IV Acetaminophen for Postoperative Analgesia

• Sponsor: Northwell Health (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01798316
• Collaborator: (none)
• Enrollment: 105
• Locations: 3
• Arms: 2
• Duration (Months): 30
• Patients Per Site: 35
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the use of IV acetaminophen for postoperative pain management after laparoscopic cholecystectomy to determine if its use to supplement standard of care pain management decreases the incidence of post-operative nausea and vomiting.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain; Postoperative Nausea; Postoperative Vomiting	Drug: IV Acetaminophen; Drug: Standard of Care	Phase 4

Detailed Description

The recent clinical development of an intravenous (IV) acetaminophen formulation for use in the US has important implications for the management of postoperative pain given its safety profile and suitability for use in the early phase of the postoperative period. In clinical studies a significant opioid-sparing effect has been documented with a substantial percentage of patients avoiding the need for opioid rescue medication altogether. This avoidance or delay in the use of opioids has been shown to reduce undesirable side effects. It is proposed that the use of IV acetaminophen in the post anesthesia care unit (PACU) for postoperative analgesia after laparoscopic cholecystectomy will result in decreased incidence of post operative nausea and vomiting (PONV) and decreased use of narcotics.

Study Design

• Study Type: Interventional
• Actual Enrollment: 105 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: IV Acetaminophen for Postoperative Analgesia After Laparoscopic Cholecystectomy
• Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: Sep 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: IV Acetaminophen IV Acetaminophen administered on admission to post-anesthesia care unit	Drug: IV Acetaminophen; Single dose, 1000g mg infusion over 15 minutes plus standard of care pain management regimen; Other Names: Ofirmev
Active Comparator: Standard of care Standard of care pain management regimen including opioids administered on admission to post-anesthesia care unit	Drug: Standard of Care; Standard of care pain management regimen, no IV Acetaminophen,; Other Names: As per provider: Opioids

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Postoperative Nausea and Vomiting (PONV). [4 hours plus/minus 30 minutes]

   Number of participants with postoperative nausea and vomiting (PONV) will be recorded during PACU stay. PONV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching.

Secondary Outcome Measures

1. Number of Participants With Post Discharge Nausea and Vomiting (PDNV) [Up to two days following surgery]

   Number of participants reporting post discharge nausea and vomiting (PDNV) documented up to 2 days following surgery. PDNV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching following discharge.

2. Highest Pain Intensity Score Using Numeric Rating Scale (NRS) [4 hours plus/minus 30 minutes]

   Highest pain intensity reported during PACU stay using a 11-point (0-10) pain intensity numeric rating scale (NRS). Higher values represent higher pain intensities.

3. Patient Satisfaction on a 5 Point Likert Scale [Up to one week following surgery]

   Number of patients very satisfied or satisfied with pain and PONV management during hospital stay

4. Pain Intensity Score 1 Hour Following Surgery Using Numeric Rating Scale [1 hour following surgery]

   Pain intensity score reported by participants 1 hour following surgery using an 11-point, 0-10 Numeric Rating Scale (NRS). Higher scores indicate higher pain intensities

Other Outcome Measures

1. Number of Patients Requiring Rescue Analgesia for Breakthrough Pain [1 hour following surgery]

   Number of patients requiring rescue analgesia medication during first hour of PACU stay

2. Narcotic Use During PACU Stay [4 hours plus/minus 30 minutes]

   Narcotic medication administered during PACU stay in morphine milligram equivalents

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject is undergoing pre-scheduled laparoscopic cholecystectomy;

• American Society of Anesthesiology patient classification status I-II

Exclusion Criteria:

• Regular preoperative use of or opioids,

• Subjects admitted after surgery for postoperative complications other than postoperative pain or PONV.

• Subjects converted to open laparoscopic cholecystectomy

• Known allergy/hypersensitivity to acetaminophen

• Use of opioids prior to commencement of the study (<7 days)

• Patients with chronic pain conditions or disease requiring pain control

• Abnormal liver function

• Known or suspected alcohol, drug or opiate abuse or dependence

• Patients with a BMI of greater than 35

• Other physical, mental or medical conditions that could effect participation.

• Abnormal renal function; serum creatinine>2gm/dl

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	North Shore University Hospital	Manhasset	New York	United States	11030
2	Long Island Jewish Medical Center	New Hyde Park	New York	United States	11040
3	Syosset Hospital	Syosset	New York	United States	11791

Sponsors and Collaborators

• Northwell Health

Investigators

• Principal Investigator: Frank J Overdyk, MD, Northwell Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Northwell Health
• ClinicalTrials.gov Identifier: NCT01798316
• Other Study ID Numbers: 12-0409; IRB #12-409B
• First Posted: Feb 25, 2013
• Last Update Posted: May 31, 2017
• Last Verified: May 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Northwell Health: IV Acetaminophen; Laparoscopic cholecystectomy; Postoperative nausea; Postoperative vomiting
• Additional relevant MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting; Acetaminophen

