IV Acetaminophen for Postoperative Pain Analgesia After Laparoscopic Hysterectomy

• ClinicalTrials.gov Identifier: NCT02400580
• Recruitment Status: Completed
• First Posted: March 27, 2015
• Results First Posted: December 21, 2017
• Last Update Posted: June 13, 2018
• Sponsor: University of Pittsburgh
• Information provided by (Responsible Party): Noah Rindos, University of Pittsburgh

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pain	Drug: IV acetaminophen; Drug: placebo	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 183 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Intravenous Acetaminophen Versus Saline in Postoperative Analgesia After Laparoscopic Hysterectomy: A Randomized, Double Blind, Placebo Controlled Trial
• Study Start Date: February 2015
• Actual Primary Completion Date: September 2016
• Actual Study Completion Date: September 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intravenous IV acetaminophen; The patients in the treatment arm will receive 1000mg of IV acetaminophen.	Drug: IV acetaminophen; The patients in the treatment arm will receive 1000mg of IV acetaminophen.; Other Name: OFIRMEV
Placebo Comparator: Normal Saline; The patients in the placebo arm will receive normal saline.	Drug: placebo; The patients in the placebo arm will receive normal saline.; Other Name: Normal saline

Outcome Measures

Primary Outcome Measures :

1. Postoperative Pain [ Time Frame: 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 Outcome Measures :

1. Narcotic Medication Use [ Time Frame: 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 Outcome Measures:

1. Having a Feeling of General Well-being at One Month [ Time Frame: 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.
2. Number of Participants Who Vomited Within 24 Hours of Operation [ Time Frame: 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.
3. Readiness for Discharge [ Time Frame: 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.
4. Nausea Before Surgery as Compared to After Surgery [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United States, Pennsylvania

Magee Womens Hospital

Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

University of Pittsburgh

Investigators

• Principal Investigator: Noah Rindos, MD; Faculty

More Information

Publications:

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.

• Responsible Party: Noah Rindos, Fellow in Minimally Invasive Gynecology, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT02400580
• Other Study ID Numbers: PRO13110403
• First Posted: March 27, 2015
• Results First Posted: December 21, 2017
• Last Update Posted: June 13, 2018
• Last Verified: May 2018

Keywords provided by Noah Rindos, University of Pittsburgh:

Laparoscopic Hysterectomy; IV acetaminophen; Postoperative pain control; Surgery

Additional relevant MeSH terms:

Acetaminophen; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Antipyretics