Preemptive Oral Gabapentin 600 mg in Reducing Morphine Requirement After Non Obstetric Lower Abdominal Surgery

September 5, 2021 updated by: Andi Ade Wijaya Ramlan, Indonesia University

Effectiveness of Preemptive Oral Gabapentin 600 mg on Morphine Requirement After Non Obstetric Lower Abdominal Surgery

This study aimed to get the information about the effectiveness of preemptive oral gabapentin 600 mg in reducing morphine requirement after non obstetric lower abdominal surgery

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

Seventy-two subjects were given informed consent before enrolling the study and randomized into two groups; gabapentin and placebo. Two hours before the incision, patients were given preemptive analgesia, either gabapentin or placebo. Non-invasive blood pressure monitor, electrocardiogram (ECG), and pulse oxymetry were set on the subjects in the operating room. General anesthesia induction was done by fentanyl 2 mcg/kg and propofol 2 mg/kg. Endotracheal tube (ETT) intubation was facilitated with atracurium 0.5 mg/kg as muscle relaxant. Maintenance was done by sevoflurane, oxygen, and compressed air. After surgery, patients were extubated until fully conscious. Patients will be transported to recovery room postoperatively. Besides paracetamol as the postoperative analgesia, we also attached patient controlled analgesia (PCA) system to patients' intravenous line using continuous ambulatory delivery device (CADD) contained morphine 1 mg/ml with settings 1 mg per requirement, interval limit within 5 minutes, maximum dose 6 mg/hour intravenously. Cumulative morphine requirement, mean visual analogue scale, and time interval after surgery to the first administration of morphine will be assessed in this study.

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.
72

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 2
  • 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 Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta, DKI Jakarta, Indonesia, 10430
        • Cipto Mangunkusumo Cental National Hospital

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Male or female
  • Age: 18-65 years old
  • Weigh in range around 20% of the ideal body weight
  • Physical status ASA I-II
  • Scheduled for elective non-obstetric lower abdominal surgery with general anesthesia
  • Duration of surgery less than 4 hours
  • Patients who agreed to participate in this study and sign informed consent

Exclusion criteria:

  • Patients who have history of allergy or hypersensitivity to gabapentin, paracetamol, morphine, or the other opioids
  • Patients who consumed analgesia and NSAID less than 12 hours before surgery
  • Patients who experienced physical trauma less than 4 days before surgery
  • Patients who have contraindications to gabapentin, morphine, and paracetamol
  • Patients who were treated with neuraxial block or peripheral nerve block before and during surgery
  • Patients who have history of diabetes, severe live or renal disease
  • Patients who were treated with antihypertension, sedatives, hypnotics, antidepressants, and the other drugs that have effects on nervous system
  • Patients who have psychiatric disorders
  • Patients who consumed gabapentin before perioperative period
  • Pregnant or breastfeeding patients

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: Single

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.
Placebo Comparator: Placebo
Patient will receive oral placebo
Other: Placebo
Oral NaCl 500 mg
Active Comparator: Gabapentin
Patient will receive preemptive oral gabapentin 600 mg
Drug: Gabapentin
Oral Gabapentin 600 mg

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
Cumulative morphine requirement within 24 hours after non obstetric lower abdominal surgery
Time Frame: 24 hours after surgery
Measured by total consumption of morphine on patient controlled analgesia machine
24 hours after surgery
Pain within 24 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale
Time Frame: 24 hours after surgery

Measured by visual analogue scale The visual analogue scale is a measurement to assess the severity of pain. In this context, the patients will be assessed by letting them point the score on a device based on their pain experiences.

The minimum value is 0 and the maximum is 10. The higher the score, the more severe the pain is.
24 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
Pain within 2 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale
Time Frame: 2 hours after surgery

Measured by visual analogue scale The visual analogue scale is a measurement to assess the severity of pain. In this context, the patients will be assessed by letting them point the score on a device based on their pain experiences.

The minimum value is 0 and the maximum is 10. The higher the score, the more severe the pain is.
2 hours after surgery
Pain within 6 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale
Time Frame: 6 hours after surgery

Measured by visual analogue scale The visual analogue scale is a measurement to assess the severity of pain. In this context, the patients will be assessed by letting them point the score on a device based on their pain experiences.

The minimum value is 0 and the maximum is 10. The higher the score, the more severe the pain is.
6 hours after surgery
Pain within 12 hours after non obstetric lower abdominal surgerysurgery: visual analogue scale
Time Frame: 12 hours after surgery

Measured by visual analogue scale The visual analogue scale is a measurement to assess the severity of pain. In this context, the patients will be assessed by letting them point the score on a device based on their pain experiences.

The minimum value is 0 and the maximum is 10. The higher the score, the more severe the pain is.
12 hours after surgery
Cumulative morphine requirement within 2 hours after non obstetric lower abdominal surgery
Time Frame: 2 hours after surgery
Measured by total consumption of morphine on patient controlled analgesia machine
2 hours after surgery
Cumulative morphine requirement within 6 hours after non obstetric lower abdominal surgery
Time Frame: 6 hours after surgery
Measured by total consumption of morphine on patient controlled analgesia machine
6 hours after surgery
Cumulative morphine requirement within 12 hours after non obstetric lower abdominal surgery
Time Frame: 12 hours after surgery
Measured by total consumption of morphine on patient controlled analgesia machine
12 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.
Indonesia 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

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.
November 11, 2019

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.
February 29, 2020

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.
February 29, 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).
May 29, 2020

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 15, 2020

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 16, 2020

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.
September 13, 2021

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.
September 5, 2021

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.
September 1, 2021

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.
  • IndonesiaUAnes 054

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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