Abdominal Wall HerniaPhase 4NCT03198871
IV Acetaminophen for Post-Operative Pain Management in Enhanced Recovery After Surgery (ERAS) Population
A Phase 4 study testing Acetaminophen Injectable Product and Sodium Chloride 0.9%, Intravenous in people with Abdominal Wall Hernia and Pancreatic Diseases, run by Kathirvel Subramaniam at 1 site in United States.
Trial summary
Number of patients with unsatisfactory pain relief defined as average visual analog scale (VAS) more than 5 with or without requirement of IVPCA for pain relief during the first 48 hours postoperative period will be compared between the two groups and form the primary outcome for the study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Abdominal Wall Hernia, Pancreatic Diseases, Bowel Disease
- What is being tested?
- Acetaminophen Injectable Product and Sodium Chloride 0.9%, Intravenous
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2018to 30 Nov 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female
- 18 years of age or older
- patients scheduled for elective colorectal, pancreatic, and other major abdominal procedure.
- Patient consent will be obtained preoperatively for eligible study participants.
Who cannot join
- Patients who refuse to participate in the study or part of any other enhanced recovery after surgery (ERAS) research protocol.
- Patients with a documented allergy to acetaminophen.
- Chronic alcoholism
- Hypovolemia
- Chronic malnutrition
- Preoperative renal insufficiency (creatinine clearance less than or equal to 30ml/min) or hemodialysis
Show all 9Show fewer
- Patients with a history of hepatic impairment, history of hepatic impairment or active hepatic disease
- severe chronic pain condition that required daily preoperative opioid dependence
- Patients with pre-existing dementia and/or other neuropsychiatric conditions impeding accurate assessment of pain scores or other study measures will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Upmc Presbyterian Montefiore Hospital
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Role of Scheduled Intravenous Acetaminophen for Postoperative Pain Management in an Enhanced Recovery After Surgery (ERAS) Population: A Prospective, Randomized, Double-Blind and Placebo-Controlled Clinical Trial
Number of patients with unsatisfactory pain relief defined as average visual analog scale (VAS) more than 5 with or without requirement of IVPCA for pain relief during the first 48 hours postoperative period will be compared between the two groups and form the primary outcome for the study. Postoperative pain intensity will be measured by Visual Analog Scale (VAS) with 0- being no pain and 10-being maximum pain and the analgesic efficacy in both groups will also be evaluated by the amount of total narcotic consumption (measured with IV morphine equivalent doses of analgesics used to provide pain relief).
Read the detailed description
In response to an increased focus on improving patient outcomes and satisfaction with surgical care, a growing body of clinical evidence has recently been dedicated to enhanced recovery after surgery (ERAS) protocols. These evidence-based perioperative pathways aim to optimize patients undergoing surgery in the preoperative, intraoperative, and postoperative periods. ERAS protocols have incorporated the use of multimodal analgesia to minimize the use of intra- and postoperative opioid analgesics. Lidocaine, ketamine, magnesium, gabapentin, acetaminophen and non-steroidal anti-inflammatory drugs are some of the adjuvant analgesics used in combination with regional blocks to optimize analgesia and recovery. Multimodal analgesia has dependably been shown to significantly reduce postoperative opioid requirements as well as opioid-related side effects such as postoperative nausea and vomiting. Both oral and intravenous acetaminophen preparations have been shown to be useful adjuvants in multimodal analgesia. Intravenous acetaminophen has been of interest for its utility in post-surgical patients, who have not yet been cleared for oral intake. Intravenous acetaminophen should also be preferred over oral acetaminophen in patients after major abdominal surgery where absorption of medications given through oral route is erratic. Although the efficacy of intravenous acetaminophen as a postoperative pain adjunct is known, its exact role in ERAS protocols and non-narcotic multimodal analgesic regimens for major abdominal surgery has not been studied in randomized clinical trials to define its efficacy. The primary goal of this study is to assess the utility of a postoperative intravenous acetaminophen dosing schedule in minimizing postoperative pain, opioid consumption and opioid-related side effects. We also aim to study overall patient satisfaction and cost-effectiveness (direct and indirect costs) of this regimen as part of ERAS protocol at a large tertiary medical center.
