Ignite Creation Date:
2024-05-06 @ 1:07 PM
Last Modification Date:
2024-10-26 @ 1:09 PM
Study NCT ID:
NCT03935815
Status:
TERMINATED
Last Update Posted:
2021-04-28
First Post:
2019-02-26
Brief Title:
Quadratus Lumborum Nerve Blocks for Myomectomies
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Quadratus Lumborum Nerve Blocks in Laparoscopic Myomectomy Patients
Status:
TERMINATED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Closed prior to completion secondary to surgeon leaving UCLA
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study would like to compare the use of the current standard of care in pain management for patients undergoing laparoscopic myomectomies to the addition of a quadratus lumborum nerve block plus the standard of care Patients will be consented and the nerve blocks will be placed after the patients are placed under general anesthesia Standard pain management will continue regardless of which arm of the study patients are in and measurements of pain scores narcotic usage and abdominal numbness will be assessed in the post-operative period
Detailed Description:
This study aims to investigate benefits to the use of quadratus lumborum nerve blocks for laparoscopic myomectomies Outcomes measured will be analgesic efficacy incidence of post-operative events patient satisfaction and narcotic usage
Once a patient meets eligibility criteria and has consented to enter the study randomization will be performed by the concealed envelope method If chosen to be in the intervention group a regional-trained anesthesiologist will perform the procedure different from the intra-operative anesthesiologist The control group will receive a superficial needle stick in the same location the quadratus lumborum block would have been otherwise placed
Pre-operative protocol
No premedications will be given while in the pre-operative waiting area A member of the study group will randomly chose a concealed envelope indicating whether the patient will be in the control or intervention group
Intraoperative protocol
All patients will have standard ASA monitoring including continuous electrocardiography non-invasive blood pressure percutaneous oxygen saturation end-tidal carbon dioxide measurements and heart rate
Induction of general anesthesia and endotracheal intubation will be performed with propofol 1-2mgkg and fentanyl 100 mcg Dexamethasone 10mg IV will be administered for all patients for post-operative nausea risk reduction
Maintenance of general anesthesia with be performed with sevoflurane 2-3 inhalation Rocuronium 08-1 mgkg intravenously will be administered for muscle relaxation
After the patient is intubated and hemodynamically stable the quadratus lumborum block procedure will be performed under ultrasound guidance by the regional trained anesthesiologist First a pillow or rolled blanket will be placed under the patients hip for a semi-lateral position 30 mL of 025 ropivacaine will be administered on both the right and left sides with a 20 gauge 4 inch ultrasound needle using a SonoSite ultrasound machine with a linear transducer probe The tip of the ultrasound needle will be placed posterior to the quadratus lumborum muscle QL2 made in the plane between the quadratus lumborum muscle and thoracolumbar fascia
After performing the block intra-operative fentanyl administration will be at the discretion of the intraoperative anesthesiologist On surgical closure acetaminophen 1000 mg IV and ketorolac 15mg IV will be administered No long acting opioids eg hydromorphone morphine will be given intra-operatively Ondansetron 4mg IV will be administered for post-operative nausea risk reduction Sugammadex 2 mgkg will be administered for reversal of neuromuscular blockade Extubation will be performed by the intra-operative anesthesiologist
Post-operative Protocol
Patients will be asked their pain scores at rest and with movement at the designated time intervals Arrival to PACU t0 1 hr 2hr 3hr and at PACU discharge Severity of pain will be on a 10-point Numeric Rating Scale NRS 0 no pain NRS 10 worst imaginable pain
A worksheet will be given to the patient at discharge and the patient will fill out her pain score 6 hours 24 hours and 48 hours after surgery Nursing staff will ask and record pain scores while in the PACU in the electronic medical system A study member will make phone calls home after PACU discharge to collect data from the patient
While in the PACU all patients will be ordered for intravenous fentanyl 25 mcg for mild pain fentanyl 50 mcg for moderate pain fentanyl 100 mcg for severe pain
