Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to investigate the use of the erector spinae (ESP) block in reducing the morphine milligram equivalent (MME) consumption post percutaneous nephrolithotomy. Objectives:
This is a double-blind, randomized control trial involving 128 subjects undergoing an elective percutaneous nephrolithotomy. All subjects who meet all inclusion and exclusion criteria will be equally randomized on the day of the procedure by operating room pharmacy into either the ESP block or the control block. An interim analysis at the sample size required for a large effect size (n = 52, with n = 26 in each treatment arm) will be performed. In order to blind the anesthesiologist performing the block, the control arm will be equally randomized by the pharmacist at the time of distributing the pre-filled syringes for the ESP block procedure. Randomization will occur with the use of a random number generator with 1:1 ESP:Control allocation ratio.
Subjects will be followed at Pre-op and the 24-h, 48-h, 7 days and 30 days post operatively to assess the quality of recovery utilizing the Quality of Recovery-15 (QoR-15) questionnaire, VAS pain scale, and opioid consumption. Intraoperative MMEs, PACU MMEs, total MME's, FLACC scores at 30 minutes/1 hour VAS scores at 1 hour/2 hours/6 hours/24 hours, PACU LOS, hospital LOS, time to first flatus will be documented in patient chart, reviewed by study personnel and uploaded into a password protected database on the UTMCK server.
All aspects of the study and consent forms will be IRB approved prior to implementation. Potential candidates will be selected for consent based on chart review and surgery scheduling.
ESP
Active group:
1. One 30mL syringe containing 30mL of 0.5% ropivacaine- labeled "wound infiltration" 2. One 30mL syringe containing 30mL of preservative free normal saline- labeled "ESP Block"
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESP Group | Active Comparator | One 30mL syringe containing 30mL of 0.5% ropivacaine and 4 mg of dexamethosone- |
|
| Sham Group | Sham Comparator | One 30mL syringe containing 30mL of preservative free normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erector Spinae Plane Block | Procedure | The Anesthesiologist will use ultrasound-guided technique and inject 30mL of 0.5% ropivacaine with 4 mg of dexamethasone or saline placebo control into the erector spinae muscle, superficial to the tips of the thoracic transverse processes |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid consumption (MME) | Opioid consumption (MME) in the first 24 hours postoperative | First 24 hours postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital LOS | Hospital length of stay | Number of days in hospital (inpatient) from day of surgery (day 1) until discharge post-surgery in 24 hour increments up to 30 days |
| VAS score | Mean Visual Analog Scale (VAS) score in the first 24 hours after surgery. VAS measures the amount of pain that a patient feels ranging across a continuum from none(0) to an extreme amount of pain(10) on a chart. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jason Buehler, MD | Contact | 865-305-9220 | jbuehler@utmck.edu | |
| Aimee Pehrson | Contact | 865-305-5432 | apehrson@utmck.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jason Buehler, MD | University of Tennessee Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tennessee Medical Center | Recruiting | Knoxville | Tennessee | 37920 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29681047 | Background | Dundar G, Gokcen K, Gokce G, Gultekin EY. The Effect of Local Anesthetic Agent Infiltration Around Nephrostomy Tract On Postoperative Pain Control After Percutaneous Nephrolithotomy: A single-centre, randomised, double-blind, placebocontrolled clinical trial. Urol J. 2018 Nov 17;15(6):306-312. doi: 10.22037/uj.v0i0.4145. | |
| 30621377 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 1, 2021 | Aug 2, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 1, 2021 | Aug 2, 2021 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Ropivacaine 0.5% Injectable Solution | Drug | The Anesthesiologist will use ultrasound-guided technique and inject 30mL of 0.5% ropivacaine with 4 mg of dexamethasone or saline placebo control into the erector spinae muscle, superficial to the tips of the thoracic transverse processes |
|
| Dexamethasone | Drug | The Anesthesiologist will use ultrasound-guided technique and inject 30mL of 0.5% ropivacaine with 4 mg of dexamethasone or saline placebo control into the erector spinae muscle, superficial to the tips of the thoracic transverse processes |
|
| First 24 hours after surgery. |
| Opioid use during first 24 hours after surgery | MMEs (morphine milligram equivalent) administered during first 24 hours post surgery | 24 hours |
| QoR-15 | Quality of Recovery -15 at 24 hours, 48 hours, 7 days, and 30 days after surgery. QoR-15 measures how a patient feels they are recovering after surgery using a 15 item survey rated 0 (none of the time-poor) to 10 (all of the time-excellent). | 24 hours, 48 hours, 7 days, and 30 days after surgery |
| Opioid use during 30 days post hospital discharge | MMEs administered/consumed during 30 day period post hospital discharge | 30 days |
| De Cassai A, Bonvicini D, Correale C, Sandei L, Tulgar S, Tonetti T. Erector spinae plane block: a systematic qualitative review. Minerva Anestesiol. 2019 Mar;85(3):308-319. doi: 10.23736/S0375-9393.18.13341-4. Epub 2019 Jan 4. |
| 29940470 | Background | Tulgar S, Selvi O, Ozer Z. Clinical experience of ultrasound-guided single and bi-level erector spinae plane block for postoperative analgesia in patients undergoing thoracotomy. J Clin Anesth. 2018 Nov;50:22-23. doi: 10.1016/j.jclinane.2018.06.034. Epub 2018 Jun 23. No abstract available. |
| 31044575 | Background | Kwon WJ, Bang SU, Sun WY. Erector Spinae Plane Block for Effective Analgesia after Total Mastectomy with Sentinel or Axillary Lymph Node Dissection: a Report of Three Cases. J Korean Med Sci. 2018 Nov 5;33(45):e291. doi: 10.3346/jkms.2018.33.e291. No abstract available. |
| 31620856 | Background | Ibrahim M, Elnabtity AM. Analgesic efficacy of erector spinae plane block in percutaneous nephrolithotomy : A randomized controlled trial. Anaesthesist. 2019 Nov;68(11):755-761. doi: 10.1007/s00101-019-00673-w. Epub 2019 Oct 16. |
| 32267041 | Background | Govender S, Mohr D, Van Schoor AN, Bosenberg A. The extent of cranio-caudal spread within the erector spinae fascial plane space using computed tomography scanning in a neonatal cadaver. Paediatr Anaesth. 2020 Jun;30(6):667-670. doi: 10.1111/pan.13864. Epub 2020 Apr 22. |
| 17523902 | Background | Ugras MY, Toprak HI, Gunen H, Yucel A, Gunes A. Instillation of skin, nephrostomy tract, and renal puncture site with ropivacaine decreases pain and improves ventilatory function after percutaneous nephrolithotomy. J Endourol. 2007 May;21(5):499-503. doi: 10.1089/end.2006.0335. |
| 30292068 | Result | Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3. |
| D000588 |
| Amines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |