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The objective of this study is to quantify the change in post-operative pain scores and narcotic requirements in women receiving pre and post-operative IV acetaminophen compared to placebo in women undergoing laparoscopic hysterectomy.
Gynecologic surgery has been revolutionized by the incorporation of minimally invasive techniques. Procedures that once resulted in multiple day hospital admissions are now being performed in outpatient surgery centers. Common factors that contribute to delayed discharge are inadequate postoperative pain control and increased nausea and vomiting. A multi-modal pain management approach is considered optimal at controlling postsurgical pain, which includes combining different analgesics that act in varying mechanisms. By using medications that act synergistically, the overall analgesia requirement can oftentimes be decreased.
Opioids have been found to be highly effective in controlling postoperative pain; however, are associated with dose-dependent risks including nausea, vomiting, constipation, urinary retention, sedation, and respiratory depression. Subsequently, non-opioid options are frequently desired in an attempt to minimize narcotic intake. In the United States, intravenous acetaminophen was approved by the US Food and Drug Administration (FDA) in November 2010 for the management of mild to moderate pain and the reduction of fever. Since this time, multiple studies have analyzed the role of intravenous acetaminophen in both acute and postoperative pain; however, none have been specific to laparoscopic hysterectomy. The primary study published evaluating intravenous acetaminophen in laparoscopic hysterectomies also included multiple other laparoscopic procedures from a variety of specialties including general surgery, urology, and urogynecology. In addition, the intravenous acetaminophen was started on average 19 hours after the conclusion of the case once the patient controlled analgesic was discontinued.
Improved postsurgical pain control achieved with intravenous acetaminophen may potentially lead to same day discharge after major laparoscopic gynecologic procedures. Same day discharge after laparoscopic hysterectomy has been shown to be a safe option with proper patient counseling and multi-modal pain medications. In addition, same day discharge is also associated with decreased health care expenditures. With continued efforts to cut hospital costs, the pressure to discharge patients earlier continues to be high.
The investigators propose that intravenous acetaminophen will improve post-operative pain control and decrease narcotic requirements for patients undergoing laparoscopic hysterectomies. Furthermore, The investigators expect to find decreased postsurgical nausea and vomiting and potentially quicker discharge to home. This could have a large impact on the field of gynecologic surgery as major procedures that once required overnight admission may now succeed at same day discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous IV acetaminophen | Experimental | The patients in the treatment arm will receive 1000mg of IV acetaminophen. |
|
| Normal Saline | Placebo Comparator | The patients in the placebo arm will receive normal saline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV acetaminophen | Drug | The patients in the treatment arm will receive 1000mg of IV acetaminophen. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain | The primary aim of this study is to compare overall post-surgical pain after hysterectomy as reported by the patients on a visual analog scale with a range of 0 to 10 where 0 is no pain at all and 10 is the worst pain that a person can imagine. Less pain is considered preferable to more pain. The theory is that patients who have intravenous acetaminophen will report less post-surgical pain. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Narcotic Medication Use | The secondary outcome is comparison of narcotic pain medical requirements within the first 24 hours after surgery. The hypothesis is that the intravenous acetaminophen group will require less narcotic medications than the placebo group. Narcotic use in this study will be calculated by converting all narcotics (fentanyl, dilaudid etc) into standardized units of morphine using well validated conversion tables. |
| Measure | Description | Time Frame |
|---|---|---|
| Having a Feeling of General Well-being at One Month | Quality of recovery will be evaluated through the use of the validated Quality of Recovery-40 questionnaire. The hypothesis is that the intravenous acetaminophen group will experience an increased quality of recovery as compared to the placebo group. | 4 weeks |
| Number of Participants Who Vomited Within 24 Hours of Operation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Noah Rindos, MD | Faculty | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magee Womens Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25680474 | Background | Gonzalez AM, Romero RJ, Ojeda-Vaz MM, Rabaza JR. Intravenous acetaminophen in bariatric surgery: effects on opioid requirements. J Surg Res. 2015 May 1;195(1):99-104. doi: 10.1016/j.jss.2015.01.004. Epub 2015 Jan 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intravenous IV Acetaminophen | The patients in the treatment arm will receive 1000mg of IV acetaminophen. IV acetaminophen |
| FG001 | Normal Saline | The patients in the placebo arm will receive normal saline. placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intravenous IV Acetaminophen | The patients in the treatment arm will receive 1000mg of IV acetaminophen. IV acetaminophen |
| BG001 | Normal Saline | The patients in the placebo arm will receive normal saline. placebo |
| 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 | Postoperative Pain | The primary aim of this study is to compare overall post-surgical pain after hysterectomy as reported by the patients on a visual analog scale with a range of 0 to 10 where 0 is no pain at all and 10 is the worst pain that a person can imagine. Less pain is considered preferable to more pain. The theory is that patients who have intravenous acetaminophen will report less post-surgical pain. | Posted | Mean | 95% Confidence Interval | units on a visual analog scale | 24 hours |
