Obesity, MorbidEarly Phase 1NCT03221998
The Effect of Timing of Intravenous Paracetamol Administration on Post-surgical Pain
A Early Phase 1 study testing IV paracetamol and IV saline (NaCl 0.9 %) in people with Obesity, Morbid, run by Soroka University Medical Center.
Trial summary
This study is designed as a population-based prospective randomized cohort study. A prospective cohort of patients admitted to laparoscopic sleeve gastrectomy due to morbid obesity Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- IV paracetamol and IV saline (NaCl 0.9 %)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- Jul 2017to Mar 2020
- Phase
- Early Phase 1
- 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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Patients admitted for laparoscopic sleeve gastrectomy
- Elective surgery
- BMI > 40
- American Society of Anesthesiology Classification: 1-2
Who cannot join
- Patients' refusal to participate in the study
- Patients unable to give an informed consent
- Pregnancy
- Emergency surgery
- Patient with known allergy to paracetamol
- Patient with hepatic failure
Show all 13Show fewer
- international normalized ratio >1.7
- Albumin<3.5g/Dl
- Bilirubin >2mg/dL
- Patient with fever > 37.5 ° C
- Patient with hemoglobin < 8
- Patients chronically treated with steroids or steroid-treated patients over a month in the year preceding surgery.
- Drug addict
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Timing of Intravenous Paracetamol Administration on Post-surgical Pain and Cytokines Levels Following Laparoscopic Sleeve Gastrectomy
This study is designed as a population-based prospective randomized cohort study. A prospective cohort of patients admitted to laparoscopic sleeve gastrectomy due to morbid obesity
Read the detailed description
All adult consecutive patients admitted to surgical departments for laparoscopic sleeve gastrectomy will be enrolled prospectively.
For the purposes of the current study we want to determine how much paracetamol (acetaminophen) can reduce the cytokines levels in these patients
The study enrollment period is planned to be a year. The follow-up period for each patient will be until discharge from the hospital.
- Conditions
- Obesity, Morbid
- Being tested
- IV paracetamol, IV saline (NaCl 0.9 %)
- Keywords
- morbidly obese, ,elective sleeve, gastrectomy, paracetamol, IV Perfelgan
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV paracetamolDrug
Also called Perfalgan infusion (paracetamol)
100 gram paracetamol infusion for moderate pain management
IV saline (NaCl 0.9 %)Drug
Also called Normal Saline
100 ml of Normal Saline (IV NaCl 0.9 %) as placebo
| Study group | Role | What they receive |
|---|---|---|
| IV paracetamol | Experimental | Patients in the first group will receive in the operating room before surgery 1 gram (100 ml) of intravenous paracetamol ( IV paracetamol) for 15 minutes intraoperative Receives: Drug: IV paracetamol |
| IV saline (NaCl 0.9 %) | Placebo comparator | Patients in the second group will receive 100 mL NACL 0.9% (IV NaCl 0.9 %)intraoperative Receives: Drug: IV saline (NaCl 0.9 %) |
What is being measured
The primary outcome is the main question the study is designed to answer.
measuring of Visual Analogue pain Scale,
Visual Analogue pain Scale to determine patient level of pain , for establish the correct timing of paracetamol administration
Measured: up to 48 hours after surgery
measuring of Cytokine levels
measuring of Cytokine levels in comparison of timing of paracetamol administration , as a predictor for inflammatory mediators released in response to noxious stimuli
Measured: up to 48 hours after surgery
Secondary outcomes (15)
Total consumption of opiates after surgery
post - operative opioid consumption in manner of dosage and frequency in ward
Measured: up to 72 hours after surgery
Respiratory post-operative complication while in ward
Respiratory complication (need of respiratory support, need of intensive care unit hospitalization)
Measured: up to 72 hours after surgery
septic post-operative complication while in ward
development of fever above 38° C
Measured: up to 72 hours after surgery
Cardiovascular post-operative complication while in ward
Cardiovascular complication (hemodynamic instability, inotropic support )
Measured: up to 72 hours after surgery
Gastrointestinal post-operative complication while in ward
Gastrointestinal complaints as nausea and vomiting, need to use antiemetic drug
Measured: up to 72 hours after surgery
urinary trak post-operative complication while in ward
Incidence of urinary retention and need for catheterization
Measured: up to 72 hours after surgery
post-operative pruritus while in ward
Pruritus
Measured: up to 72 hours after surgery
