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Completed

NCT Number: NCT03652103

Efficiency of Erector Spinae Plane Block For Patients Undergoing Percutaneous Nephrolithotomy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Izmir Bozyaka Training and Research Hospital

Karabağlar, İzmir, 35170, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound Guided Erector Spinae Plane Block Catheterisation

Procedure

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.

Bupivacaine 0.25% Injectable Solution

Drug

Perineural Injection

Other names: Marcain

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bozyaka Training and Research Hospital

Other

Registry information

Official study title

Efficiency of Erector Spinae Plane Block For Patients Undergoing Percutaneous Nephrolithotomy: A Prospective, Randomized, Controlled, Single Blind Study

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 29, 2018
Registry last updated
Apr 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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