Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05845281
Other study ID # 02.03. 2022/04
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2, 2022
Est. completion date March 20, 2023

Study information

Verified date October 2023
Source Yuzuncu Yil University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary purpose of this study was to compare the effects of erector spinal plane block (ESP) and IV patient-controlled analgesia (PCA) performed to provide analgesia in percutaneous nephrolithotomy surgeries on visual analog skala (VAS), additional analgesia need, patient satisfaction and mobilization times.


Description:

ASA I-III patients aged 18-65 years who underwent percutaneous nephrolithotomy at Van Yüzüncü Yıl University Faculty of Medicine were included in the study. The patients were informed about the study during the preoperative evaluation. In the randomized single-blind closed-envelope study, 30 patients ineach group and a total of 60 patients were included. Standard general anesthesia procedure was applied to all patients. Standard general anesthesia procedure was applied to all patients. Perioperative hemodynamic monitoring was performed. In patients who underwent general anesthesia, after the surgical procedure was completed, after sterility was ensured for the ESP group while the patient was in the lateral position for the ESPB procedure, the linear 10-18 MHz USG probe (Esaote MyLab 30, Geneva, Italy) was placed between two transverse processes in the paramedian plane and increased from 1mg/kg to %1 at the T7 level. 20 ml of 0.5 bupivacaine (Buvasin®, Vem, Istanbul, Turkey) + 2% arrhythmic residual SF from 1mg/kg was administered. For patients in the PCA group, 200 mg of tramadol was placed in 100cc of 0.9% NaCl. Set to PCA device. A 50mg loading dose was administered 10 minutes before the patient was extubated. After extubating, a bolus dose of 20 mg was started, with a 30-minute lock-in time, and an infusion dose of 5mg/hour. The 4-hour maximum limit was set to 200 mg. VAS score, need for additional analgesia, patient satisfaction (Likert scale), mobilization times and vital signs were recorded at 30 minutes, p1, 3, 6 and 12 hours after the operation.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date March 20, 2023
Est. primary completion date February 2, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - American Society of Anesthesiologists (ASA) class I-III, - Between 18-65 years old, - Percutaneous nephrolithotomy surgery, - Patients who agreed to participate in the study Exclusion Criteria: - Obesity (BMI= 35) - Coagulopathy - Active Infection - Drug allergies - Pregnancy - 65 years and older

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Bupivakain + deksametazon Adjuvant
In patients who underwent general anesthesia, after the surgical procedure was completed, after sterility was ensured for the ESP group while the patient was in the lateral position for the ESPB procedure, the linear 10-18 MHz USG probe (Esaote MyLab 30, Geneva, Italy) was placed between two transverse processes in the paramedian plane and increased from 1mg/kg to %1 at the T7 level. 20 ml of 0.5 bupivacaine (Buvasin®, Vem, Istanbul, Turkey) + 2% arrhythmic residual SF from 1mg/kg was administered. For patients in the PCA group, 200 mg of tramadol was placed in 100cc of 0.9% NaCl. Set to PCA device. A 50mg loading dose was administered 10 minutes before the patient was extubated. After extubating, a bolus dose of 20 mg was started, with a 30-minute lock-in time, and an infusion dose of 5mg/hour. The 4-hour maximum limit was set to 200 mg.

Locations

Country Name City State
Turkey Haci Yusuf GUNES VAN

Sponsors (1)

Lead Sponsor Collaborator
Yuzuncu Yil University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Deng W, Hou XM, Zhou XY, Zhou QH. Rhomboid intercostal block combined with sub-serratus plane block versus rhomboid intercostal block for postoperative analgesia after video-assisted thoracoscopic surgery: a prospective randomized-controlled trial. BMC Pulm Med. 2021 Feb 25;21(1):68. doi: 10.1186/s12890-021-01432-7. — View Citation

Liu Y, Zhu W, Zeng G. Percutaneous nephrolithotomy with suction: is this the future? Curr Opin Urol. 2021 Mar 1;31(2):95-101. doi: 10.1097/MOU.0000000000000854. — View Citation