post-operative hospitalization
length of hospital stay by number of days
Measured: up to one week after surgery
Respiratory post-operative complication while recovering in post anesthesia care unit
Respiratory complication need of respiratory support, need of intensive care unit hospitalization)
Measured: up to 5 hours after surgery
septic post-operative complication while recovering in post anesthesia care unit
Development of fever above 38° C
Measured: up to 5 hours after surgery
Cardiovascular post-operative complication while recovering in post anesthesia care unit
Cardiovascular complication (hemodynamic instability, inotropic support )
Measured: up to 5 hours after surgery
Gastrointestinal post-operative complication while recovering in post anesthesia care unit
Gastrointestinal complication as nausea and vomiting, need to use antiemetic drugs
Measured: up to 5 hours after surgery
urinary retention post-operative complication while recovering in post anesthesia care unit
incience of urinary retention and need for catheterization
Measured: up to 5 hours after surgery
post-operative pruritus while recovering in post anesthesia care unit
Pruritus
Measured: up to 5 hours after surgery
post-operative stay in post anesthesia care unit
length of post anesthesia care unit stay by number of hours
Measured: up to 5 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study startJul 2017 (estimated)
- Primary completionMar 2019 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Obesity, MorbidStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is designed as a population-based prospective randomized cohort study. A prospective cohort of patients admitted to laparoscopic sleeve gastrectomy due to morbid obesity
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yair Binyamin MD, Soroka University Medical Center
- Investigators
- Michael Semionov, MD, Study director, Soroka University Medical Center-Department of AnesthesiologyAlexander Zlotnic, PhdMD, Study chair, Soroka University Medical Center-Department of AnesthesiologyYair Binyamin, MD, Principal investigator, Soroka University Medical Center-Department of AnesthesiologyYair Yaish Reina, MD, Principal investigator, Soroka University Medical Center-Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03221998
- Sponsor's protocol ID
- sor17ybyrctil
- Status last verified
- Jul 2017
- First submitted
- 30 Jun 2017
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ruiz-Tovar J, Munoz JL, Gonzalez J, Zubiaga L, Garcia A, Jimenez M, Ferrigni C, Duran M. Postoperative pain after laparoscopic sleeve gastrectomy: comparison of three analgesic schemes (isolated intravenous analgesia, epidural analgesia associated with intravenous analgesia and port-sites infiltration with bupivacaine associated with intravenous analgesia). Surg Endosc. 2017 Jan;31(1):231-236. doi: 10.1007/s00464-016-4961-3. Epub 2016 May 13.
PubMed 27177956Salihoglu T, Salihoglu Z, Zengin AK, Taskin M, Colakoglu N, Babazade R. The impacts of super obesity versus morbid obesity on respiratory mechanics and simple hemodynamic parameters during bariatric surgery. Obes Surg. 2013 Mar;23(3):379-83. doi: 10.1007/s11695-012-0783-0.
PubMed 23054575Rieg AD, Stoppe C, Rossaint R, Coburn M, Hein M, Schalte G. [EzPAP(R) therapy of postoperative hypoxemia in the recovery room : experiences with the new compact system of end-expiratory positive airway pressure]. Anaesthesist. 2012 Oct;61(10):867-74. doi: 10.1007/s00101-012-2083-4. Epub 2012 Sep 27. German.
PubMed 23011043Cullen A, Ferguson A. Perioperative management of the severely obese patient: a selective pathophysiological review. Can J Anaesth. 2012 Oct;59(10):974-96. doi: 10.1007/s12630-012-9760-2. Epub 2012 Jul 26.
PubMed 22833138Aubrun F, Mazoit JX, Riou B. Postoperative intravenous morphine titration. Br J Anaesth. 2012 Feb;108(2):193-201. doi: 10.1093/bja/aer458.
PubMed 22250276Macintyre PE, Loadsman JA, Scott DA. Opioids, ventilation and acute pain management. Anaesth Intensive Care. 2011 Jul;39(4):545-58. doi: 10.1177/0310057X1103900405.
PubMed 21823370Schug SA, Raymann A. Postoperative pain management of the obese patient. Best Pract Res Clin Anaesthesiol. 2011 Mar;25(1):73-81. doi: 10.1016/j.bpa.2010.12.001.
PubMed 21516915Daszkiewicz A, Wylezol M. Postoperative analgesia in a morbidly obese patient with chronic renal failure. Anestezjol Intens Ter. 2010 Oct-Dec;42(4):197-200.
PubMed 21252836Ahmed S, Morrow E, Morton J. Perioperative considerations when operating on the very obese: tricks of the trade. Minerva Chir. 2010 Dec;65(6):667-75.
PubMed 21224800Pelosi P, Gregoretti C. Perioperative management of obese patients. Best Pract Res Clin Anaesthesiol. 2010 Jun;24(2):211-25. doi: 10.1016/j.bpa.2010.02.001.
