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
|Condition or disease||Intervention/treatment||Phase|
|Percutaneous Nephrolithotomy||Procedure: Erector Spinae Plane block ( Group I) Procedure: Control Group (GROUP II)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|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|
|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|
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.
- 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).
- 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.
- Demographic data [ Time Frame: 24 hours after surgery ]Age, BMI, ASA, Duration of surgery will recorded.
- 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).
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
|Sibel Seçkin Pehlivan|
|Kayseri, Talas, Turkey, 38039|
|Study Director:||Sibel Pehlivan||TC Erciyes University|