Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficiency of Erector Spinae Plane Block For Patients Undergoing Percutaneous Nephrolithotomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03652103
Recruitment Status : Completed
First Posted : August 29, 2018
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Mehmet Uğur Bilgin, Bozyaka Training and Research Hospital

Brief Summary:

Investigators' goal is to determine whether Erector Spinae Plane Block would provide a better analgesia, help mobilization and early discharge or increase satisfaction for patients undergoing Percutaneous Nephrolithotomy(PNL).

One of the two groups will receive ESP catheterization after general anesthesia conducted. The other group will receive routine analgesia protocol used for PNL.

The total amount of drugs administered, pain scores(NRS) at certain time intervals and at certain events(removal of nephrostomy and pain at mobilization) will be recorded and compared.


Condition or disease Intervention/treatment Phase
Nephrolithotomy, Percutaneous Anesthetics, Local Nerve Block Erector Spinae Plane Block Pain, Postoperative Anesthesia and Analgesia Procedure: Ultrasound Guided Erector Spinae Plane Block Catheterisation Drug: Bupivacaine 0.25% Injectable Solution Phase 4

Detailed Description:

Erector Spinae Plane Block(ESP) is a rather new method which can block ventral and dorsal rami of spinal nerves in the paravertebral area after they leave the spinal column. Originally used for thoracic somites, by spreading in a craniocaudal fashion in the erector spinae muscle group, it has the potential of blocking cervical or lumbar nerves as well.

To provide better analgesia for surgical procedures, anesthesiologists use truncal blocks for peripheral intervention. Although these blocks are generally very effective and easy to apply, they are limited by a relatively small area of effectivity. In order to achieve denser effects for larger surfaces, epidural anesthesia must be used with the risk of more severe complications than any peripheral or truncal nerve blocks. Epidural anesthesia also has the disadvantages of requiring more experience and more cautiousness than ultrasound-guided truncal blocks and risks of an undesirable temporary motor blockade. ESP block could be the answer for better regional analgesia while avoiding motor blockade and complications of epidural anesthesia.

The study will have two groups as Block Group(GB) and Control Group(GC) and two periods as during operation and 48 hours after the operation. Every participant will receive Total Intravenous Anesthesia(TIVA) and will be monitored with ECG, non-invasive blood pressure, heart rate, pulse oximeter, and Bispectral Index. Participants in GB will receive ultrasound-guided ESP block catheter after proper maintenance of anesthesia provided. The first period will be during operation. We will evaluate the administered drug amounts per kilogram for each patient. Investigators believe ESP block will help them deliver proper anesthesia with lower dosages. The second period will include postoperative 48 hours. Pain scores(NRS) will be evaluated at certain time intervals and at two critical moments between the two groups. One of the critical moment which patients fear and feel the pain most is the removal time of nephrostomy. The second moment is the first time patients start walking.

Rescue analgesia will be ordered on demand for both groups as IV 1 mg/kg tramadol. Hours and amounts of rescue analgesia administered will be recorded.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two groups involved. First group will receive total intravenous anesthesia and erector spinae plane block catheter Second group will receive total intravenous anesthesia and routine analgesia protocol for percutaneous Nephrolithotomy procedures.
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Efficiency of Erector Spinae Plane Block For Patients Undergoing Percutaneous Nephrolithotomy: A Prospective, Randomized, Controlled, Single Blind Study
Actual Study Start Date : September 5, 2018
Actual Primary Completion Date : March 10, 2019
Actual Study Completion Date : March 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: GCont
Only dressing will be applied to patients without actually nerve catheter performed
Experimental: GBlock

Ultrasound Guided Erector Spinae Plane Block Catheter will be applied: 20ml Bupivacaine 0.25% Injectable Solution* will be administered initially.

20 ml Bupivacaine %0.25 Injectable Solution** will be administered 20 minutes before mobilization at postoperative day(POD) 1 and before removal of nephrostomy at POD 2

*10ml %0,5 Bupivacaine will be diluted with 10ml Saline solution.

