The Effect of Timing of Intravenous Paracetamol Administration on Post-surgical Pain

July 23, 2017 updated by: Yair Binyamin MD, Soroka University Medical Center

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
126

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥18 years
  • Patients admitted for laparoscopic sleeve gastrectomy
  • Elective surgery
  • BMI > 40
  • American Society of Anesthesiology Classification: 1-2

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: IV paracetamol
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
Drug: IV paracetamol
100 gram paracetamol infusion for moderate pain management
Other Names:
  • Perfalgan infusion (paracetamol)
PLACEBO_COMPARATOR: IV saline (NaCl 0.9 %)
Patients in the second group will receive 100 mL NACL 0.9% (IV NaCl 0.9 %)intraoperative
Drug: IV saline (NaCl 0.9 %)
100 ml of Normal Saline (IV NaCl 0.9 %) as placebo
Other Names:
  • Normal Saline

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
up to 48 hours after surgery
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
up to 48 hours after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total consumption of opiates after surgery
Time Frame: up to 72 hours after surgery
post - operative opioid consumption in manner of dosage and frequency in ward
up to 72 hours after surgery
Respiratory post-operative complication while in ward
Time Frame: up to 72 hours after surgery
Respiratory complication (need of respiratory support, need of intensive care unit hospitalization)
up to 72 hours after surgery
septic post-operative complication while in ward
Time Frame: up to 72 hours after surgery
development of fever above 38° C
up to 72 hours after surgery
Cardiovascular post-operative complication while in ward
Time Frame: up to 72 hours after surgery
Cardiovascular complication (hemodynamic instability, inotropic support )
up to 72 hours after surgery
Gastrointestinal post-operative complication while in ward
Time Frame: up to 72 hours after surgery
Gastrointestinal complaints as nausea and vomiting, need to use antiemetic drug
up to 72 hours after surgery
urinary trak post-operative complication while in ward
Time Frame: up to 72 hours after surgery
Incidence of urinary retention and need for catheterization
up to 72 hours after surgery
post-operative pruritus while in ward
Time Frame: up to 72 hours after surgery
Pruritus
up to 72 hours after surgery
post-operative hospitalization
Time Frame: up to one week after surgery
length of hospital stay by number of days
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
Respiratory complication need of respiratory support, need of intensive care unit hospitalization)
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
Development of fever above 38° C
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
Cardiovascular complication (hemodynamic instability, inotropic support )
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
Gastrointestinal complication as nausea and vomiting, need to use antiemetic drugs
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
incience of urinary retention and need for catheterization
up to 5 hours after surgery
post-operative pruritus while recovering in post anesthesia care unit
Time Frame: up to 5 hours after surgery
Pruritus
up to 5 hours after surgery
post-operative stay in post anesthesia care unit
Time Frame: up to 5 hours after surgery
length of post anesthesia care unit stay by number of hours
up to 5 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Soroka University Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Michael Semionov, MD, Soroka University Medical Center-Department of Anesthesiology
  • Study Chair: Alexander Zlotnic, PhdMD, Soroka University Medical Center-Department of Anesthesiology
  • Principal Investigator: Yair Binyamin, MD, Soroka University Medical Center-Department of Anesthesiology
  • Principal Investigator: Yair Yaish Reina, MD, Soroka University Medical Center-Department of Anesthesiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 25, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • sor17ybyrctil

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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