Zeng G, Cai C, Duan X, Xu X, Mao H, Li X, Nie Y, Xie J, Li J, Lu J, Zou X, Mo J, Li C, Li J, Wang W, Yu Y, Fei X, Gu X, Chen J, Kong X, Pang J, Zhu W, Zhao Z, Wu W, Sun H, Liu Y, la Rosette J. Mini Percutaneous Nephrolithotomy Is a Noninferior Modality to Standard Percutaneous Nephrolithotomy for the Management of 20-40mm Renal Calculi: A Multicenter Randomized Controlled Trial. Eur Urol. 2021 Jan;79(1):114-121. doi: 10.1016/j.eururo.2020.09.026. Epub 2020 Sep 29. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Post operative analgesia Visual Analog Scale score were recorded at the post operative 30 minutes, 1st, 3rd, 6th and 12th hours after the operation. High VAS score was interpreted as severe pain in patients. When the VAS score was 4 and above, additional analgesic (15 mg/kg paracetamol) was given intravenously. 24 hours
Primary Additional analgesic drug When the VAS score was 4 and above, 15 mg/kg paracetamol was given intravenously. Additional analgesic drug (Paracetamol) was recorded in milligrams. 24 hours
Primary Patient satisfaction Patient satisfaction was recorded using a Likert scale at the 30th minute, 1st, 3rd, 6th and 12th hours after the operation.
Patient satisfaction was scored between 1 and 5 using a Likert scale at the 30th minute, 1st, 3rd, 6th and 12th hours postoperatively. 1 point not satisfied at all, 2 points dissatisfied, 3 points not sure, 4 points satisfied, 5 points very satisfied.
24 hours
Primary First walking time after surgery Mobilization status was checked and recorded at the 30th minute, 1st, 3rd, 6th and 12th hours after the surgery. We accepted the extubation time as the postoperative 0th hour. We determined the time when the patients started walking for the first time after the surgery accordingly. 24 hours
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05534230 - Dexmedetomidine for Pain Reduction in CABG N/A
Recruiting NCT06275698 - HONEY for the Treatment of POst-Tonsillectomy Pain N/A
Recruiting NCT04436224 - Hydromorphone for ICU-analgesia in Patients With Non-mechanical Ventilation Phase 4
Not yet recruiting NCT04548323 - Hypoalgesic Effects of Walking and Running Imagined
Completed NCT06054945 - Clinical Impact of IPACK Block Addition to Suprainguinal Fascia Iliaca Block
Completed NCT04394481 - Extension of Analgesia by Combined Injection of Dexamethasone and Dexmedetomidine After Arthroscopic Shoulder Surgery Phase 4
Completed NCT04690647 - The Efficacy of Suprainguinal Fascia Iliaca Compartment Block for Analgesia After Elective Total Hip Replacement. N/A
Completed NCT05034601 - ESPB vs TPVB for Postoperative Analgesia After the Nuss Procedure N/A
Completed NCT03740815 - Feasibility of Serratus Plane Block Associated With Sedation in Axillary Dissection N/A
Recruiting NCT05454202 - Assessment of the Interest of ANI in the Non-communicating Patient in Palliative Care
Recruiting NCT04554186 - Serratus Anterior Plane Block Versus Thoracic Paravertebral Block. N/A
Suspended NCT04860635 - Safety of F14 Following Total Knee Replacement Phase 2/Phase 3
Not yet recruiting NCT06393777 - Effectiveness of Pre-administered Natural Sweet-tasting Solution (Honey) for Decreasing Pain of Needle Insertion N/A
Not yet recruiting NCT04519463 - The Effect of Local Anesthesia With Lidocaine During Insertion and Removal of Nasal Packing Early Phase 1
Completed NCT02916342 - Interscalene Block Versus Combined Supraprascapular: Axillary Nerve Blocks Phase 4
Not yet recruiting NCT02549118 - Tenoxicam for Intrapartum Analgesia Phase 2
Completed NCT03206554 - Local Infiltration Analgesia in Total Knee Arthroplasty Phase 2
Not yet recruiting NCT02190760 - Comparison Between Perineural and Systemic Effect of Dexamethasone for Interscalene Brachial Plexus Block. N/A
Completed NCT01789606 - Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet Phase 3
Completed NCT01299584 - ULTIVA Post Marketing Surveillance N/A