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

NCT06170359 | Unknown

• 1 other identifier: Preemptive Pregabalin
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

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

Conditions

Postoperative Pain, Acute

Keywords

preemptive analgesia, pregabalin, pain, robotic surgery

Outcome Measures

Primary Outcomes (1)

• 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

  5 times during surgery and up to 48 hours after surgery

Secondary Outcomes (1)

• the effect of pregabalin on early postoperative respiratory dynamics

  5 times during surgery and up to 48 hours after surgery

Study Arms (2)

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

Interventions

robotic surgery under general anaesthesia PROCEDURE

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 1: those who did not take pregabalin (n:45); Group 2: those who took pregabalin (n:45)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

Sponsors & Collaborators

• Umraniye Education and Research Hospital: lead

MeSH Terms

Conditions

Pain, Postoperative; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Days
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: SPECIALIST, MD,

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 14, 2023
• Study Start: January 1, 2024
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: December 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share