Post-operative Pain
Conditions
Keywords
opioid usage requirements, pain, IV acetaminophen, opioid usage, c-section
Brief summary
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.
Detailed description
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.
Interventions
DRUGIV Acetaminophen
1gm IV. 1st dose at the cord clamping and 3 more doses given every 6th hourly
OTHERSaline as placebo
100ml saline IV. 1st dose of 100 ml at cord clamping and 3 more 100ml doses every 6th hourly.
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Elective full term CS patients * Age 18 and above * ASA I-III
Exclusion criteria
* Allergic reaction to IV acetaminophen * Not able to understand and sign the research consent * Pregnancy induced hypertension or pre-eclampsia patients * Planned intensive care admission patients * Patients with severe hepatic impairment or active liver diseases (Two fold increase in any of the liver enzymes) * Patients with serum creatinine\>2mg/dl * For nursing mothers, any evidence of hepatic dysfunction of the new born
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Opioid Requirements in Cesarean Section (C-section) Patient Population | 24 and 48 hours after Cesarean Section |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting to be Wide Awake up to 72 Hours After the C-section | 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. |
| Percentage of Patients With Adverse Events After the Surgery | 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. | 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. |
| Visual Analog Score (VAS) Pain Score | 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 | Post-operative pain was assessed using VAS pain scores (0-10 scale) with 10 being the worst |
| Percentage of Participants That Were Re-Hospitalized 1 Week After Discharge | From time of discharge to 1 week after discharge | No patients were re hospitalized in the first 7 days |
| Pain Medication Usage ( NSAIDS) | For the first 24 hours after the c-section until the patient is discharged or up to 48 hours | Compare the percentage of patients using non-opioid pain medication at 24 hours, and 48 hours and had experienced any adverse events. |
| Number of Participants Using Patient-controlled Analgesia (PCA) Attempts | 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. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 33 |
| 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. | 33 |
| Total | 66 |
Baseline characteristics
| Characteristic | IV Acetaminophen | Saline as Placebo | Total |
|---|---|---|---|
| Age, Continuous | 31 Years STANDARD_DEVIATION 6 | 31 Years STANDARD_DEVIATION 5 | 31 Years STANDARD_DEVIATION 5.5 |
| Region of Enrollment United States | 33 participants | 33 participants | 66 participants |
| Sex: Female, Male Female | 33 Participants | 33 Participants | 66 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 30 / 33 | 24 / 33 |
| serious Total, serious adverse events | 0 / 33 | 0 / 33 |
Outcome results
Primary
Opioid Requirements in Cesarean Section (C-section) Patient Population
Time frame: 24 and 48 hours after Cesarean Section
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IV Acetaminophen | Opioid Requirements in Cesarean Section (C-section) Patient Population | 24 hours cumulative | 44 mg | Standard Deviation 23 |
| IV Acetaminophen | Opioid Requirements in Cesarean Section (C-section) Patient Population | 48 hours cumulative | 58 mg | Standard Deviation 20 |
| Saline as Placebo | Opioid Requirements in Cesarean Section (C-section) Patient Population | 24 hours cumulative | 48 mg | Standard Deviation 28 |
| Saline as Placebo | Opioid Requirements in Cesarean Section (C-section) Patient Population | 48 hours cumulative | 57 mg | Standard Deviation 22 |
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.
Time frame: 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.
Population: 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.
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.
Time frame: For the first 24 hours after the c-section until the patient is discharged or up to 48 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IV Acetaminophen | Pain Medication Usage ( NSAIDS) | 27 percentage of patients |
| Saline as Placebo | Pain Medication Usage ( NSAIDS) | 30.3 percentage of patients |
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.
