Morbid ObesityIV APAPNCT01460667
Efficacy of IV Acetaminophen in Acute Post-Operative Pain Control in Laparoscopic Roux-en-Y Gastric Bypass Surgery (LRYGBP) Patients
A study testing IV acetaminophen and IV normal saline in people with Morbid Obesity, run by McLaren Regional Medical Center at 1 site in United States.
Trial summary
Laparoscopic Roux-en-Y gastric bypass (LRYGBP) is a common type of surgery in which length of stay and morbidity is intimately associated with post-operative nausea and vomiting (PONV) and recovery of bowel function. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- IV acetaminophen and IV normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who are scheduled to undergo laparoscopic Roux-en-Y gastric bypass surgery (LRYGBP) under general anesthesia.
- age 18 to 65 years
- BMI >35
- ASA scores 1,2, or 3
- a negative pregnancy test for female subjects of childbearing age
- ability to read, understand and provide informed consent to the study procedures
- ability to read and understand the use of pain and nausea scales (VAS)
Who cannot join
- known hypersensitivity to acetaminophen or opioids
- use of opioid or schedule II medications prior to commencement of the study >7 days
- those with chronic pain conditions or significant medical disease requiring pain control
- abnormal liver function (aspartate aminotransferase/alanine aminotransferase/bilirubin > 3X upper limit of normal range, active hepatic disease, clinically significant liver disease, cirrhosis or hepatitis)
- known or suspected alcohol, drug or opiate abuse or dependence; or participation in other clinical study within 30 days of surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
McLaren Regional Medical Center
Flint, Michigan, 48532
Christina Lee, B.Sc., 517-505-4640, leechr28@msu.edu
Christina Lee, B.Sc.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Center Study of IV Acetaminophen for the Treatment of Post-Operative Pain After Laparoscopic Roux-en-Y Gastric Bypass Surgery (LRYGBP)
Laparoscopic Roux-en-Y gastric bypass (LRYGBP) is a common type of surgery in which length of stay and morbidity is intimately associated with post-operative nausea and vomiting (PONV) and recovery of bowel function. Medications most commonly used to control for post-operative pain are opioid medications, whose well known adverse effects include PONV. Currently, no studied adequate alternative to opiates exists for mild-moderate pain relief without the aforementioned risks.
The primary goal for this study is to evaluate the the administration of pre- and post-operative IV acetaminophen to determine if there is in an overall decrease in the use of opioid analgesics by patient controlled analgesia (PCA) and subsequent decrease in subjective PONV leading to sooner return of bowel function, enabling progression to oral intake and decrease in post-operative length of stay.
Read the detailed description
Opioid use during the post-operative period is a highly effective means of treatment for acute pain, however not without its adverse effects including post-operative nausea, vomiting (PONV), constipation, urinary retention, sedation and respiratory depression. Such factors have been implied in the literature to contribute to prolonged post-operative length of stay, delayed return to diet, return of bowel function and increased incidence of ileus. Alternatively, non-opioids, such as acetaminophen, aspirin, NSAIDs, and selective cyclo-oxygenase-2 inhibitors, can be utilized for acute pain, either alone or in combination with opioids. In the bariatric post-surgical population, NSAIDS both oral and IV (Toradol, Ibuprofen) are not recommended due to their potential bleeding tendency, anti-inflammatory effect, and ulcerogenic effect.
The LRYGBP may be classified as a surgery type associated with mild to moderate post-operative pain. Therefore, the mode of pain relief could directly affect the length of stay. The advent of IV acetaminophen serves as a opportunity to investigate in detail the efficacy of this non-opioid medication in the management of acute pain in the immediate post-operative period without the aforementioned adverse effects as expected from traditional opiate medications. A comprehensive approach to this study includes a prospective, double-blinded, randomized controlled trial of subjects who will undergo LRYGBP and randomized to the study agent (IV acetaminophen) or placebo.
- Conditions
- Morbid Obesity
- Being tested
- IV acetaminophen, IV normal saline
- Keywords
- Laparoscopic Roux-en-Y Gastric Bypass, Post-Operative Pain, IV Acetaminophen, Post-Operative Nausea and Vomiting
- Medical subject headings
- Obesity, Morbid, Pain, Postoperative, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV acetaminophenDrug
IV acetaminophen 1000 mg (100 mL) every 6 hours over 30 hours
IV normal salineDrug
0.9% normal saline IV, every 6 hours over 30 hours.
