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The Efficacy of Erector Spinae Block in Analgesia for Percutaneous Nephrolithotomy Pain

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ClinicalTrials.gov Identifier: NCT03897933
Recruitment Status : Active, not recruiting
First Posted : April 1, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Sibel Seçkin Pehlivan, TC Erciyes University

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

Condition or disease Intervention/treatment Phase
Percutaneous Nephrolithotomy Procedure: Erector Spinae Plane block ( Group I) Procedure: Control Group (GROUP II) Not Applicable

Detailed Description:
Erector spina Plane block will performed with guided ultrasound at T10 Tranverse process level would lead to adequate postoperative analgesia ,in Percutaneous Nephrolithotomy surgeries.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients randomyl allocated to two treatment groups: The ESP block group (Group I) and the control group (Group II). Blocks performed after general anesthesia induction with the USG while patients prone position.
Masking: Double (Participant, Care Provider)
Masking Description: Randomise double bilnd placebo- controlled study
Primary Purpose: Treatment
Official Title: The Efficacy of Erector Spinae Block in Analgesia for Percutaneous Nephrolithotomy Pain
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Erector spinae plane block group (ESP)
Single- shot ultrasound guided ESP block with 15 ml 0.25% bupivacain at the T10 vertebral level will performed preoperatively to patients in the ESP group (Group I).
Procedure: Erector Spinae Plane block ( Group I)
ESP Block will perform preoperative to all patients in ESP block group. Patients in all groups will provide with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.

Placebo Comparator: The Control group
The Control group receive no intervetion ( Group II).
Procedure: Control Group (GROUP II)
Control group will receive no intervetion. Patients in all groups will provide with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.




Primary Outcome Measures :
  1. opioid consumption [ Time Frame: 24 hours after surgery ]
    In the recovery room, all patients will given a patient- controlled analgesia device containing morphine 0.5 mg/ml, set to deliver a 1mg bolus dose of morphine with an 15 min lockout time and 6 mg 1 h limit.Total morphine consumption during the 24 hours postoperative period will recorded at 5 times intervals ( 2, 4, 6, 12, 24 hours).

  2. Verbal analog Pain Scores on rest and movement [ Time Frame: 24 hours after surgery ]
    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.


Secondary Outcome Measures :
  1. Demographic data [ Time Frame: 24 hours after surgery ]
    Age, BMI, ASA, Duration of surgery will recorded.

  2. incidences of adverse effects (like nausea and vomitting) [ Time Frame: 24 hours after surgery ]
    incidences of nausea and vomitting during the 24 hours postoperative period will recorded at 5 times intervals ( 2, 4, 6, 12, 24 hours).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I- ASA II Patients

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897933


Locations
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Turkey
Sibel Seçkin Pehlivan
Kayseri, Talas, Turkey, 38039
Sponsors and Collaborators
TC Erciyes University
Investigators
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Study Director: Sibel Pehlivan TC Erciyes University

Publications of Results:
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Responsible Party: Sibel Seçkin Pehlivan, Teaching Assistant, TC Erciyes University
ClinicalTrials.gov Identifier: NCT03897933     History of Changes
Other Study ID Numbers: 2019/140
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identifed individual participant data for all primary and secondary outcome measures will be made available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available within 24 months of study completion
Access Criteria: Data accep requests will be rewiewed by an external independent Review Panel.Requesters will be required to sign a Data Access Agreement

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sibel Seçkin Pehlivan, TC Erciyes University:
Erector spinae block
percutaneous
nephrolithotomy
stone
ultrasound