Patients will be ordered for oxycodone PO 5mg for mild pain oxycodone PO 10mg for moderate pain oxycodone PO 15 mg for severe pain while in the recovery room
All patients will be discharged home with the same prescription of oxycodone 5mg one pill every 4 hours as needed All patients will be instructed to take acetaminophen 650mg every 6 hours by mouth for the first 24 hours 6 doses total 2600 mg for 24 hours as needed
It is currently not the standard of care to place these regional anesthesia nerve blocks but we do think they offer great value and are hoping to produce results which will change what the standard of care entails
Once a patient meets eligibility criteria and has consented to enter the study randomization will be performed by the concealed envelope method If chosen to be in the intervention group a regional-trained anesthesiologist will perform the procedure different from the intra-operative anesthesiologist The control group will receive a superficial needle stick in the same location the quadratus lumborum block would have been otherwise placed
Pre-operative protocol
No premedications will be given while in the pre-operative waiting area A member of the study group will randomly chose a concealed envelope indicating whether the patient will be in the control or intervention group
Intraoperative protocol
All patients will have standard ASA monitoring including continuous electrocardiography non-invasive blood pressure percutaneous oxygen saturation end-tidal carbon dioxide measurements and heart rate
Induction of general anesthesia and endotracheal intubation will be performed with propofol 1-2mgkg and fentanyl 100 mcg Dexamethasone 10mg IV will be administered for all patients for post-operative nausea risk reduction
Maintenance of general anesthesia with be performed with sevoflurane 2-3 inhalation Rocuronium 08-1 mgkg intravenously will be administered for muscle relaxation
After the patient is intubated and hemodynamically stable the quadratus lumborum block procedure will be performed under ultrasound guidance by the regional trained anesthesiologist First a pillow or rolled blanket will be placed under the patients hip for a semi-lateral position 30 mL of 025 ropivacaine will be administered on both the right and left sides with a 20 gauge 4 inch ultrasound needle using a SonoSite ultrasound machine with a linear transducer probe The tip of the ultrasound needle will be placed posterior to the quadratus lumborum muscle QL2 made in the plane between the quadratus lumborum muscle and thoracolumbar fascia
After performing the block intra-operative fentanyl administration will be at the discretion of the intraoperative anesthesiologist On surgical closure acetaminophen 1000 mg IV and ketorolac 15mg IV will be administered No long acting opioids eg hydromorphone morphine will be given intra-operatively Ondansetron 4mg IV will be administered for post-operative nausea risk reduction Sugammadex 2 mgkg will be administered for reversal of neuromuscular blockade Extubation will be performed by the intra-operative anesthesiologist
Post-operative Protocol
Patients will be asked their pain scores at rest and with movement at the designated time intervals Arrival to PACU t0 1 hr 2hr 3hr and at PACU discharge Severity of pain will be on a 10-point Numeric Rating Scale NRS 0 no pain NRS 10 worst imaginable pain
A worksheet will be given to the patient at discharge and the patient will fill out her pain score 6 hours 24 hours and 48 hours after surgery Nursing staff will ask and record pain scores while in the PACU in the electronic medical system A study member will make phone calls home after PACU discharge to collect data from the patient
While in the PACU all patients will be ordered for intravenous fentanyl 25 mcg for mild pain fentanyl 50 mcg for moderate pain fentanyl 100 mcg for severe pain
Patients will be ordered for oxycodone PO 5mg for mild pain oxycodone PO 10mg for moderate pain oxycodone PO 15 mg for severe pain while in the recovery room
All patients will be discharged home with the same prescription of oxycodone 5mg one pill every 4 hours as needed All patients will be instructed to take acetaminophen 650mg every 6 hours by mouth for the first 24 hours 6 doses total 2600 mg for 24 hours as needed
It is currently not the standard of care to place these regional anesthesia nerve blocks but we do think they offer great value and are hoping to produce results which will change what the standard of care entails
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None