- Being tested
- Acetaminophen Injectable Product, Sodium Chloride 0.9%, Intravenous
- Keywords
- Post-operative pain, Major abdominal surgery, Colorectal surgery, Gastric surgery
- Medical subject headings
- Hernia, Abdominal, Pancreatic Diseases, Intestinal Diseases, Stomach Diseases, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetaminophen Injectable ProductDrug
Also called Tylenol, Paracetamol, Ofirmev
The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively
Sodium Chloride 0.9%, IntravenousDrug
Also called Saline
The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Acetaminophen Injectable Product | Experimental | Acetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group Receives: Drug: Acetaminophen Injectable Product |
| Sodium Chloride 0.9%, Intravenous | Placebo comparator | Sodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group Receives: Drug: Sodium Chloride 0.9%, Intravenous |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity
Number of patients with unsatisfactory pain relief defined as average numeric rating scale (NRS) more than 5 will be compared between the two groups. This may include patients using IVPCA for pain relief during the first 48 hours postoperative.
Measured: PACU admission every thirty minutes until discharge to the floor and thereafter every four hours for first 24-hour, then every six hours until 48 hours and then every twelve hours until 72 hours postoperatively.
Secondary outcomes (12)
Total Post-operative Narcotic Consumption
Rescue analgesia will be given according to institutional pain management protocol. Unit of Measure recorded as OME (Oral Morphine Equivalent) consumption in mg.
Measured: From time of PACU admission until the time of discharge and 72-hours postoperatively, whichever comes first
Time to Readiness for Discharge From Post Anesthesia Care Unit (PACU)
The time from PACU admission to PACU discharge to the floor will be measured.
Measured: From time of PACU admission until the time of discharge, assessed up to 24 hours postoperatively
Time to Bowel Movement
The time it takes for the first bowel movement postoperatively will be measured.
Measured: From time patient left operating room until the time of first documented bowel movement, assessed up to hospital discharge
Time to Oral Intake
The time it takes for the patient to ingest orally post-surgery will be measured.
Measured: From date of randomization until the date of first documented oral intake, assessed up to 72 hours postoperatively
Time to Ambulation
The time it takes for the patient to successfully ambulate post-surgery will be measured.
Measured: From date of PACU admission until the date of first documented ambulation, assessed up to 72 hours postoperatively
Time to Hospital Discharge
The time it takes for the patient to be fully discharged from the hospital post-surgery will be measured.
Measured: From date of randomization until the date of hospital discharge or 30 days postoperatively, whichever comes first
Number of Participants With Readmission to the Hospital
If the patient is readmitted to the hospital after being fully discharged, the event will be recorded.
Measured: From the time of consent until 30 days post-operatively
Patient Satisfaction
Overall patient satisfaction as well as satisfaction relating to pain management and cost analyses will be measured. These will be measured with a numerical rating scale (NRS) with 0- being worst satisfaction and 10 - best satisfaction.
Measured: These measurements will be taken at time of discharge up to 30 days, whichever comes first
Intensive Care Delirium Screening Checklist (ICDSC)
Number of patients who score greater than a 4 on the 0-8 point ICDSC scale to assess delirium scores. 8 separate levels of signs for delirium assessed (1. altered level of consciousness, 2. inattention, 3. disorientation, 4. hallucination, delusion, or psychosis, 5. psychomotor agitation or retardation, 6. inappropriate speech or mood, 7. sleep-wake cycle disturbance, 8. symptom fluctuation), with 0 points awarded when patient does not exhibit above signs of delirium and 1 point awarded per confirmed sign of delirium. Score then totaled, 0 = normal, 1-3 = subsyndromal delirium, 4-8 = delirium.
Measured: The delirium scores will first be measured every 12 hours for 72 hours after surgery.
Post-operative Nausea
Nausea will be evaluated by nausea score from 0 to 10, with 0 equaling no nausea and 10 equaling the worst nausea imaginable.
Measured: These will be evaluated from the time of PACU admission until 72 hours postoperatively.
Post-operative Emesis
Frequency of emesis and rescue antiemetic requirement will be documented
Measured: These will be evaluated from the time of PACU admission until 72 hours postoperatively.
SF-12 Health Survey
Survey to assess patient's overall health (via a combination of mental and physical health assessment) at 30 days post-discharge. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average
Measured: These measurements will take place at 30-days post hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start24 May 2018
- Primary completion7 Jul 2019
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Abdominal Wall HerniaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kathirvel Subramaniam
- Sponsor type
- University, hospital or other
- Collaborators
- Mallinckrodt
- Responsible party
- Sponsor-investigator, Kathirvel Subramaniam, University of Pittsburgh
- Investigators
- Kathirvel Subramaniam, M.D., M.P.H, Principal investigator, Associate Professor and staff Anesthesiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198871
- Sponsor's protocol ID
- PRO17050418
- Status last verified
- Jan 2021
- First submitted
- 19 Jun 2017
- Last updated
- 28 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ziemann-Gimmel P, Hensel P, Koppman J, Marema R. Multimodal analgesia reduces narcotic requirements and antiemetic rescue medication in laparoscopic Roux-en-Y gastric bypass surgery. Surg Obes Relat Dis. 2013 Nov-Dec;9(6):975-80. doi: 10.1016/j.soard.2013.02.003. Epub 2013 Feb 13.
PubMed 23499469Ziemann-Gimmel P, Goldfarb AA, Koppman J, Marema RT. Opioid-free total intravenous anaesthesia reduces postoperative nausea and vomiting in bariatric surgery beyond triple prophylaxis. Br J Anaesth. 2014 May;112(5):906-11. doi: 10.1093/bja/aet551. Epub 2014 Feb 18.
PubMed 24554545Practice guidelines for acute pain management in the perioperative setting. A report by the American Society of Anesthesiologists Task Force on Pain Management, Acute Pain Section. Anesthesiology. 1995 Apr;82(4):1071-81. No abstract available.
PubMed 7717542Hansen RN, Pham A, Strassels SA, Balaban S, Wan GJ. Erratum to: Comparative Analysis of Length of Stay and Inpatient Costs for Orthopedic Surgery Patients Treated with IV Acetaminophen and IV Opioids vs. IV Opioids Alone for Post-Operative Pain. Adv Ther. 2016 Sep;33(9):1646-1648. doi: 10.1007/s12325-016-0400-z. No abstract available.
PubMed 27562836Bollinger AJ, Butler PD, Nies MS, Sietsema DL, Jones CB, Endres TJ. Is Scheduled Intravenous Acetaminophen Effective in the Pain Management Protocol of Geriatric Hip Fractures? Geriatr Orthop Surg Rehabil. 2015 Sep;6(3):202-8. doi: 10.1177/2151458515588560.
PubMed 26328237Herring BO, Ader S, Maldonado A, Hawkins C, Kearson M, Camejo M. Impact of intravenous acetaminophen on reducing opioid use after hysterectomy. Pharmacotherapy. 2014 Dec;34 Suppl 1:27S-33S. doi: 10.1002/phar.1513.
PubMed 25521844Jokela R, Ahonen J, Seitsonen E, Marjakangas P, Korttila K. The influence of ondansetron on the analgesic effect of acetaminophen after laparoscopic hysterectomy. Clin Pharmacol Ther. 2010 Jun;87(6):672-8. doi: 10.1038/clpt.2009.281. Epub 2010 Mar 10.
PubMed 20220746Gonzalez A, Ziemann-Gimmel P. The role of multimodal analgesia in bariatric surgery: A review of clinical data and case-based presentations featuring OFIRMEV® (acetaminophen) injection. Surgical Pain Management. 2014;11(5): A2-11.
Pettersson PH, Jakobsson J, Owall A. Intravenous acetaminophen reduced the use of opioids compared with oral administration after coronary artery bypass grafting. J Cardiothorac Vasc Anesth. 2005 Jun;19(3):306-9. doi: 10.1053/j.jvca.2005.03.006.
PubMed 16130055Mamoun NF, Lin P, Zimmerman NM, Mascha EJ, Mick SL, Insler SR, Sessler DI, Duncan AE. Intravenous acetaminophen analgesia after cardiac surgery: A randomized, blinded, controlled superiority trial. J Thorac Cardiovasc Surg. 2016 Sep;152(3):881-889.e1. doi: 10.1016/j.jtcvs.2016.04.078. Epub 2016 May 5.
PubMed 27236864Douzjian DJ, Kulik A. Old Drug, New Route: A Systematic Review of Intravenous Acetaminophen After Adult Cardiac Surgery. J Cardiothorac Vasc Anesth. 2017 Apr;31(2):694-701. doi: 10.1053/j.jvca.2016.03.134. Epub 2016 Mar 16. No abstract available.
PubMed 27498260Thiele RH, Rea KM, Turrentine FE, Friel CM, Hassinger TE, McMurry TL, Goudreau BJ, Umapathi BA, Kron IL, Sawyer RG, Hedrick TL. Standardization of care: impact of an enhanced recovery protocol on length of stay, complications, and direct costs after colorectal surgery. J Am Coll Surg. 2015 Apr;220(4):430-43. doi: 10.1016/j.jamcollsurg.2014.12.042. Epub 2015 Jan 9.
PubMed 25797725Doleman B, Read D, Lund JN, Williams JP. Preventive Acetaminophen Reduces Postoperative Opioid Consumption, Vomiting, and Pain Scores After Surgery: Systematic Review and Meta-Analysis. Reg Anesth Pain Med. 2015 Nov-Dec;40(6):706-12. doi: 10.1097/AAP.0000000000000311.
PubMed 26469366Remy C, Marret E, Bonnet F. Effects of acetaminophen on morphine side-effects and consumption after major surgery: meta-analysis of randomized controlled trials. Br J Anaesth. 2005 Apr;94(4):505-13. doi: 10.1093/bja/aei085. Epub 2005 Jan 28.
PubMed 15681586Macario 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 21114616
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Scheduled Intravenous Acetaminophen for Postoperative Pain Management in an Enhanced Recovery After Surgery (ERAS) Population: A Prospective, Randomized, Double-Blind and Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03198871
- Acronym / sponsor ID
- PRO17050418
- Keywords
- Post-operative pain, Major abdominal surgery, Colorectal surgery, Gastric surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Kathirvel SubramaniamUniversity, hospital or other
- Collaborators
- Mallinckrodt
- Study start
- 24 May 2018 (actual)
- Primary completion
- 7 Jul 2019 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 26 Jun 2017 (actual)
- Results
- Posted 28 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Number of patients with unsatisfactory pain relief defined as average visual analog scale (VAS) more than 5 with or without requirement of IVPCA for pain relief during the first 48 hours postoperative period will be compared between the two groups and form the primary outcome for the study. Postoperative pain intensity will be measured by Visual Analog Scale (VAS) with 0- being no pain and 10-being maximum pain and the analgesic efficacy in both groups will also be evaluated by the amount of total narcotic consumption (measured with IV morphine equivalent doses of analgesics used to provide pain relief).
Detailed description
In response to an increased focus on improving patient outcomes and satisfaction with surgical care, a growing body of clinical evidence has recently been dedicated to enhanced recovery after surgery (ERAS) protocols. These evidence-based perioperative pathways aim to optimize patients undergoing surgery in the preoperative, intraoperative, and postoperative periods. ERAS protocols have incorporated the use of multimodal analgesia to minimize the use of intra- and postoperative opioid analgesics. Lidocaine, ketamine, magnesium, gabapentin, acetaminophen and non-steroidal anti-inflammatory drugs are some of the adjuvant analgesics used in combination with regional blocks to optimize analgesia and recovery. Multimodal analgesia has dependably been shown to significantly reduce postoperative opioid requirements as well as opioid-related side effects such as postoperative nausea and vomiting. Both oral and intravenous acetaminophen preparations have been shown to be useful adjuvants in multimodal analgesia. Intravenous acetaminophen has been of interest for its utility in post-surgical patients, who have not yet been cleared for oral intake. Intravenous acetaminophen should also be preferred over oral acetaminophen in patients after major abdominal surgery where absorption of medications given through oral route is erratic. Although the efficacy of intravenous acetaminophen as a postoperative pain adjunct is known, its exact role in ERAS protocols and non-narcotic multimodal analgesic regimens for major abdominal surgery has not been studied in randomized clinical trials to define its efficacy. The primary goal of this study is to assess the utility of a postoperative intravenous acetaminophen dosing schedule in minimizing postoperative pain, opioid consumption and opioid-related side effects. We also aim to study overall patient satisfaction and cost-effectiveness (direct and indirect costs) of this regimen as part of ERAS protocol at a large tertiary medical center.
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 |
|---|---|---|
| Acetaminophen Injectable Product | Experimental | Drug: Acetaminophen Injectable ProductAcetaminophen group: Half of subjects enrolled will be randomized to the acetaminophen group |
| Sodium Chloride 0.9%, Intravenous | Placebo comparator | Drug: Sodium Chloride 0.9%, IntravenousSodium Chloride 0.9% group: Half of subjects enrolled will be randomized to the acetaminophen group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or Female
- 18 years of age or older
- patients scheduled for elective colorectal, pancreatic, and other major abdominal procedure.
- Patient consent will be obtained preoperatively for eligible study participants.
Key exclusion criteria (9 listed)
- Patients who refuse to participate in the study or part of any other enhanced recovery after surgery (ERAS) research protocol.
- Patients with a documented allergy to acetaminophen.
- Chronic alcoholism
- Hypovolemia
- Chronic malnutrition
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 |
|---|---|---|
| Acetaminophen Injectable ProductAlso: Tylenol, Paracetamol, OfirmevThe interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively | Drug | Acetaminophen Injectable Product |
| Sodium Chloride 0.9%, IntravenousAlso: SalineThe placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively. | Drug | Sodium Chloride 0.9%, Intravenous |
Primary outcome
Postoperative Pain Intensity
Time frame: PACU admission every thirty minutes until discharge to the floor and thereafter every four hours for first 24-hour, then every six hours until 48 hours and then every twelve hours until 72 hours postoperatively.
Number of patients with unsatisfactory pain relief defined as average numeric rating scale (NRS) more than 5 will be compared between the two groups. This may include patients using IVPCA for pain relief during the first 48 hours postoperative.
12 secondary outcomes
Total Post-operative Narcotic Consumption
Time frame: From time of PACU admission until the time of discharge and 72-hours postoperatively, whichever comes first
Time to Readiness for Discharge From Post Anesthesia Care Unit (PACU)
Time frame: From time of PACU admission until the time of discharge, assessed up to 24 hours postoperatively
Time to Bowel Movement
Time frame: From time patient left operating room until the time of first documented bowel movement, assessed up to hospital discharge
Time to Oral Intake
Time frame: From date of randomization until the date of first documented oral intake, assessed up to 72 hours postoperatively
Time to Ambulation
Time frame: From date of PACU admission until the date of first documented ambulation, assessed up to 72 hours postoperatively
Time to Hospital Discharge
Time frame: From date of randomization until the date of hospital discharge or 30 days postoperatively, whichever comes first
Number of Participants With Readmission to the Hospital
Time frame: From the time of consent until 30 days post-operatively
Patient Satisfaction
Time frame: These measurements will be taken at time of discharge up to 30 days, whichever comes first
Intensive Care Delirium Screening Checklist (ICDSC)
Time frame: The delirium scores will first be measured every 12 hours for 72 hours after surgery.
Post-operative Nausea
Time frame: These will be evaluated from the time of PACU admission until 72 hours postoperatively.
Post-operative Emesis
Time frame: These will be evaluated from the time of PACU admission until 72 hours postoperatively.
SF-12 Health Survey
Time frame: These measurements will take place at 30-days post hospital discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23499469Ziemann-Gimmel P, Hensel P, Koppman J, Marema R. Multimodal analgesia reduces narcotic requirements and antiemetic rescue medication in laparoscopic Roux-en-Y gastric bypass surgery. Surg Obes Relat Dis. 2013 Nov-Dec;9(6):975-80. doi: 10.1016/j.soard.2013.02.003. Epub 2013 Feb 13.
- Background: PubMed 24554545Ziemann-Gimmel P, Goldfarb AA, Koppman J, Marema RT. Opioid-free total intravenous anaesthesia reduces postoperative nausea and vomiting in bariatric surgery beyond triple prophylaxis. Br J Anaesth. 2014 May;112(5):906-11. doi: 10.1093/bja/aet551. Epub 2014 Feb 18.
- Background: PubMed 7717542Practice guidelines for acute pain management in the perioperative setting. A report by the American Society of Anesthesiologists Task Force on Pain Management, Acute Pain Section. Anesthesiology. 1995 Apr;82(4):1071-81. No abstract available.
- Background: PubMed 27562836Hansen RN, Pham A, Strassels SA, Balaban S, Wan GJ. Erratum to: Comparative Analysis of Length of Stay and Inpatient Costs for Orthopedic Surgery Patients Treated with IV Acetaminophen and IV Opioids vs. IV Opioids Alone for Post-Operative Pain. Adv Ther. 2016 Sep;33(9):1646-1648. doi: 10.1007/s12325-016-0400-z. No abstract available.
- Background: PubMed 26328237Bollinger AJ, Butler PD, Nies MS, Sietsema DL, Jones CB, Endres TJ. Is Scheduled Intravenous Acetaminophen Effective in the Pain Management Protocol of Geriatric Hip Fractures? Geriatr Orthop Surg Rehabil. 2015 Sep;6(3):202-8. doi: 10.1177/2151458515588560.
- Background: PubMed 25521844Herring BO, Ader S, Maldonado A, Hawkins C, Kearson M, Camejo M. Impact of intravenous acetaminophen on reducing opioid use after hysterectomy. Pharmacotherapy. 2014 Dec;34 Suppl 1:27S-33S. doi: 10.1002/phar.1513.
- Background: PubMed 20220746Jokela R, Ahonen J, Seitsonen E, Marjakangas P, Korttila K. The influence of ondansetron on the analgesic effect of acetaminophen after laparoscopic hysterectomy. Clin Pharmacol Ther. 2010 Jun;87(6):672-8. doi: 10.1038/clpt.2009.281. Epub 2010 Mar 10.
- BackgroundGonzalez A, Ziemann-Gimmel P. The role of multimodal analgesia in bariatric surgery: A review of clinical data and case-based presentations featuring OFIRMEV® (acetaminophen) injection. Surgical Pain Management. 2014;11(5): A2-11.
- Background: PubMed 16130055Pettersson PH, Jakobsson J, Owall A. Intravenous acetaminophen reduced the use of opioids compared with oral administration after coronary artery bypass grafting. J Cardiothorac Vasc Anesth. 2005 Jun;19(3):306-9. doi: 10.1053/j.jvca.2005.03.006.
- Background: PubMed 27236864Mamoun NF, Lin P, Zimmerman NM, Mascha EJ, Mick SL, Insler SR, Sessler DI, Duncan AE. Intravenous acetaminophen analgesia after cardiac surgery: A randomized, blinded, controlled superiority trial. J Thorac Cardiovasc Surg. 2016 Sep;152(3):881-889.e1. doi: 10.1016/j.jtcvs.2016.04.078. Epub 2016 May 5.
- Background: PubMed 27498260Douzjian DJ, Kulik A. Old Drug, New Route: A Systematic Review of Intravenous Acetaminophen After Adult Cardiac Surgery. J Cardiothorac Vasc Anesth. 2017 Apr;31(2):694-701. doi: 10.1053/j.jvca.2016.03.134. Epub 2016 Mar 16. No abstract available.
- Background: PubMed 25797725Thiele RH, Rea KM, Turrentine FE, Friel CM, Hassinger TE, McMurry TL, Goudreau BJ, Umapathi BA, Kron IL, Sawyer RG, Hedrick TL. Standardization of care: impact of an enhanced recovery protocol on length of stay, complications, and direct costs after colorectal surgery. J Am Coll Surg. 2015 Apr;220(4):430-43. doi: 10.1016/j.jamcollsurg.2014.12.042. Epub 2015 Jan 9.
- Individual participant dataSharing planned: No
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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.
Kathirvel Subramaniam, M.D., M.P.H principal investigator
Associate Professor and staff Anesthesiologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetaminophen Injectable Product and Sodium Chloride 0.9%, Intravenous in people with Abdominal Wall Hernia and Pancreatic Diseases, run by Kathirvel Subramaniam 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 28 Jan 2021. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity (time frame: PACU admission every thirty minutes until discharge to the floor and thereafter every four hours for first 24-hour, then every six hours until 48 hours and then every twelve hours until 72 hours postoperatively.). 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 NCT03198871, which also lists 32 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 28 Jan 2021.