Procedure: Ultrasound Guided Erector Spinae Plane Block Catheterisation
After receiving general anesthesia, patients will positioned prone. Before operation begins, ESP block catheter will be applied with ultrasound guidance to the same level as surgeon's incision.

Drug: Bupivacaine 0.25% Injectable Solution
Perineural Injection
Other Name: Marcain




Primary Outcome Measures :
  1. Dosage of Drugs [ Time Frame: During procedure ]
    Amounts of drugs per kilogram per hour will be recorded

  2. Post-operative pain assessed by Numeric Rating Scale (NRS) [ Time Frame: 30th minute postoperatively ]
    Pain scores will be recorded as reported by the patient according to NRS

  3. Post-operative pain assessed by Numeric Rating Scale (NRS) [ Time Frame: 60th minute postoperatively ]
    Pain scores will be recorded as reported by the patient according to NRS

  4. Post-operative pain assessed by Numeric Rating Scale (NRS) [ Time Frame: 2nd hour postoperatively ]
    Pain scores will be recorded as reported by the patient according to NRS

  5. Post-operative pain assessed by Numeric Rating Scale (NRS) [ Time Frame: 6th hour postoperatively ]
    Pain scores will be recorded as reported by the patient according to NRS

  6. Post-operative pain assessed by Numeric Rating Scale (NRS) [ Time Frame: 12th hour postoperatively ]
    Pain scores will be recorded as reported by the patient according to NRS

  7. Post-operative pain assessed by Numeric Rating Scale (NRS) [ Time Frame: 24th hour postoperatively ]
    Pain scores will be recorded as reported by the patient according to NRS

  8. Post-operative pain assessed by Numeric Rating Scale (NRS) [ Time Frame: 48th hour postoperatively ]
    Pain scores will be recorded as reported by the patient according to NRS

  9. Post-operative pain assessed by Numeric Rating Scale (NRS) [ Time Frame: Mobilisation at postoperative day (POD) 1 ]
    Pain scores will be recorded during the first steps as reported by the patient according to NRS

  10. Post-operative pain assessed by Numeric Rating Scale (NRS) [ Time Frame: At the time of removal of nephrostomy at postoperative day (POD) 2 ]
    Pain scores will be recorded during the procedure as reported by the patient according to NRS


Secondary Outcome Measures :
  1. Opioid Consumption [ Time Frame: 48 hour post-operatively ]
    Opioids(Tramadol) will be administered to patients in case demanded.

  2. Discharge [ Time Frame: 240 hours post-operatively ]
    Day of the discharge



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who are scheduled for percutaneous nephrolithotomy under total intravenous anesthesia
  • Patients who has informed consent for study
  • Patients with American Society of Anesthesiologists Physical Status Classification(ASA) I and II

Exclusion Criteria:

  • Patient's refusal to participate
  • Patients under 18 years of age
  • Patients who are undergoing surgery with an anesthesia technique other than total intravenous anesthesia for any reason (inhalation anesthesia, laryngeal mask application, etc.)
  • Patients with known local anesthetic allergy
  • Patients with Body mass index > 35
  • Patients diagnosed sepsis and bacteriemia,
  • Skin infection at the injection site,
  • Patients with previous spinal surgery
  • History of coagulopathy or anticoagulant therapy
  • Patients with uncontrolled diabetes ,
  • Uncoordinated patients,
  • Psychological and emotional lability,
  • Surgical intervention longer than 3 hours.

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): NCT03652103


Locations
Layout table for location information
Turkey
Izmir Bozyaka Training and Research Hospital
Karabaglar, İzmir, Turkey, 35170
Sponsors and Collaborators
Bozyaka Training and Research Hospital

Layout table for additonal information
Responsible Party: Mehmet Uğur Bilgin, Anesthesiology Resident, Bozyaka Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03652103    
Other Study ID Numbers: ESPforPNL
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mehmet Uğur Bilgin, Bozyaka Training and Research Hospital:
Truncal Nerve Blocks, Ultrasound Guided Nerve Blocks
Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents