Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The investigators' goal in this planned prospective, randomized, patient blinded study is to compare our standard of care as the control group to an experimental group in which patients receive preemptive IV acetaminophen dosing that is continued every 6 hours for a total of 8 doses in patients who have undergone major gynecologic surgery. The outcomes analyzed will include amount of rescue opioids required, time to return of bowel function, length of hospital stay, and patient satisfaction. The hypothesis is that the addition of IV acetaminophen will decrease the need for opioid rescue and thereby decrease the incidence of associated gastrointestinal side effects including nausea, vomiting, bloating, and constipation. The hope is that it will affect the final outcome of quicker return of bowel function, increased patient satisfaction, shortened hospital stay and prove to be an overall more effective postoperative pain management approach.
This is a patient-blinded prospective study in which patients that undergo major gynecologic surgery via an open abdominal approach will be randomized into two arms:
Outcomes that will be analyzed include the amount of opioids used; time to return of bowel function designated as passage of flatus; time to first bowel movement if it occurs while inpatient; duration of hospital stay; and patient symptoms and satisfaction at the 24 and 48 hour marks as well as at time of discharge.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental (Normal Saline) | Placebo Comparator | Morphine patient-controlled-anesthesia (PCA) for the initial 24 hours post-operation with a low-dose basal rate (0.5mg/hr) and patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn for pain and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay. Normal saline 100cc IV will be infused as placebo every 6 hours for a total of eight doses with the first dose being given at time of anesthesia induction. |
|
| Experimental (IV Acetaminophen) | Active Comparator | Morphine PCA for the initial 24 hours post-operation with low-dose basal rate (0.5mg/hr) with patient administered boluses prn. IV acetaminophen 1,000mg will be given every six hours for a total of eight doses with the first dose being given at time of anesthesia induction. Oral oxycodone from 24-48 hours post-operation will be used prn and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Normal saline (100cc) will be given IV as the placebo medication every six hours for a total of eight doses with the first dose being given at time of anesthesia induction. |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Rescue - 48 Hours | Mean number opioid rescue in the first 48 hours calculated by converting all opiates to intravenous morphine | First 48 hours including pre-operative and intra-operative medications |
| Measure | Description | Time Frame |
|---|---|---|
| Return of Bowel Function | Time to return of bowel function (passage of flatus) in hours | Duration of hospital stay (up to 7 days). |
| Patient Satisfaction - Pain Control at 24 Hours, 48 Hours, and Discharge |
Not provided
Inclusion Criteria:
-Female patients undergoing major gynecologic surgery via an open abdominal approach. The included surgeries would be exploratory laparotomy with or without removal of uterus, fallopian tubes, or ovaries.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Laura K Randolph, DO, MS | Aultman Health Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aultman Health Foundation | Canton | Ohio | 44720 | United States |
Not provided
68 participants were enrolled between December 2013 and May 2014 at local institution
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Experimental (Normal Saline) | Placebo: Normal saline (100cc) will be given IV as the placebo medication every six hours for a total of eight doses with the first dose being given at time of anesthesia induction. Morphine patient-controlled-anesthesia (PCA) for the initial 24 hours post-operation with a low-dose basal rate (0.5mg/hr) and patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn for pain and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay. |
| FG001 | Experimental (IV Acetaminophen) | IV acetaminophen: IV acetaminophen (1,000mg) will be given every six hours for a total of eight doses with the first dose being given at time of anesthesia induction. Morphine PCA for the initial 24 hours post-operation with low-dose basal rate (0.5mg/hr) with patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Experimental (Normal Saline) | Placebo: Normal saline (100cc) will be given IV as the placebo medication every six hours for a total of eight doses with the first dose being given at time of anesthesia induction. Morphine patient-controlled-anesthesia (PCA) for the initial 24 hours post-operation with a low-dose basal rate (0.5mg/hr) and patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn for pain and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay. |
| 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 Rescue - 48 Hours | Mean number opioid rescue in the first 48 hours calculated by converting all opiates to intravenous morphine | Posted | Mean | Standard Deviation | Milligrams of intravenous morphine equiv | First 48 hours including pre-operative and intra-operative medications |
|
