Perioperative Systemic Acetaminophen to Improve Postoperative Quality of Recovery After Ambulatory Breast Surgery

• ClinicalTrials.gov Identifier: NCT01852955
• Recruitment Status: Completed
• First Posted: May 14, 2013
• Results First Posted: March 14, 2016
• Last Update Posted: March 14, 2016
• Sponsor: Northwestern University
• Information provided by (Responsible Party): Gildasio De Oliveira, Northwestern University

Study Description

Brief Summary:

Recent evidence demonstrates that perioperative pain continues to be poorly managed among ambulatory surgical patients. More importantly, few interventions that minimize postoperative pain have also shown to improve patient overall quality of post-surgical recovery. Ketorolac has been used to minimize perioperative pain despite the lack of evidence for its use when administered as a single dose preventive strategy.Ketorolac has also been associated with a higher incidence of perioperative hematomas and the need for surgical re-exploration after breast surgery.

Systemic acetaminophen has become recently available in The United States. In contrast to ketorolac, systemic acetaminophen has not been reported to have adverse side effects on patients undergoing breast surgery. Although evidence suggests that a single dose perioperative acetaminophen reduces postoperative pain, it remains unknown if a single dose intravenous acetaminophen improves postoperative quality of recovery after ambulatory surgery.

The main objective of the current investigation is to evaluate the effect of a single dose systemic acetaminophen on postoperative quality of recovery after ambulatory breast surgery. We also seek to determine if systemic acetaminophen would decrease postoperative pain and the time to hospital discharge in the same population.

Significance: The current project evaluates a potential intervention to improve perioperative pain and recovery after ambulatory breast surgery. Postoperative pain in the ambulatory surgical patients has been shown consistently to be poorly managed.

Condition or disease	Intervention/treatment	Phase
Pain	Drug: IV acetaminophen; Drug: Placebo	Not Applicable

Detailed Description:

Patients will be recruited up to the day of surgery. They will be then randomized using a computer generated table of random numbers to two groups: Group A (IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure) and Group B (placebo group-same volume of saline solution administered in the same fashion).This dose has been commonly used in other studies involving IV acetaminophen.6 Both drugs will be identical and will be prepared by hospital pharmacy. After placement of standard ASA monitors, induction will be performed with 0.1mcg/kg/min of remifentanil IV, propofol 1.5-2.5 mg/kg IV and succinylcholine 1-2 mg/kg IV. Tracheal intubation will be performed using a MAC 3 blade and a size 7 endotracheal tube. Maintenance will be achieved with remifentanil infusion titrated to keep the blood pressure within 20% of baseline values and sevoflurane titrated to keep a bispectral index monitor between 40 and 60. Patients will receive ondansetron 4mg IV and dexamethasone 4 mg IV for postoperative nausea and vomiting prophylaxis. In the recovery room patients will receive hydromorphone IV in divided doses to keep pain <4/10(scale where 0 means no pain and 10 is the worst pain) and metoclopramide 10 mg IV as rescue antiemetic. Data will be collected by a research assistant blinded to the group allocation. Data collected will involve pain at PACU arrival (NRS-0-10), presence of nausea and vomiting, severity of nausea and vomiting, total opioid consumption in PACU, time to discharge using a Modified Postanaesthetic Discharge Scoring System (MPADSS) 9, total opioid consumption 24 hours, QoR40 24hours after surgery.8

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Perioperative Systemic Acetaminophen to Improve Postoperative Quality of Recovery After Ambulatory Breast Surgery
• Study Start Date: November 2013
• Actual Primary Completion Date: December 2014
• Actual Study Completion Date: December 2014

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: IV acetaminophen; Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure.	Drug: IV acetaminophen; Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure
Placebo Comparator: Placebo; Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen	Drug: Placebo; Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen

Outcome Measures

Primary Outcome Measures :

1. Quality of Recovery at 24 Hours(QoR-40 Instrument) [ Time Frame: 24 hours after the surgical procedure ]
   Quality of recovery score 24 hours after the surgical procedure. Total score range of 40 (poor recovery) and a score of 200 (good recovery).

Secondary Outcome Measures :

1. Postoperative Opioid Consumption [ Time Frame: 24 hour ]
   Postoperative opioid consumption over 24 hours. Converted into oral mg of morpine equivalents.
2. Postoperative Pain in the Post Anesthesia Care Unit [ Time Frame: Time in the post anesthesia care unit after surgery (average of 5 hours) ]
   Postoperative pain within the post anesthesia care unit after surgery. Area under the numeric rating scale for pain versus time curve in the post anesthesia care unit (score * min).Numeric rating scale for pain on a scale of 0-10 (0 is no pain and 10 is high pain) versus time curve in the post anesthesia care unit ( score * min). Area under a curve units of the horizontal axis multiplied by the units of the vertical axis. A higher value indicates more pain and time in the Post Anesthesia Care Unit.The range is 0 pain to x time in minutes x 1 hour to 5 hour ( 60-300 minutes) . The pain scores were collected at 15 minute intervals from the time of admission to the PACU. The area under the NRS pain scale versus time curve was calculated using the trapezoidal method as an indicator of pain burden during early recovery (Graph Pad Prism ver 5.03, Graph Pad Software INC.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Outpatient lumpectomy
• ASA I and II
• Age between 18-70

Exclusion:

• Pregnancy
• History of liver disease
• Unable to understand the informed consent
• Chronic pain with use of opioid in the last week
• Allergy to acetaminophen

Drop-out: surgeon or patient request

Contacts and Locations

Locations

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Northwestern University

Investigators

• Principal Investigator: Gildasio De Oliveira, MD; Northwestern University

More Information

Publications:

American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030.

De Oliveira GS Jr, Fitzgerald P, Streicher LF, Marcus RJ, McCarthy RJ. Systemic lidocaine to improve postoperative quality of recovery after ambulatory laparoscopic surgery. Anesth Analg. 2012 Aug;115(2):262-7. doi: 10.1213/ANE.0b013e318257a380. Epub 2012 May 14.

De Oliveira GS Jr, Ahmad S, Fitzgerald PC, Marcus RJ, Altman CS, Panjwani AS, McCarthy RJ. Dose ranging study on the effect of preoperative dexamethasone on postoperative quality of recovery and opioid consumption after ambulatory gynaecological surgery. Br J Anaesth. 2011 Sep;107(3):362-71. doi: 10.1093/bja/aer156. Epub 2011 Jun 13.

De Oliveira GS Jr, Agarwal D, Benzon HT. Perioperative single dose ketorolac to prevent postoperative pain: a meta-analysis of randomized trials. Anesth Analg. 2012 Feb;114(2):424-33. doi: 10.1213/ANE.0b013e3182334d68. Epub 2011 Sep 29. Review.

Cawthorn TR, Phelan R, Davidson JS, Turner KE. Retrospective analysis of perioperative ketorolac and postoperative bleeding in reduction mammoplasty. Can J Anaesth. 2012 May;59(5):466-72. doi: 10.1007/s12630-012-9682-z. Epub 2012 Mar 21.

McNicol ED, Tzortzopoulou A, Cepeda MS, Francia MB, Farhat T, Schumann R. Single-dose intravenous paracetamol or propacetamol for prevention or treatment of postoperative pain: a systematic review and meta-analysis. Br J Anaesth. 2011 Jun;106(6):764-75. doi: 10.1093/bja/aer107. Epub 2011 May 9. Review.

• Responsible Party: Gildasio De Oliveira, Principal Investigator, Northwestern University
• ClinicalTrials.gov Identifier: NCT01852955
• Other Study ID Numbers: STU00078104
• First Posted: May 14, 2013
• Results First Posted: March 14, 2016
• Last Update Posted: March 14, 2016
• Last Verified: February 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Gildasio De Oliveira, Northwestern University:

Outpatient; Surgery; Breast; Pain

Additional relevant MeSH terms:

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