Postoperative Pain, AcuteNCT06170359
The Effect of Preemptive Pregabalin on Postoperative Pain and Respiratory Dynamics in Robotic Prostatectomy Operation.
An observational study of Postoperative Pain, Acute, run by Umraniye Education and Research Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain, Acute
- What is being tested?
- robotic surgery under general anaesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 28 Feb 2024
- How long will I take part?
- 2 Days
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
None listed.
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Pain, Acute
- Being tested
- robotic surgery under general anaesthesia
- Keywords
- preemptive analgesia, pregabalin, pain, robotic surgery
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robotic surgery under general anaesthesiaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: those who did not take pregabalin (n:45) | Not described Receives: Procedure: robotic surgery under general anaesthesia | |
| Group 2: those who took pregabalin (n:45) | Not described Receives: Procedure: robotic surgery under general anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the impact of preemptive pregabalin on the postoperative pain
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
Measured: 5 times during surgery and up to 48 hours after surgery
Secondary outcomes (1)
the effect of pregabalin on early postoperative respiratory dynamics
we will examine the effect of pregabalin on early postoperative respiratory dynamics
Measured: 5 times during surgery and up to 48 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 posted14 Dec 2023
- Study start1 Jan 2024 (estimated)
- Primary completion28 Feb 2024 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain, AcuteStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Senay Goksu, Umraniye Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170359
- Sponsor's protocol ID
- Preemptive Pregabalin
- Status last verified
- Dec 2023
- First submitted
- 6 Dec 2023
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preemptive Administration of Pregabalin on Postoperative Pain and Respiratory Dynamics in Patients Undergoing Surgery for Robotic Radical Prostatectomy.
- ClinicalTrials.gov ID
- NCT06170359
- Acronym / sponsor ID
- Preemptive Pregabalin
- Conditions
- Postoperative Pain, Acute
- Keywords
- preemptive analgesia, pregabalin, pain, robotic surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 14 Dec 2023 (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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: those who did not take pregabalin (n:45) | – | Procedure: robotic surgery under general anaesthesia |
| Group 2: those who took pregabalin (n:45) | – | Procedure: robotic surgery under general anaesthesia |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| robotic surgery under general anaesthesiaDuring 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. | Procedure or surgery | Group 1: those who did not take pregabalin (n:45), Group 2: those who took pregabalin (n:45) |
Primary outcome
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
1 secondary outcome
the effect of pregabalin on early postoperative respiratory dynamics
Time frame: 5 times during surgery and up to 48 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 14 Dec 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, Acute, run by Umraniye Education and Research Hospital.
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 1 inclusion and 0 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 14 Dec 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the impact of preemptive pregabalin on the postoperative pain (time frame: 5 times during surgery and up to 48 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Dec 2023.