| Study group | Role | What they receive |
|---|---|---|
| IV acetaminophen | Active comparator | Not described Receives: Drug: IV acetaminophen |
| IV 0.9% normal saline | Placebo comparator | Not described Receives: Drug: IV normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in post-operative opiate consumption (PCA)
Measured: hourly, 30 hours from first dose of study agent
Secondary outcomes (7)
post-operative subjective pain intensity
Measured: every 2 hours, 30 hours from first dose of study agent
post-operative nausea and vomiting (PONV)
Measured: every 2 hours, 30 hours from first dose of study agent
time to first post-operative drug administration
Measured: up to 30 hours from first dose of study agent
time to return to flatus
Measured: up to 30 hours from first dose of study agent
acceptance of rescue medication
Measured: up to 30 hours from first dose of study agent
time to first request for rescue medication
Measured: up to 30 hours from first dose of study agent
readiness for discharge
Measured: up to 72 hours from the first dose of study agent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McLaren Regional Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cadence Pharmaceuticals
- Responsible party
- Principal investigator, Christina Lee, McLaren Regional Medical Center
- Investigators
- Christina Lee, B.Sc., Study director, McLaren Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01460667
- Sponsor's protocol ID
- IV APAP LRYGBP Study
- Acronym
- IV APAP
- Status last verified
- Oct 2011
- First submitted
- 19 Oct 2011
- Last updated
- 27 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nguyen NT, Ho HS, Palmer LS, Wolfe BM. A comparison study of laparoscopic versus open gastric bypass for morbid obesity. J Am Coll Surg. 2000 Aug;191(2):149-55; discussion 155-7. doi: 10.1016/s1072-7515(00)00276-3.
PubMed 10945358Walder B, Schafer M, Henzi I, Tramer MR. Efficacy and safety of patient-controlled opioid analgesia for acute postoperative pain. A quantitative systematic review. Acta Anaesthesiol Scand. 2001 Aug;45(7):795-804. doi: 10.1034/j.1399-6576.2001.045007795.x.
PubMed 11472277Macario A, Royal MA. A literature review of randomized clinical trials of intravenous acetaminophen (paracetamol) for acute postoperative pain. Pain Pract. 2011 May-Jun;11(3):290-6. doi: 10.1111/j.1533-2500.2010.00426.x. Epub 2010 Nov 28.
PubMed 21114616Wininger SJ, Miller H, Minkowitz HS, Royal MA, Ang RY, Breitmeyer JB, Singla NK. A randomized, double-blind, placebo-controlled, multicenter, repeat-dose study of two intravenous acetaminophen dosing regimens for the treatment of pain after abdominal laparoscopic surgery. Clin Ther. 2010 Dec;32(14):2348-69. doi: 10.1016/j.clinthera.2010.12.011.
PubMed 21353105Madan AK, Ternovits CA, Speck KE, Tichansky DS. Inpatient pain medication requirements after laparoscopic gastric bypass. Obes Surg. 2005 Jun-Jul;15(6):778-81. doi: 10.1381/0960892054222812.
PubMed 15978146
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single Center Study of IV Acetaminophen for the Treatment of Post-Operative Pain After Laparoscopic Roux-en-Y Gastric Bypass Surgery (LRYGBP)
- ClinicalTrials.gov ID
- NCT01460667
- Acronym / sponsor ID
- IV APAP / IV APAP LRYGBP Study
- Conditions
- Morbid Obesity
- Keywords
- Laparoscopic Roux-en-Y Gastric Bypass, Post-Operative Pain, IV Acetaminophen, Post-Operative Nausea and Vomiting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- McLaren Regional Medical CenterUniversity, hospital or other
- Collaborators
- Cadence Pharmaceuticals
- Study start
- Oct 2011
- Primary completion
- Oct 2012 (estimated)
- First posted
- 27 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Laparoscopic Roux-en-Y gastric bypass (LRYGBP) is a common type of surgery in which length of stay and morbidity is intimately associated with post-operative nausea and vomiting (PONV) and recovery of bowel function. Medications most commonly used to control for post-operative pain are opioid medications, whose well known adverse effects include PONV. Currently, no studied adequate alternative to opiates exists for mild-moderate pain relief without the aforementioned risks.
The primary goal for this study is to evaluate the the administration of pre- and post-operative IV acetaminophen to determine if there is in an overall decrease in the use of opioid analgesics by patient controlled analgesia (PCA) and subsequent decrease in subjective PONV leading to sooner return of bowel function, enabling progression to oral intake and decrease in post-operative length of stay.
Detailed description
Opioid use during the post-operative period is a highly effective means of treatment for acute pain, however not without its adverse effects including post-operative nausea, vomiting (PONV), constipation, urinary retention, sedation and respiratory depression. Such factors have been implied in the literature to contribute to prolonged post-operative length of stay, delayed return to diet, return of bowel function and increased incidence of ileus. Alternatively, non-opioids, such as acetaminophen, aspirin, NSAIDs, and selective cyclo-oxygenase-2 inhibitors, can be utilized for acute pain, either alone or in combination with opioids. In the bariatric post-surgical population, NSAIDS both oral and IV (Toradol, Ibuprofen) are not recommended due to their potential bleeding tendency, anti-inflammatory effect, and ulcerogenic effect.