Time frame: Percentage of Participants Reporting to be Wide Awake up to 72 hours after the C-section
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IV Acetaminophen | Percentage of Participants Reporting to be Wide Awake up to 72 Hours After the C-section | 95 percentage of patients |
| Saline as Placebo | Percentage of Participants Reporting to be Wide Awake up to 72 Hours After the C-section | 95 percentage of patients |
Secondary
Percentage of Participants That Were Re-Hospitalized 1 Week After Discharge
No patients were re hospitalized in the first 7 days
Time frame: From time of discharge to 1 week after discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IV Acetaminophen | Percentage of Participants That Were Re-Hospitalized 1 Week After Discharge | 0 percentage of patients |
| Saline as Placebo | Percentage of Participants That Were Re-Hospitalized 1 Week After Discharge | 0 percentage of patients |
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IV Acetaminophen | Percentage of Patients With Adverse Events After the Surgery | 24 hour nausea | 22 percentage of patients |
| IV Acetaminophen | Percentage of Patients With Adverse Events After the Surgery | 24 hour vomiting | 21 percentage of patients |
| IV Acetaminophen | Percentage of Patients With Adverse Events After the Surgery | 24 hour itching | 57 percentage of patients |
| IV Acetaminophen | Percentage of Patients With Adverse Events After the Surgery | 24 hour breathing difficulty | 9 percentage of patients |
| Saline as Placebo | Percentage of Patients With Adverse Events After the Surgery | 24 hour breathing difficulty | 6 percentage of patients |
| Saline as Placebo | Percentage of Patients With Adverse Events After the Surgery | 24 hour nausea | 27 percentage of patients |
| Saline as Placebo | Percentage of Patients With Adverse Events After the Surgery | 24 hour itching | 63 percentage of patients |
| Saline as Placebo | Percentage of Patients With Adverse Events After the Surgery | 24 hour vomiting | 27 percentage of patients |
Secondary
Visual Analog Score (VAS) Pain Score
Post-operative pain was assessed using VAS pain scores (0-10 scale) with 10 being the worst
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IV Acetaminophen | Visual Analog Score (VAS) Pain Score | 0 hr pain after CS | 2.2 scores on a scale | Standard Deviation 2.9 |
| IV Acetaminophen | Visual Analog Score (VAS) Pain Score | 12 hours after CS | 1.2 scores on a scale | Standard Deviation 1.9 |
| IV Acetaminophen | Visual Analog Score (VAS) Pain Score | 32 hours after CS | 3.1 scores on a scale | Standard Deviation 2.4 |
| IV Acetaminophen | Visual Analog Score (VAS) Pain Score | 6 hours after CS pain | 3.4 scores on a scale | Standard Deviation 2.6 |
| IV Acetaminophen | Visual Analog Score (VAS) Pain Score | 40 hours after CS | 2.0 scores on a scale | Standard Deviation 2.2 |
| IV Acetaminophen | Visual Analog Score (VAS) Pain Score | 18 hours after CS | 3.1 scores on a scale | Standard Deviation 2.7 |
| IV Acetaminophen | Visual Analog Score (VAS) Pain Score | 48 hours after CS | 3.2 scores on a scale | Standard Deviation 2.5 |
| IV Acetaminophen | Visual Analog Score (VAS) Pain Score | 24 hours after CS | 4.0 scores on a scale | Standard Deviation 3.2 |
| Saline as Placebo | Visual Analog Score (VAS) Pain Score | 48 hours after CS | 2.6 scores on a scale | Standard Deviation 2.1 |
| Saline as Placebo | Visual Analog Score (VAS) Pain Score | 0 hr pain after CS | 1.4 scores on a scale | Standard Deviation 2 |
| Saline as Placebo | Visual Analog Score (VAS) Pain Score | 6 hours after CS pain | 3.6 scores on a scale | Standard Deviation 2.5 |
| Saline as Placebo | Visual Analog Score (VAS) Pain Score | 12 hours after CS | 2.3 scores on a scale | Standard Deviation 2.7 |
| Saline as Placebo | Visual Analog Score (VAS) Pain Score | 18 hours after CS | 2.9 scores on a scale | Standard Deviation 3 |
| Saline as Placebo | Visual Analog Score (VAS) Pain Score | 24 hours after CS | 5.1 scores on a scale | Standard Deviation 2.1 |
| Saline as Placebo | Visual Analog Score (VAS) Pain Score | 32 hours after CS | 2.9 scores on a scale | Standard Deviation 2.3 |
| Saline as Placebo | Visual Analog Score (VAS) Pain Score | 40 hours after CS | 1.2 scores on a scale | Standard Deviation 1.8 |