Study Results

Participant Flow

Arm/Group Title	IV Acetaminophen	Standard of Care
Arm/Group Description	IV Acetaminophen administered before PACU admission IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes	Standard of care pain management regimen including opioids Standard of Care: without IV acetaminophen
Period Title: Overall Study
STARTED	52	53
COMPLETED	52	53
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	IV Acetaminophen	Standard of Care	Total
Arm/Group Description	IV Acetaminophen administered before PACU admission IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes	Standard of care pain management regimen including opioids Standard of Care: No IV acetaminophen	Total of all reporting groups
Overall Participants	52	53	105
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44.6 (13.0)	44.9 (12.3)	44.7 (12.6)
Sex: Female, Male (Count of Participants)
Female	40 76.9%	40 75.5%	80 76.2%
Male	12 23.1%	13 24.5%	25 23.8%
Region of Enrollment (participants) [Number]
United States	52 100%	53 100%	105 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Postoperative Nausea and Vomiting (PONV).
Description	Number of participants with postoperative nausea and vomiting (PONV) will be recorded during PACU stay. PONV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching.
Time Frame	4 hours plus/minus 30 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	IV Acetaminophen	Standard of Care
Arm/Group Description	IV Acetaminophen administered on admission to PACU IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care	Standard of care pain management regimen including opioids administered on admission to PACU No IV Acetaminophen
Measure Participants	52	53
Count of Participants [Participants]	15 28.8%	17 32.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	IV Acetaminophen, Standard of Care
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Chi-squared
	Comments

2. Secondary Outcome

Title	Number of Participants With Post Discharge Nausea and Vomiting (PDNV)
Description	Number of participants reporting post discharge nausea and vomiting (PDNV) documented up to 2 days following surgery. PDNV is defined as nausea intensity of 4 or higher on 0-10 numeric rating scale (NRS) and/or at least one episode of vomiting/retching following discharge.
Time Frame	Up to two days following surgery

Outcome Measure Data

Analysis Population Description

Post-discharge follow up group. Patients not included in analysis were lost to follow up.

Arm/Group Title	IV Acetaminophen	Standard of Care
Arm/Group Description	IV Acetaminophen administered on admission to PACU IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care	Standard of care pain management regimen including opioids administered on admission to PACU No IV acetaminophen
Measure Participants	41	40
Count of Participants [Participants]	4 7.7%	10 18.9%

3. Secondary Outcome

Title	Highest Pain Intensity Score Using Numeric Rating Scale (NRS)
Description	Highest pain intensity reported during PACU stay using a 11-point (0-10) pain intensity numeric rating scale (NRS). Higher values represent higher pain intensities.
Time Frame	4 hours plus/minus 30 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	IV Acetaminophen	Standard of Care
Arm/Group Description	IV Acetaminophen administered before PACU admission IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care	Standard of care pain management regimen including opioids administered on admission to PACU No IV acetaminophen
Measure Participants	52	53
Median (Inter-Quartile Range) [Units on a numerical rating scale]	6	6

4. Secondary Outcome

Title	Patient Satisfaction on a 5 Point Likert Scale
Description	Number of patients very satisfied or satisfied with pain and PONV management during hospital stay
Time Frame	Up to one week following surgery

Outcome Measure Data

Analysis Population Description

Post-discharge follow up group. Patients not included in analysis were lost to follow up.

Arm/Group Title	IV Acetaminophen	Standard of Care
Arm/Group Description	IV Acetaminophen administered on admission to PACU IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care	Standard of care pain management regimen including opioids administered on admission to PACU No IV Acetaminophen
Measure Participants	41	40
Count of Participants [Participants]	38 73.1%	35 66%

5. Secondary Outcome

Title	Pain Intensity Score 1 Hour Following Surgery Using Numeric Rating Scale
Description	Pain intensity score reported by participants 1 hour following surgery using an 11-point, 0-10 Numeric Rating Scale (NRS). Higher scores indicate higher pain intensities
Time Frame	1 hour following surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	IV Acetaminophen	Standard of Care
Arm/Group Description	IV Acetaminophen administered before PACU admission IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care	Standard of care pain management regimen including opioids administered on admission to PACU No IV acetaminophen
Measure Participants	52	53
Median (Inter-Quartile Range) [Units on a numerical rating scale]	3	3

6. Other Pre-specified Outcome

Title	Number of Patients Requiring Rescue Analgesia for Breakthrough Pain
Description	Number of patients requiring rescue analgesia medication during first hour of PACU stay
Time Frame	1 hour following surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	IV Acetaminophen	Standard of Care
Arm/Group Description	IV Acetaminophen administered on admission to PACU IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care	Standard of care pain management regimen including opioids administered on admission to PACU No IV Acetaminophen
Measure Participants	52	53
Count of Participants [Participants]	28 53.8%	20 37.7%

7. Other Pre-specified Outcome

Title	Narcotic Use During PACU Stay
Description	Narcotic medication administered during PACU stay in morphine milligram equivalents
Time Frame	4 hours plus/minus 30 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	IV Acetaminophen	Standard of Care
Arm/Group Description	IV Acetaminophen administered on admission to PACU IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care	Standard of care pain management regimen including opioids administered on admission to PACU No IV Acetaminophen
Measure Participants	52	53
Mean (95% Confidence Interval) [Morphine milligram equivalents]	13.3	16.8

Adverse Events

Arm/Group Title	IV Acetaminophen		Standard of Care
Arm/Group Description	IV Acetaminophen administered on admission to PACU IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care		Standard of care pain management regimen including opioids administered on admission to PACU No IV acetaminophen
All Cause Mortality
	IV Acetaminophen		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	IV Acetaminophen		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/52 (0%)		0/53 (0%)
Other (Not Including Serious) Adverse Events
	IV Acetaminophen		Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	18/52 (34.6%)		23/53 (43.4%)
Gastrointestinal disorders
Nausea	10/52 (19.2%)		15/53 (28.3%)
Vomiting	6/52 (11.5%)		5/53 (9.4%)
Nervous system disorders
Drowziness	0/52 (0%)		2/53 (3.8%)
Headache	1/52 (1.9%)		0/53 (0%)
Dizziness	1/52 (1.9%)		1/53 (1.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.