The Effect of Preemptive Pregabalin on Postoperative Pain and Respiratory Dynamics in Robotic Prostatectomy Operation.

December 6, 2023 updated by: Senay Goksu, Umraniye Education and Research Hospital

The Effect of Preemptive Administration of Pregabalin on Postoperative Pain and Respiratory Dynamics in Patients Undergoing Surgery for Robotic Radical Prostatectomy.

The study aimed to investigate the impact of preemptive pregabalin on the postoperative pain severity and the requirement of analgesic drugs in patients undergoing robotic radical prostatectomy surgery as primary outcome.

Additionally, it examined the effect of pregabalin on early postoperative respiratory dynamics as secondary outcome.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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

Our study will be conducted on a total of 90 patients after ethics committee approval and patient consent. In the prospective observational study, patients will be divided into two groups: those who received preoperative pregabalin and those who did not.

Group 1: those who did not take pregabalin (n:45) Group 2: those who took pregabalin (n:45) Procedure to be applied (interventions) Those who have received pregabalin treatment drink 150 mg of pregabalin with a small amount of water 2 hours before the surgical procedure. All patients receive standard general anesthesia in the operating room after standard hemodynamic monitoring, invasive arterial pressure and Bispectral Index (BIS) monitoring.

Afterwards, all patients receive standard anesthesia maintenance and are monitored in mechanical ventilation (volume-controlled mode), PEEP at 7-8 cmH20 and ETCO2 level at 30-35mmHg during the pneumoperitoneum period. During the pneumoperitoneum period, intra-abdominal pressure is kept within the range of 12-14 mmHg.

During robotic surgery, the standard 45-degree upright Trendelenburg position and perioperative restrictive fluid management are performed. For postoperative analgesia, 0.06 mg/kg morphine, 1 gram (g) paracetomol and 8 mg onasetron are administered iv to all patients 30 minutes before the end of the operation. At the end of surgery and after extubation, patients are taken from the recovery unit to the service in accordance with Aldrete criteria. In the service, all patients are given paracetamol 1g every 8 hours and tenoxicam 20 mg every 24 hours for pain treatment. Tramadol 1 mg/kg iv is administered as rescue analgesic to patients with a VAS score >4.

Recording Data Patients' age, gender, BMI, and comorbidities are recorded. Perioperative heart rate (HR), mean arterial pressure (MAP), peripheral oxygen saturation (SpO2), BIS value, ETCO2, PaCO2 (arterial blood gas), PaO2/Fi02 and peak airway pressure (Ppeak), plateau pressure (Pplato). ) is recorded at the times specified below.

T0: 10th minute after anesthesia induction (supine position 00) T1: 10 minutes after the start of pneumoperitoneum (supine position 00) T2: 30 minutes after the upright Trendelenburg position (450) T3: At the end of pneumoperitoneum (supine position 00) T4: 30 minutes after extubation (recovery unit) The FEV1, FVC, FEV1/FVC values of all patients in the routine respiratory function test performed preoperatively and on the second postoperative day are recorded.

Operation time, Trendelenburg time, perioperative urine amount and general fluid balance are recorded.

Postoperative pain levels of all patients were 30 minutes and 6, 12, 24, 36 days after extubation. It is evaluated and recorded with VAS (Visual Analog Scale) between 0-10 at the 48th and 48th hours.

Analgesic medications administered postoperatively, time of first rescue analgesic (tramadol) administration, total tramadol consumption amount, presence of nausea-vomiting, dizziness, visual impairment, presence of upper airway problems, pulmonary and surgical complications are recorded.

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.
Observational

Enrollment (Estimated)

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.
90

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

Sampling Method

Non-Probability Sample

Study Population

Patients between the ages of 18-75 and with an ASA score of 1-3 who will undergo robotic radical prostatectomy (RARP) surgery under general anesthesia

Description

Inclusion Criteria:

Patients between the ages of 18-75 and with an ASA score of 1-3 who will undergo robotic radical prostatectomy (RARP) surgery under general anesthesia Exclusion criteria Under 18 years of age, over 75 years of age, ASA over 3, history of severe COPD and asthma, history of lobectomy/pneumonectomy, restrictive lung disease, congestive heart failure (NYHA stage 3-4), severe renal and hepatic dysfunction, history of neuromuscular disease, neurological and those with psychiatric problems, extreme obesity or malnutrition (Body mass index >30 or <20), chronic alcohol and opioid use, gabapentinoid, opioid allergy or intolerance, history of chronic pain or fibromyalgia, history of malignant neoplasm, history of gastrointestinal bleeding or perforation, patients in need of intensive care and those who do not consent

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Group 1: those who did not take pregabalin (n:45)
Procedure: robotic surgery under general anaesthesia
During robotic surgery, the standard 45-degree upright Trendelenburg position and for postoperative analgesia, 0.06 mg/kg morphine, 1 gram (g) paracetomol and 8 mg onasetron are administered iv to all patients 30 minutes before the end of the operation. At the end of surgery and after extubation, patients are taken from the recovery unit to the service. In the service, all patients are given paracetamol 1g every 8 hours and tenoxicam 20 mg every 24 hours for pain treatment. Tramadol 1 mg/kg iv is administered as rescue analgesic to patients with a VAS score >4.
Group 2: those who took pregabalin (n:45)
Procedure: robotic surgery under general anaesthesia
During robotic surgery, the standard 45-degree upright Trendelenburg position and for postoperative analgesia, 0.06 mg/kg morphine, 1 gram (g) paracetomol and 8 mg onasetron are administered iv to all patients 30 minutes before the end of the operation. At the end of surgery and after extubation, patients are taken from the recovery unit to the service. In the service, all patients are given paracetamol 1g every 8 hours and tenoxicam 20 mg every 24 hours for pain treatment. Tramadol 1 mg/kg iv is administered as rescue analgesic to patients with a VAS score >4.

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
To investigate the impact of preemptive pregabalin on the postoperative pain
Time Frame: 5 times during surgery and up to 48 hours after surgery
to investigate the impact of preemptive pregabalin on the postoperative pain severity and the requirement of analgesic drugs in patients undergoing robotic radical prostatectomy surgery
5 times during surgery and 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
the effect of pregabalin on early postoperative respiratory dynamics
Time Frame: 5 times during surgery and up to 48 hours after surgery
we will examine the effect of pregabalin on early postoperative respiratory dynamics
5 times during surgery and up to 48 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.
Umraniye Education and Research Hospital

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 (Estimated)

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.
January 1, 2024

Primary Completion (Estimated)

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 28, 2024

Study Completion (Estimated)

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 28, 2024

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).
December 6, 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.
December 6, 2023

First Posted (Estimated)

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.
December 14, 2023

Study Record Updates

Last Update Posted (Estimated)

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.
December 14, 2023

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.
December 6, 2023

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.
December 1, 2023

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.
  • Preemptive Pregabalin

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

product manufactured in and exported from the U.S.

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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