|
18 months
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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 | Intravenous IV Acetaminophen | The patients in the treatment arm will receive 1000mg of IV acetaminophen. IV acetaminophen |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| In patient hospitalization | Vascular disorders | Systematic Assessment | Postoperatively there was concern that the patient had undergone a cerebrovascular accident (CVA). She was withdrawn from the study and admitted to the intensive care unit. An extensive workup was performed with no evidence of any adverse event. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | Systematic Assessment | Patients who reported episode of vomiting at 24 hours |
The original protocol involved 154 patients with an expected rate of loss to follow up of 10%. Due to higher than expected loss to follow up the number of patients enrolled was increased to 190.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Noah Rindos | University of Pittsburgh Medical Center | (412) 641-8769 | rindosnb@upmc.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| placebo | Drug | The patients in the placebo arm will receive normal saline. |
|
|
| 24 hours |
A secondary aim of this study is to compare post-operative vomiting scores on post-operative day zero and one. Vomiting is reported as either having vomited or not vomited. The hypothesis is that the intravenous acetaminophen group will experience decreased vomiting compared with the placebo group. |
| 24 hours |
| Readiness for Discharge | Patient perception of satisfaction at time of discharge on post-operative day zero will be evaluated. The hypothesis is that intravenous acetaminophen group will experience increased satisfaction for discharge than the placebo group. | 24 hours |
| Nausea Before Surgery as Compared to After Surgery | A secondary aim of this study is to compare post-operative nausea on post-operative day zero and one as reported by the patients on a visual analog scale with a range of 0 to 10 where 0 is no nausea at all and 10 is the worst nausea that a person can imagine. Less nausea is considered preferable to more nausea. The hypothesis is that the intravenous acetaminophen group will experience decreased nausea compared with the placebo group. | 24 hours |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| 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 | Number | participants |
|
|
|
| Secondary | Narcotic Medication Use | The secondary outcome is comparison of narcotic pain medical requirements within the first 24 hours after surgery. The hypothesis is that the intravenous acetaminophen group will require less narcotic medications than the placebo group. Narcotic use in this study will be calculated by converting all narcotics (fentanyl, dilaudid etc) into standardized units of morphine using well validated conversion tables. | This analysis is of the total number of units of morphine used by each group over a 24 hour period that is composed of the amount of narcotics received in the operating room, recovery room as well as at 6,12, and 24 hours postoperatively. | Posted | Mean | 95% Confidence Interval | Morphine Equivalents | 24 hours |
|
|
|
| Other Pre-specified | Having a Feeling of General Well-being at One Month | Quality of recovery will be evaluated through the use of the validated Quality of Recovery-40 questionnaire. The hypothesis is that the intravenous acetaminophen group will experience an increased quality of recovery as compared to the placebo group. | The patients were asked to report their overall feeling of well being on a Visual Analog Scale one month after surgery. The scale has a range from 0 to 10 where a score of 0 would indicate the lowest (best) possible level of an outcome (pain, nausea etc) and a 10 would indicate the highest (worst) possible level. | Posted | Mean | 95% Confidence Interval | units on a scale | 4 weeks |
|
|
|
| Other Pre-specified | Number of Participants Who Vomited Within 24 Hours of Operation | A secondary aim of this study is to compare post-operative vomiting scores on post-operative day zero and one. Vomiting is reported as either having vomited or not vomited. The hypothesis is that the intravenous acetaminophen group will experience decreased vomiting compared with the placebo group. | Posted | Count of Participants | Participants | 24 hours |
|
|
|
|
| Other Pre-specified | Readiness for Discharge | Patient perception of satisfaction at time of discharge on post-operative day zero will be evaluated. The hypothesis is that intravenous acetaminophen group will experience increased satisfaction for discharge than the placebo group. | Patients who were asked about overall satisfaction with procedure at time of discharge using a Visual Analog Scale. The scale has a range from 0 to 10 where a score of 0 would indicate the lowest (best) possible level of an outcome (pain, nausea etc) and a 10 would indicate the highest (worst) possible level. | Posted | Mean | 95% Confidence Interval | units on a scale | 24 hours |
|
|
|
| Other Pre-specified | Nausea Before Surgery as Compared to After Surgery | A secondary aim of this study is to compare post-operative nausea on post-operative day zero and one as reported by the patients on a visual analog scale with a range of 0 to 10 where 0 is no nausea at all and 10 is the worst nausea that a person can imagine. Less nausea is considered preferable to more nausea. The hypothesis is that the intravenous acetaminophen group will experience decreased nausea compared with the placebo group. | Posted | Mean | 95% Confidence Interval | units on a scale | 24 hours |
|
|
|
|
| 0 |
| 91 |
| 1 |
| 91 |
| 10 |
| 91 |
| EG001 | Normal Saline | The patients in the placebo arm will receive normal saline. placebo | 0 | 92 | 0 | 92 | 11 | 92 |
|
|
| Pain | Nervous system disorders | Systematic Assessment | The patient had postoperative pain, withdrew from the study. The second dose of study medication was not given. |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment | Reports of nausea with level greater than 2 out of 10 at 24 hours. |
|
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| Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |