Erector Spinae Plane Block for Postoperative Pain in Percutaneous Nephrolithotomy Patients: a Retrospective Study

NCT03897933 | Completed

• 1 other identifier: 2019/881
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Percutaneous Nephrolithotomy

Keywords

Erector spinae block; percutaneous; nephrolithotomy; stone; ultrasound

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Demographic data

  24 hours after surgery

• incidences of adverse effects (like nausea and vomiting)

  24 hours after surgery

Study Arms (2)

Erector spinae plane block group (ESP)

Single- shot ultrasound guided ESP block with 30 ml 0.25% bupivacain at the T10 vertebral level was performed preoperatively to patients in the ESP group (Group I).

Procedure: Erector Spinae Plane block ( Group I)

non- blocked Group

consists of the patient group without any procedure

Procedure: non- blocked Group (GROUP II)

Interventions

Erector Spinae Plane block ( Group I) PROCEDURE

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.

Erector spinae plane block group (ESP)

non- blocked Group (GROUP II) PROCEDURE

This group was received no intervetion. Patients in all groups were provided with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.

non- blocked Group

Eligibility Criteria

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

Study Population

A number of 60 patients undergoing PCNL between January 2019 and December 2019 were included in our study. Patients included in the study were those who were operated from the stone diseases.

You may qualify if:

• ASA I- ASA II Patients

You may not qualify if:

• history of allergy to the study medication
• refusal to participate

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Sibel Seçkin Pehlivan

Kayseri, Talas, 38039, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 30032149 RESULT

• 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 study. J Clin Anesth. 2013 Sep;25(6):459-65. doi: 10.1016/j.jclinane.2013.04.009. Epub 2013 Aug 17.

  PMID: 23965191 RESULT

• Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic 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.2018.06.033. Epub 2018 Jul 2.

  PMID: 29980005 RESULT

MeSH Terms

Conditions

Calculi

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Sibel Pehlivan

  TC Erciyes University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 1, 2019
• Study Start: January 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: February 1, 2020
• Last Updated: August 1, 2022

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available within 24 months of study completion
• Access Criteria: Data accept requests will be reviewed by an external independent Review Panel.Requesters will be required to sign a Data Access Agreement

Locations

TU (1)