirements and opioid associated complications. The hypothesis is that four doses of IV Acetaminophen in conjunction with intrathecal or epidural morphine given to the patients after c-section will reduce post-operative opioid requirements and opioid associated complications.
Most of the opioids used are centrally acting drugs like morphine or its derivatives. The most common adverse reactions related to systemic administration of opioids are sedation, itching, constipation and less commonly, respiratory depression. One of the other management strategies for the pain control is the use of non-steroidal anti-inflammatory drugs (NSAIDS). Frequent use of NSAIDS is also associated with complications, such as gastric ulcer and platelet dysfunction. When compared to other non-NSAIDS, IV acetaminophen is a relatively safer drug with quicker onset of action. In an earlier conducted study, the onset of action of analgesia for a bolus dose of IV acetaminophen is 3 minutes. IV acetaminophen is FDA approved for management of mild to moderate pain. An adverse reaction associated with the prolonged usage of IV acetaminophen is hepatic injury. The most common adverse events encountered during previous clinical trials were nausea, vomiting, headache and insomnia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV Acetaminophen | Experimental | IV form, total of 4 doses (each 1000 mg), each every 6th hourly to a maximum dose of 4000 mg in 24 hours. |
|
| Saline as placebo | Experimental | IV form, total 4 units, each given every 6th hourly in 24 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV Acetaminophen | Drug | 1gm IV. 1st dose at the cord clamping and 3 more doses given every 6th hourly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Requirements in Cesarean Section (C-section) Patient Population | 24 and 48 hours after Cesarean Section |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Score (VAS) Pain Score | Post-operative pain was assessed using VAS pain scores (0-10 scale) with 10 being the worst | every 6 hours for the first 24 hours after the c-section and there after every 8 hours until the patient is discharged or up to 48 hours |
| Percentage of Participants Reporting to be Wide Awake up to 72 Hours After the C-section |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Bernstein, MD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center- Weiler | The Bronx | New York | 10467 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32156175 | Derived | Bernstein J, Spitzer Y, Ohaegbulam K, Reddy S, Song J, Romanelli E, Nair S. The analgesic efficacy of IV acetaminophen for acute postoperative pain in C-section patients: a randomized, double-blind, placebo-controlled study. J Matern Fetal Neonatal Med. 2022 Mar;35(5):933-940. doi: 10.1080/14767058.2020.1735337. Epub 2020 Mar 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | IV Acetaminophen | IV form, total of 4 doses (each 1000 mg), each every 6th hourly to a maximum dose of 4000 mg in 24 hours. IV Acetaminophen: 1gm IV. 1st dose at the cord clamping and 3 more doses given every 6th hourly |
| FG001 | Saline as Placebo | IV form, total 4 units, each given every 6th hourly in 24 hours. Saline as placebo: 100ml saline IV. 1st dose of 100 ml at cord clamping and 3 more 100ml doses every 6th hourly. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IV Acetaminophen | IV form, total of 4 doses (each 1000 mg), each every 6th hourly to a maximum dose of 4000 mg in 24 hours. IV Acetaminophen: 1gm IV. 1st dose at the cord clamping and 3 more doses given every 6th hourly |
| BG001 | Saline as Placebo |
| 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 | Opioid Requirements in Cesarean Section (C-section) Patient Population | Posted | Mean | Standard Deviation | mg | 24 and 48 hours after Cesarean Section |
|
24 hours, 48 hours and up to one week after surgery
Serious and Other (Not Including Serious) Adverse Events
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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 | IV Acetaminophen | IV form, total of 4 doses (each 1000 mg), each every 6th hourly to a maximum dose of 4000 mg in 24 hours. IV Acetaminophen: 1gm IV. 1st dose at the cord clamping and 3 more doses given every 6th hourly |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
There may be unknown factors that could have biased the results of the study, pain tolerance is not measured in this study, surgeon variation in performing the surgery and lack of standardized post -operative pain management protocol.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Bernstein | Montefiore Medical Center | 718-920-4317 | JBernste@montefiore.org |
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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 |
|---|---|
| D000082 | Acetaminophen |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Saline as placebo | Other | 100ml saline IV. 1st dose of 100 ml at cord clamping and 3 more 100ml doses every 6th hourly. |
|
Sedation was assessed on a scale of 1-3 (1= wide awake, 2= sleepy but easily aroused, 3= sleepy and difficult to arouse). These assessments were made at the same time points as the pain assessments by the same research assistant. Score 1 is the only good outcome. |
