Pain
Conditions
Keywords
Laparoscopic Hysterectomy, IV acetaminophen, Postoperative pain control, Surgery
Brief summary
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.
Detailed description
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.
Interventions
DRUGIV acetaminophen
The patients in the treatment arm will receive 1000mg of IV acetaminophen.
DRUGplacebo
The patients in the placebo arm will receive normal saline.
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Women aged 18-75 * Ability to read and write in English (our post-operative pain log is only available in English) * Planning a laparoscopic hysterectomy (includes total laparoscopic hysterectomy, laparoscopic supracervical hysterectomy, laparoscopically assisted vaginal hysterectomy, with or without salpingooophorectomy)
Exclusion criteria
* Answering yes to any of the following questions: Do you have a history of liver disease, kidney disease, hepatitis C, history of liver failure, greater than 3 drinks per day or being have you ever been told by your doctor that they should not take acetaminophen * History of cardiac arrhythmia * History of jaundice * Acute abdominal inflammatory or infectious process at time of surgery * Known malignancy at time of surgery * Known pregnancy at time of surgery * Plan to perform additional significant surgical procedure at the time of hysterectomy such as extensive excision of endometriosis on bowel or bladder or pelvic reconstructive procedure * \>6cm abdominal incision in order to remove the uterus at time of study-related hysterectomy * Regular use of narcotic pain medication (defined as use on most days of the week at any point in the past 3 months) * Allergy to acetaminophen * Women who weigh less than 50 kilograms on the day of surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain | 24 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Narcotic Medication Use | 24 hours | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Readiness for Discharge | 24 hours | 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. |
| Having a Feeling of General Well-being at One Month | 4 weeks | 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. |
| Number of Participants Who Vomited Within 24 Hours of Operation | 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. |
| Nausea Before Surgery as Compared to After Surgery | 24 hours | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intravenous IV Acetaminophen The patients in the treatment arm will receive 1000mg of IV acetaminophen.
IV acetaminophen | 91 |
| Normal Saline The patients in the placebo arm will receive normal saline.
placebo | 92 |
| Total | 183 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Normal Saline | Total | Intravenous IV Acetaminophen |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 92 Participants | 183 Participants | 91 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 92 participants | 183 participants | 91 participants |
| Sex: Female, Male Female | 92 Participants | 183 Participants | 91 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 | 0 / 91 | 0 / 92 |
| other Total, other adverse events | 10 / 91 | 11 / 92 |
| serious Total, serious adverse events | 1 / 91 | 0 / 92 |
Outcome results
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.
Time frame: 24 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intravenous IV Acetaminophen | Postoperative Pain | 3.55 units on a visual analog scale |
| Normal Saline | Postoperative Pain | 3.11 units on a visual analog scale |
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.
Time frame: 24 hours
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intravenous IV Acetaminophen | Narcotic Medication Use | 16.4 Morphine Equivalents |
| Normal Saline | Narcotic Medication Use | 18.4 Morphine Equivalents |
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.
Time frame: 4 weeks
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intravenous IV Acetaminophen | Having a Feeling of General Well-being at One Month | 4.11 units on a scale |
| Normal Saline | Having a Feeling of General Well-being at One Month | 4.31 units on a scale |
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.
Time frame: 24 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intravenous IV Acetaminophen | Nausea Before Surgery as Compared to After Surgery | 0.69 units on a scale |
| Normal Saline | Nausea Before Surgery as Compared to After Surgery | 0.85 units on a scale |
p-value: 0.508Fisher Exact
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.
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intravenous IV Acetaminophen | Number of Participants Who Vomited Within 24 Hours of Operation | 1 Participants |
| Normal Saline | Number of Participants Who Vomited Within 24 Hours of Operation | 2 Participants |
p-value: 0.517Fisher Exact
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.
Time frame: 24 hours
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intravenous IV Acetaminophen | Readiness for Discharge | 7.76 units on a scale |
| Normal Saline | Readiness for Discharge | 8.15 units on a scale |