PubMed 20608558Hans GA, Lauwick S, Kaba A, Brichant JF, Joris JL. Postoperative respiratory problems in morbidly obese patients. Acta Anaesthesiol Belg. 2009;60(3):169-75.
PubMed 19961114Bodian CA, Freedman G, Hossain S, Eisenkraft JB, Beilin Y. The visual analog scale for pain: clinical significance in postoperative patients. Anesthesiology. 2001 Dec;95(6):1356-61. doi: 10.1097/00000542-200112000-00013.
PubMed 11748392Heinrich S, Horbach T, Salleck D, Birkholz T, Irouschek A, Schmidt J. [Perioperative anaesthesiological management in 167 patients undergoing bariatric surgery]. Zentralbl Chir. 2011 Dec;136(6):604-11. doi: 10.1055/s-0031-1271382. Epub 2011 Apr 14. German.
PubMed 21495003
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Timing of Intravenous Paracetamol Administration on Post-surgical Pain and Cytokines Levels Following Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT03221998
- Acronym / sponsor ID
- sor17ybyrctil
- Conditions
- Obesity, Morbid
- Keywords
- morbidly obese, ,elective sleeve, gastrectomy, paracetamol, IV Perfelgan
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Jul 2017 (estimated)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 19 Jul 2017 (actual)
- 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.
This study is designed as a population-based prospective randomized cohort study. A prospective cohort of patients admitted to laparoscopic sleeve gastrectomy due to morbid obesity
Detailed description
All adult consecutive patients admitted to surgical departments for laparoscopic sleeve gastrectomy will be enrolled prospectively.
For the purposes of the current study we want to determine how much paracetamol (acetaminophen) can reduce the cytokines levels in these patients
The study enrollment period is planned to be a year. The follow-up period for each patient will be until discharge from the hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is designed as a population-based prospective randomized cohort study. A prospective cohort of patients admitted to laparoscopic sleeve gastrectomy due to morbid obesity
| Arm | Type | Receives |
|---|---|---|
| IV paracetamol | Experimental | Drug: IV paracetamolPatients in the first group will receive in the operating room before surgery 1 gram (100 ml) of intravenous paracetamol ( IV paracetamol) for 15 minutes intraoperative |
| IV saline (NaCl 0.9 %) | Placebo comparator | Drug: IV saline (NaCl 0.9 %)Patients in the second group will receive 100 mL NACL 0.9% (IV NaCl 0.9 %)intraoperative |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- Patients admitted for laparoscopic sleeve gastrectomy
- Elective surgery
- BMI > 40
- American Society of Anesthesiology Classification: 1-2
Key exclusion criteria (13 listed)
- Patients' refusal to participate in the study
- Patients unable to give an informed consent
- Pregnancy
- Emergency surgery
- Patient with known allergy to paracetamol
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 paracetamolAlso: Perfalgan infusion (paracetamol)100 gram paracetamol infusion for moderate pain management | Drug | IV paracetamol |
| IV saline (NaCl 0.9 %)Also: Normal Saline100 ml of Normal Saline (IV NaCl 0.9 %) as placebo | Drug | IV saline (NaCl 0.9 %) |
Primary outcome
measuring of Visual Analogue pain Scale,
Time frame: up to 48 hours after surgery
Visual Analogue pain Scale to determine patient level of pain , for establish the correct timing of paracetamol administration
measuring of Cytokine levels
Time frame: up to 48 hours after surgery
measuring of Cytokine levels in comparison of timing of paracetamol administration , as a predictor for inflammatory mediators released in response to noxious stimuli
15 secondary outcomes
Total consumption of opiates after surgery
Time frame: up to 72 hours after surgery
Respiratory post-operative complication while in ward
Time frame: up to 72 hours after surgery
septic post-operative complication while in ward
Time frame: up to 72 hours after surgery
Cardiovascular post-operative complication while in ward
Time frame: up to 72 hours after surgery
Gastrointestinal post-operative complication while in ward
Time frame: up to 72 hours after surgery
urinary trak post-operative complication while in ward
Time frame: up to 72 hours after surgery
post-operative pruritus while in ward
Time frame: up to 72 hours after surgery
post-operative hospitalization
Time frame: up to one week after surgery
Respiratory post-operative complication while recovering in post anesthesia care unit
Time frame: up to 5 hours after surgery
septic post-operative complication while recovering in post anesthesia care unit
Time frame: up to 5 hours after surgery
Cardiovascular post-operative complication while recovering in post anesthesia care unit
Time frame: up to 5 hours after surgery
Gastrointestinal post-operative complication while recovering in post anesthesia care unit
Time frame: up to 5 hours after surgery
urinary retention post-operative complication while recovering in post anesthesia care unit
Time frame: up to 5 hours after surgery
post-operative pruritus while recovering in post anesthesia care unit
Time frame: up to 5 hours after surgery
post-operative stay in post anesthesia care unit
Time frame: up to 5 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
- Background: PubMed 27177956Ruiz-Tovar J, Munoz JL, Gonzalez J, Zubiaga L, Garcia A, Jimenez M, Ferrigni C, Duran M. Postoperative pain after laparoscopic sleeve gastrectomy: comparison of three analgesic schemes (isolated intravenous analgesia, epidural analgesia associated with intravenous analgesia and port-sites infiltration with bupivacaine associated with intravenous analgesia). Surg Endosc. 2017 Jan;31(1):231-236. doi: 10.1007/s00464-016-4961-3. Epub 2016 May 13.