| Percentage of Participants Reporting to be Wide Awake up to 72 hours after the C-section |
| "Percentage of Patients With Adverse Events After the Surgery | Subjects were specifically asked about adverse events such as nausea, vomiting, pruritus and breathing difficulties and information regarding their bowel movements. This information was collected on a scale of none, mild, moderate or severe. These are categorical outcomes. | every 6 hours for the first 24 hours after the c-section and there after every 8 hours until the patient is discharged or upto 72 hours. Finally, 1 week after discharge. |
| Number of Participants Using Patient-controlled Analgesia (PCA) Attempts | Data were not collected.The use of patient-controlled analgesia (PCA) pumps could have been utilized to standardize rescue medications. This would have allowed the collection of the proportion of subjects that required additional rescue medications. This was another possible endpoint that could have been evaluated. | every 6 hours for the first 24 hours after the c-section and there after every 8 hours until the patient is discharged or upto 72 hours. |
| Percentage of Participants That Were Re-Hospitalized 1 Week After Discharge | No patients were re hospitalized in the first 7 days | From time of discharge to 1 week after discharge |
| Pain Medication Usage ( NSAIDS) | Compare the percentage of patients using non-opioid pain medication at 24 hours, and 48 hours and had experienced any adverse events. | For the first 24 hours after the c-section until the patient is discharged or up to 48 hours |
IV form, total 4 units, each given every 6th hourly in 24 hours. Saline as placebo: 100ml saline IV. 1st dose of 100 ml at cord clamping and 3 more 100ml doses every 6th hourly. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Visual Analog Score (VAS) Pain Score | Post-operative pain was assessed using VAS pain scores (0-10 scale) with 10 being the worst | Posted | Mean | Standard Deviation | scores on a scale | every 6 hours for the first 24 hours after the c-section and there after every 8 hours until the patient is discharged or up to 48 hours |
|
|
|
| Secondary | Percentage of Participants Reporting to be Wide Awake up to 72 Hours After the C-section | Sedation was assessed on a scale of 1-3 (1= wide awake, 2= sleepy but easily aroused, 3= sleepy and difficult to arouse). These assessments were made at the same time points as the pain assessments by the same research assistant. Score 1 is the only good outcome. | Posted | Number | percentage of patients | Percentage of Participants Reporting to be Wide Awake up to 72 hours after the C-section |
|
|
|
| Secondary | "Percentage of Patients With Adverse Events After the Surgery | Subjects were specifically asked about adverse events such as nausea, vomiting, pruritus and breathing difficulties and information regarding their bowel movements. This information was collected on a scale of none, mild, moderate or severe. These are categorical outcomes. | Posted | Number | percentage of patients | every 6 hours for the first 24 hours after the c-section and there after every 8 hours until the patient is discharged or upto 72 hours. Finally, 1 week after discharge. |
|
|
|
| Secondary | Number of Participants Using Patient-controlled Analgesia (PCA) Attempts | Data were not collected.The use of patient-controlled analgesia (PCA) pumps could have been utilized to standardize rescue medications. This would have allowed the collection of the proportion of subjects that required additional rescue medications. This was another possible endpoint that could have been evaluated. | None of the participants used PCA pumps so no data could be collected for this outcome measure. PCA was not part of the standard of care at our hospital. | Posted | every 6 hours for the first 24 hours after the c-section and there after every 8 hours until the patient is discharged or upto 72 hours. |
|
|
| Secondary | Percentage of Participants That Were Re-Hospitalized 1 Week After Discharge | No patients were re hospitalized in the first 7 days | Posted | Number | percentage of patients | From time of discharge to 1 week after discharge |
|
|
|
| Secondary | Pain Medication Usage ( NSAIDS) | Compare the percentage of patients using non-opioid pain medication at 24 hours, and 48 hours and had experienced any adverse events. | Posted | Number | percentage of patients | For the first 24 hours after the c-section until the patient is discharged or up to 48 hours |
|
|
|
| 0 |
| 33 |
| 30 |
| 33 |
| EG001 | Saline as Placebo | IV form, total 4 units, each given every 6th hourly in 24 hours. Saline as placebo: 100ml saline IV. 1st dose of 100 ml at cord clamping and 3 more 100ml doses every 6th hourly. | 0 | 33 | 24 | 33 |
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Pruritis | Infections and infestations | Non-systematic Assessment |
|
| Breathing Difficulty | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| D012816 | Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| 12 hours after CS |
|
| 18 hours after CS |
|
| 24 hours after CS |
|
| 32 hours after CS |
|
| 40 hours after CS |
|
| 48 hours after CS |
|
| 24 hour itching |
|
| 24 hour breathing difficulty |
|