The LRYGBP may be classified as a surgery type associated with mild to moderate post-operative pain. Therefore, the mode of pain relief could directly affect the length of stay. The advent of IV acetaminophen serves as a opportunity to investigate in detail the efficacy of this non-opioid medication in the management of acute pain in the immediate post-operative period without the aforementioned adverse effects as expected from traditional opiate medications. A comprehensive approach to this study includes a prospective, double-blinded, randomized controlled trial of subjects who will undergo LRYGBP and randomized to the study agent (IV acetaminophen) or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV acetaminophen | Active comparator | Drug: IV acetaminophen |
| IV 0.9% normal saline | Placebo comparator | Drug: IV normal saline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- patients who are scheduled to undergo laparoscopic Roux-en-Y gastric bypass surgery (LRYGBP) under general anesthesia.
- age 18 to 65 years
- BMI >35
- ASA scores 1,2, or 3
- a negative pregnancy test for female subjects of childbearing age
Key exclusion criteria (5 listed)
- known hypersensitivity to acetaminophen or opioids
- use of opioid or schedule II medications prior to commencement of the study >7 days
- those with chronic pain conditions or significant medical disease requiring pain control
- abnormal liver function (aspartate aminotransferase/alanine aminotransferase/bilirubin > 3X upper limit of normal range, active hepatic disease, clinically significant liver disease, cirrhosis or hepatitis)
- known or suspected alcohol, drug or opiate abuse or dependence; or participation in other clinical study within 30 days of surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV acetaminophenIV acetaminophen 1000 mg (100 mL) every 6 hours over 30 hours | Drug | IV acetaminophen |
| IV normal saline0.9% normal saline IV, every 6 hours over 30 hours. | Drug | IV 0.9% normal saline |
Primary outcome
difference in post-operative opiate consumption (PCA)
Time frame: hourly, 30 hours from first dose of study agent
7 secondary outcomes
post-operative subjective pain intensity
Time frame: every 2 hours, 30 hours from first dose of study agent
post-operative nausea and vomiting (PONV)
Time frame: every 2 hours, 30 hours from first dose of study agent
time to first post-operative drug administration
Time frame: up to 30 hours from first dose of study agent
time to return to flatus
Time frame: up to 30 hours from first dose of study agent
acceptance of rescue medication
Time frame: up to 30 hours from first dose of study agent
time to first request for rescue medication
Time frame: up to 30 hours from first dose of study agent
readiness for discharge
Time frame: up to 72 hours from the first dose of study agent
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2011.
- Background: PubMed 10945358Nguyen NT, Ho HS, Palmer LS, Wolfe BM. A comparison study of laparoscopic versus open gastric bypass for morbid obesity. J Am Coll Surg. 2000 Aug;191(2):149-55; discussion 155-7. doi: 10.1016/s1072-7515(00)00276-3.
- Results publication: PubMed 11472277Walder B, Schafer M, Henzi I, Tramer MR. Efficacy and safety of patient-controlled opioid analgesia for acute postoperative pain. A quantitative systematic review. Acta Anaesthesiol Scand. 2001 Aug;45(7):795-804. doi: 10.1034/j.1399-6576.2001.045007795.x.
- Results publication: PubMed 21114616Macario A, Royal MA. A literature review of randomized clinical trials of intravenous acetaminophen (paracetamol) for acute postoperative pain. Pain Pract. 2011 May-Jun;11(3):290-6. doi: 10.1111/j.1533-2500.2010.00426.x. Epub 2010 Nov 28.
- Results publication: PubMed 21353105Wininger SJ, Miller H, Minkowitz HS, Royal MA, Ang RY, Breitmeyer JB, Singla NK. A randomized, double-blind, placebo-controlled, multicenter, repeat-dose study of two intravenous acetaminophen dosing regimens for the treatment of pain after abdominal laparoscopic surgery. Clin Ther. 2010 Dec;32(14):2348-69. doi: 10.1016/j.clinthera.2010.12.011.
- Results publication: PubMed 15978146Madan AK, Ternovits CA, Speck KE, Tichansky DS. Inpatient pain medication requirements after laparoscopic gastric bypass. Obes Surg. 2005 Jun-Jul;15(6):778-81. doi: 10.1381/0960892054222812.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Lee, B.Sc. study director
McLaren Regional Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IV acetaminophen and IV normal saline in people with Morbid Obesity, run by McLaren Regional Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christina Lee, B.Sc. (517-505-4640, leechr28@msu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in post-operative opiate consumption (PCA) (time frame: hourly, 30 hours from first dose of study agent). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01460667, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2011.