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Erector Spina Plane Block Volume Comparison - Trial NCT06332313

Access comprehensive clinical trial information for NCT06332313 through Pure Global AI's free database. This phase not specified trial is sponsored by Kahramanmaras Sutcu Imam University and is currently Not yet recruiting. The study focuses on Pain, Postoperative. Target enrollment is 60 participants.

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NCT06332313
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Trial Details
ClinicalTrials.gov โ€ข NCT06332313
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Erector Spina Plane Block Volume Comparison
Comparison of Patient-Controlled Analgesia and Erector Spina Blocks Applied at Different Volumes in Postoperative Pain Management in Retrograde Intrarenal Surgery Operations

Study Focus

Pain, Postoperative

erector spina plane block

Interventional

procedure

Sponsor & Location

Kahramanmaras Sutcu Imam University

Timeline & Enrollment

N/A

Jun 12, 2024

Dec 05, 2024

60 participants

Primary Outcome

The aim is to observe the difference in tramadol consumption within the first 24 hours after surgery in 3 groups.

Summary

After obtaining ethical committee approval from Kahramanmaras University Anesthesiology and
 Reanimation Department and Urology Clinic, 60 patients between 18-65 years old who meet ASA
 I-II classification criteria with body mass index โ‰ค40 will be informed about this study both
 verbally and in writing prior to their inclusion in this study using a randomization method
 according to Helsinki Declaration after obtaining their written consent. Patients who cannot
 give consent due to any reason or have allergy history against local anesthetics or
 contraindications for peripheral nerve blocks (local infection,coagulopathy etc.) or
 psychiatric disorders or receiving antipsychotic drugs will be excluded from this study.
 Routine preoperative evaluation including age, height, and weight measurements will be
 performed on all patients at pre-anesthesia clinic.
 
 Patients will be randomized into three groups: Group K, who will receive analgesia with
 patient-controlled analgesia (PCA) with tramadol only; Group E20, who will receive PCA with
 20cc volume of ESP block; and Group E30, who will receive PCA with 30cc volume of ESP block.
 After standard general anesthesia induction and endotracheal intubation, one of the three
 analgesic methods will be randomly applied, and the surgery will commence. All patients will
 receive patient-controlled analgesia. Patients in Group K will not receive any local
 anesthetic injection. When the patient is transferred to the postoperative care unit,
 intravenous PCA device will be attached, and pain scores using Visual Analog Scale (VAS),
 rated from 0 (no pain) to 10 (worst pain ever experienced), at rest and during coughing will
 be evaluated at 2, 4, 6, 12, 18, and 24 hours postoperatively. The values will be recorded.
 When the patient experiences pain, analgesic agents will be administered according to the
 patient-controlled analgesia protocol. The time of first analgesic requirement and total
 amount of consumed analgesic agent within 24 hours will be recorded. Postoperative QUIPS:
 Quality Improvement in Postoperative Pain Management questionnaire will be administered, and
 side effects such as nausea/vomiting or sedation will be noted. Additionally, patient
 satisfaction regarding these methods and their willingness for repeat surgery or
 recommendation level on a scale from poor to excellent (very
 poor/poor/fair/good/excellent)will also be evaluated and recorded

ICD-10 Classifications

During surgical operation
During surgical operation
During surgical operation
Pain, unspecified
Postoperative intestinal obstruction

Data Source

ClinicalTrials.gov

NCT06332313

Non-Device Trial