Surgery to Discharge (up to 7 days)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental (Normal Saline) | Placebo: Normal saline (100cc) will be given IV as the placebo medication every six hours for a total of eight doses with the first dose being given at time of anesthesia induction. Morphine patient-controlled-anesthesia (PCA) for the initial 24 hours post-operation with a low-dose basal rate (0.5mg/hr) and patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn for pain and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | Systematic Assessment |
Not provided
Pain perception and tolerance is an individual characteristics that cannot be controlled. Other limitations include small sample size and reliance on participants to complete surveys at prescribed time.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Research Programs | Aultman Hospital | 330-363-7274 | mary.amos@aultman.com |
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| IV acetaminophen | Drug | IV acetaminophen (1,000mg) will be given every six hours for a total of eight doses with the first dose being given at time of anesthesia induction. |
|
|
Subjects will rate their overall satisfaction with pain control on a 5-point Likert scale: 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree
| At 24 hours 48 hours, and discharge (up to 7 days) |
| Patient Satisfaction - Nausea Control at 24 Hours, 48 Hours, and Discharge | Subjects will rate their overall satisfaction with nausea control on a 5-point Likert scale 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree | At 24 hours, 48 Hours, and Discharge (up to 7 days) |
| Patient Satisfaction - Bloating at 24 Hours, 48 Hours, and Discharge | Subjects will rate their overall satisfaction with bloating on a 5-point likert scale 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree | At 24 hours, 48 Hours, and Discharge (up to 7 days) |
| Patient Satisfaction - Pruritis at 24 Hours, 48 Hours, and Discharge | Subjects will rate their overall satisfaction with pruritis control on a 5-point likert scale 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree | At 24 hours, 48 Hours, and Discharge (up to 7 days) |
| Length of Stay | Mean length of post-operative stay in days | Surgery to discharge |
| Did not complete satisfaction surveys |
|
| BG001 | Experimental (IV Acetaminophen) | IV acetaminophen: IV acetaminophen (1,000mg) will be given every six hours for a total of eight doses with the first dose being given at time of anesthesia induction. Morphine PCA for the initial 24 hours post-operation with low-dose basal rate (0.5mg/hr) with patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 |
| Experimental (IV Acetaminophen) |
IV acetaminophen: IV acetaminophen (1,000mg) will be given every six hours for a total of eight doses with the first dose being given at time of anesthesia induction. Morphine PCA for the initial 24 hours post-operation with low-dose basal rate (0.5mg/hr) with patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay. |
|
|
|
| Secondary | Return of Bowel Function | Time to return of bowel function (passage of flatus) in hours | Only participants with documented return of bowel function prior to discharge were analyzed. | Posted | Mean | Standard Deviation | Hours | Duration of hospital stay (up to 7 days). |
|
|
|
|
| Secondary | Patient Satisfaction - Pain Control at 24 Hours, 48 Hours, and Discharge | Subjects will rate their overall satisfaction with pain control on a 5-point Likert scale: 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree | Participants who completed the pain satisfaction survey at 24 hours | Posted | Mean | Standard Deviation | score on a scale | At 24 hours 48 hours, and discharge (up to 7 days) |
|
|
|
|
| Secondary | Patient Satisfaction - Nausea Control at 24 Hours, 48 Hours, and Discharge | Subjects will rate their overall satisfaction with nausea control on a 5-point Likert scale 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree | Participants who completed the nausea control survey. | Posted | Mean | Standard Deviation | score on a scale | At 24 hours, 48 Hours, and Discharge (up to 7 days) |
|
|
|
|
| Secondary | Patient Satisfaction - Bloating at 24 Hours, 48 Hours, and Discharge | Subjects will rate their overall satisfaction with bloating on a 5-point likert scale 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree | Participants who completed the bloating satisfaction survey | Posted | Mean | Standard Deviation | score on a scale | At 24 hours, 48 Hours, and Discharge (up to 7 days) |
|
|
|
|
| Secondary | Patient Satisfaction - Pruritis at 24 Hours, 48 Hours, and Discharge | Subjects will rate their overall satisfaction with pruritis control on a 5-point likert scale 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree | Participants who completed the pruritus satisfaction survey | Posted | Mean | Standard Deviation | score on a scale | At 24 hours, 48 Hours, and Discharge (up to 7 days) |
|
|
|
|
| Secondary | Length of Stay | Mean length of post-operative stay in days | Participants experiencing adverse event leading to increased length of stay were not analyzed. | Posted | Mean | Standard Deviation | Days | Surgery to discharge |
|
|
|
|
| 0 |
| 34 |
| 2 |
| 34 |
| 0 |
| 34 |
| EG001 | Experimental (IV Acetaminophen) | IV acetaminophen: IV acetaminophen (1,000mg) will be given every six hours for a total of eight doses with the first dose being given at time of anesthesia induction. Morphine PCA for the initial 24 hours post-operation with low-dose basal rate (0.5mg/hr) with patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay. | 0 | 34 | 1 | 34 | 0 | 34 |
| Pulmonary Embolism | Blood and lymphatic system disorders | Systematic Assessment |
|
Not provided
Not provided
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| At Discharge |
|
| At Discharge |
|
| At Discharge |
|
| At Discharge |
|