- Results publication: PubMed 23054575Salihoglu T, Salihoglu Z, Zengin AK, Taskin M, Colakoglu N, Babazade R. The impacts of super obesity versus morbid obesity on respiratory mechanics and simple hemodynamic parameters during bariatric surgery. Obes Surg. 2013 Mar;23(3):379-83. doi: 10.1007/s11695-012-0783-0.
- Results publication: PubMed 23011043Rieg AD, Stoppe C, Rossaint R, Coburn M, Hein M, Schalte G. [EzPAP(R) therapy of postoperative hypoxemia in the recovery room : experiences with the new compact system of end-expiratory positive airway pressure]. Anaesthesist. 2012 Oct;61(10):867-74. doi: 10.1007/s00101-012-2083-4. Epub 2012 Sep 27. German.
- Results publication: PubMed 22833138Cullen A, Ferguson A. Perioperative management of the severely obese patient: a selective pathophysiological review. Can J Anaesth. 2012 Oct;59(10):974-96. doi: 10.1007/s12630-012-9760-2. Epub 2012 Jul 26.
- Results publication: PubMed 22250276Aubrun F, Mazoit JX, Riou B. Postoperative intravenous morphine titration. Br J Anaesth. 2012 Feb;108(2):193-201. doi: 10.1093/bja/aer458.
- Results publication: PubMed 21823370Macintyre PE, Loadsman JA, Scott DA. Opioids, ventilation and acute pain management. Anaesth Intensive Care. 2011 Jul;39(4):545-58. doi: 10.1177/0310057X1103900405.
- Results publication: PubMed 21516915Schug SA, Raymann A. Postoperative pain management of the obese patient. Best Pract Res Clin Anaesthesiol. 2011 Mar;25(1):73-81. doi: 10.1016/j.bpa.2010.12.001.
- Results publication: PubMed 21252836Daszkiewicz A, Wylezol M. Postoperative analgesia in a morbidly obese patient with chronic renal failure. Anestezjol Intens Ter. 2010 Oct-Dec;42(4):197-200.
- Results publication: PubMed 21224800Ahmed S, Morrow E, Morton J. Perioperative considerations when operating on the very obese: tricks of the trade. Minerva Chir. 2010 Dec;65(6):667-75.
- Results publication: PubMed 20608558Pelosi P, Gregoretti C. Perioperative management of obese patients. Best Pract Res Clin Anaesthesiol. 2010 Jun;24(2):211-25. doi: 10.1016/j.bpa.2010.02.001.
- Results publication: PubMed 19961114Hans GA, Lauwick S, Kaba A, Brichant JF, Joris JL. Postoperative respiratory problems in morbidly obese patients. Acta Anaesthesiol Belg. 2009;60(3):169-75.
- Results publication: PubMed 11748392Bodian CA, Freedman G, Hossain S, Eisenkraft JB, Beilin Y. The visual analog scale for pain: clinical significance in postoperative patients. Anesthesiology. 2001 Dec;95(6):1356-61. doi: 10.1097/00000542-200112000-00013.
- Individual participant dataSharing planned: Undecided
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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.
Michael Semionov, MD study director
Soroka University Medical Center-Department of Anesthesiology
Alexander Zlotnic, PhdMD study chair
Soroka University Medical Center-Department of Anesthesiology
Yair Binyamin, MD principal investigator
Soroka University Medical Center-Department of Anesthesiology
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing IV paracetamol and IV saline (NaCl 0.9 %) in people with Obesity, Morbid, run by Soroka University Medical Center.
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 5 inclusion and 13 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 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yair Binyamin, MD (+972586963871, Yairben1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measuring of Visual Analogue pain Scale, (time frame: up to 48 hours after surgery). The study lists 2 primary outcomes in all. 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 NCT03221998, which also lists 13 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 25 Jul 2017.