Ibuprofen Versus Ketorolac For Postoperative Pain Relief After Cesarean Section

February 27, 2024 updated by: Ahmed Shehab, MD, Alexandria University

The Effectiveness Of Intravenous Ibuprofen Versus Intravenous Ketorolac For Postoperative Pain Relief After Cesarean Section

The aim of this study will be to evaluate the effectiveness of intravenous ibuprofen versus intravenous ketorolac for postoperative pain relief after caesarian section

  1. The Primary outcome is measurement of visual analogue score during rest and movement
  2. The Secondary outcome is measurement of 24 hours opioids requirements.

Study Overview

Status

Status

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

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

METHODS

1. Preoperative assessment:

All parturients included in the study will be assessed thoroughly by:

  1. Proper history taking
  2. Complete clinical examination.
  3. All needed laboratory investigations.

2. Patient preparation:

  • On arrival to the operative theatre , an 18 G intravenous cannula will be inserted in a peripheral vein
  • Steps of general anaesthesia will be explained to the parturients.

Using a multichannel monitor (mindary) iMeC12 SHENZEN MINDRAY BIO-MEDICAL ELECTRONICS CO, LTD, CHINA, the parturients will be continuously monitored for:

  1. Non-invasive arterial blood pressure (NIBP) in (mmHg).
  2. Heart rate (beats/min).
  3. Oxygen saturation (percentage).

  4. End tidal carbon dioxide(mmhg). 3. Anaesthesia technique:

    • Left uterine displacement will be maintained by a wedge under the right hip.
    • Preoxygenation with 100% oxygen will be done for 3-5 minutes
    • For both groups rapid sequence induction will be done with 2mg/kg propofol and 0.9 mg/kg rocuronium,50 microgram fentanyl followed by tracheal intubation and IPPV volume control.
    • Anaesthesia will be maintained with 1.2% isoflurane in 100% Oxygen and 0.1 mg /kg roccuronium will be administrated if needed.
    • After delivery oxytocin infusion 10 IU will be given
    • After finishing operation , inhalational anaesthesia will be stopped and all parturients will receive 2mg/kg sugammadex when train of four is 75%.
    • Then all parturients will be discharged to ward to be put under observation for 24 hours and they will receive NSAID immediately on arrival to the ward .
    • Group A parturients will receive 30 mg ketorolac in 200 cc normal saline intravenously every 6 hours
    • Group B parturients will receive 800 mg Ibuprofen in 200 cc normal saline intravenously every 6 hours
    • All Parturients will receive 25 mg pethidine if visual analogue score (VAS) ≥4.

MEASUREMENTS

The following parameters will be measured for all parturients, in both groups:

  1. Demographic data:

    Age (years) Body Mass index ( kilogram/meters2) Weight (kilograms) Height (meters) Duration of surgery (minutes)

  2. Postoperative hemodynamics:

    • Heart rate (beats/min)

    • Blood pressure (mmHg)

      1. Baseline value immediately after extubation before giving any analgesia.
      2. Immediately and 2, 4, 6, 12, 24 hours after end of surgery.

  3. Visual analogue score:

    • All parturients will be trained to use VAS. VAS at rest (VASR) and during movement (VASM) will be measured at 1,3,6,12,18,24 hours following surgery .The VAS score will be presented as 10 cm horizontal line anchored by the words "no pain"(corresponding to zero) and "worst pain possible"(corresponding to ten).The values will be scored as mild pain(from 1 to 3) ,moderate pain (from 4 to 6) and severe pain (from 7 to 10).
    • If VAS is ≥4 parturients will receive 25mg pethidine iv.
  4. Opioid requirement During the first 24 hours after surgery(mg) The doses of pethidine required during the first 24 hours postoperatively will be calculated.
  5. Nocturnal awakening due to pain (percentage) The percentage of parturients who become awake at night due to pain
  6. Time to ambulate (minutes) The time the parturient takes to get out of bed and to do light activities such as sitting, standing or walking.
  7. Time to first analgesic dose (minutes) rescue analgesia The time when the patient require the first analgesic dose in the ward.

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 (Actual)

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.
50

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.
  • Phase 4

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

Study Locations

  • Egypt
      • Alexandria, Egypt, 21431
        • Ahmed S. Shehab

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Parturients aged 20-30years.
  2. ASA physical satatus: II.
  3. Anticipated hospital stay for at least 24 hours.
  4. Refusal of spinal anaesthesia.

Exclusion Criteria:

  1. Known allergy to the used drugs.
  2. Renal and hepatic impairement
  3. History of brochial asthma.
  4. Low platelets count (<70000).
  5. Bleeding diathesis and with history or risk of intracranial hemorrhage.
  6. Obese and morbidly obese parturients.
  7. GIT problems as gastritis or GI bleeding.

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 Assignment
  • Masking: Quadruple

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.
No Intervention: Group (A):
30mg ketorolac in 200cc normal saline intravenously every 6hours for 24hours postoperatively.
Active Comparator: Group (B):
800mg ibuprofen in 200cc normal saline intravenously every 6 hours for 24hours postoperatively.
Drug: Ibuprofen 800 mg
Intravenous Ibuprofen versus intravenous Ketorolac for postoperative pain relief

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
measurement of visual analogue score
Time Frame: after the surgery average 24 hours postoperative
measurement of visual analogue score during rest and movement . The Score range from 0- 10 . 0 means no pain and 10 indicates the worst pain ever
after the surgery average 24 hours postoperative

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
opioids requirements.
Time Frame: after the surgery average 24 hours postoperative
Total opioid cumulative requirement dose
after the surgery average 24 hours postoperative

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.
Alexandria University

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.
  • Principal Investigator: Ahmed S. Shehab, MD, Alexandria University

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

Helpful Links

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 (Actual)

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.
February 1, 2023

Primary Completion (Actual)

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.
September 30, 2023

Study Completion (Actual)

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.
October 30, 2023

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).
April 18, 2023

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.
June 14, 2023

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.
June 18, 2023

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.
February 28, 2024

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.
February 27, 2024

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.
February 1, 2024

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.
  • 0107307

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

17. there is a plan to make individual participant data (IPD) collected in this study, including data dictionaries, available to other researchers

IPD Sharing Time Frame

to the time when summary data are published

IPD Sharing Access Criteria

Accessible through the web site

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

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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