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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03897933
Other study ID # 2019/881
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date February 1, 2020

Study information

Verified date January 2020
Source TC Erciyes University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To evaluate the ability of Erector spina Plane block decrease postoperative pain and analgesia requirements in patients undergoing Percutaneous Nephrolithotomy.


Description:

Erector spina Plane block was performed with guided ultrasound at T10 Transverse process level would lead to adequate postoperative analgesia ,in Percutaneous Nephrolithotomy surgeries.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date February 1, 2020
Est. primary completion date January 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - ASA I- ASA II Patients Exclusion Criteria: - history of allergy to the study medication - refusal to participate

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Erector Spinae Plane block ( Group I)
ESP Block was performed preoperative to all patients in ESP block group. Patients in all groups were provided with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.
non- blocked Group (GROUP II)
This group was received no intervetion. Patients in all groups were provided with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.

Locations

Country Name City State
Turkey Sibel Seçkin Pehlivan Kayseri Talas

Sponsors (1)

Lead Sponsor Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Elkassabany N, Ahmed M, Malkowicz SB, Heitjan DF, Isserman JA, Ochroch EA. Comparison between the analgesic efficacy of transversus abdominis plane (TAP) block and placebo in open retropubic radical prostatectomy: a prospective, randomized, double-blinded — View Citation

Gürkan Y, Aksu C, Kus A, Yörükoglu UH, Kiliç CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018. — View Citation

Liu X, Huang G, Zhong R, Hu S, Deng R. Comparison of Percutaneous Nephrolithotomy Under Regional versus General Anesthesia: A Meta-Analysis of Randomized Controlled Trials. Urol Int. 2018;101(2):132-142. doi: 10.1159/000491021. Epub 2018 Jul 20. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary opioid consumption In the recovery room, all patients were given a patient- controlled analgesia device containing morphine 0.5 mg/ml, set to deliver a 1mg bolus dose of morphine with an 10 min lockout time and 10 mg 4 h limit.Total morphine consumption during the 24 hours postoperative period will recorded at 5 times intervals ( 2, 4, 6, 12, 24 hours). 24 hours after surgery
Primary Verbal analog Pain Scores on rest and movement A Research assistant, blinded to the group allocation, interviewed patients and collected data at 5 times intervals ( 2, 4, 6, 12, 24, hours) in the 24 hours postoperatively. Patients were asked to rate their pain using verbal analog scale, where 0= no pain and 10= worst pain possible. 24 hours after surgery
Secondary Demographic data Age, BMI, ASA, Duration of surgery was recorded. 24 hours after surgery
Secondary incidences of adverse effects (like nausea and vomiting) incidences of nausea and vomiting during the 24 hours postoperative period was recorded recorded at 5 times intervals ( 2, 4, 6, 12, 24 hours). 24 hours after surgery
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