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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

Quadratus Lumborum Nerve Blocks for Myomectomies

Clinicaltrials.gov identifier NCT03935815

Recruitment Status Recruiting

First Posted May 2, 2019

Last update posted August 13, 2019

Study Description

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.

  • Condition or Disease:Laparoscopic Myomectomy
    Quadratus Lumborum Nerve Block
  • Intervention/Treatment: Drug: Ropivacaine injection
    Procedure: Sham treatment
  • Phase: Phase 1
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 1-2mg/kg 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 0.8-1 mg/kg 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 patient's hip for a semi-lateral position. 30 mL of 0.25% 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 mg/kg 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 (t=0), 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 2,600 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 Design
  • Study Type: Interventional
  • Estimated Enrollment: 90 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Quadratus Lumborum Nerve Blocks in Laparoscopic Myomectomy Patients
  • Actual Study Start Date: May 2019
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: December 2020
Arms and interventions
Arm Intervention/treatment
Active Comparator: Intervention
Standard of care pain management plus quadratus lumborum nerve block. Ropivicaine 0.25% 60 mL will be injected in the fascial plane between the quadratus lumborum muscle and transverses abdominus muscle.
Drug: Ropivacaine injection
30 mL of 0.25% 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.
Sham Comparator: Control
Standard of care pain management plus a sham procedure.
Procedure: Sham treatment
A sham procedure with a superficial 22 gauge needle stick will be performed without injectate.
Outcome Measures
  • Primary Outcome Measures: 1. Morphine equivalents (MOE) consumption [ Time Frame: Up to 24 hours after surgery ]
    The patient's cumulative intake of morphine over 24 hours.
  • Secondary Outcome Measures: 1. Pain Score [ Time Frame: Up to 48 hours after surgery ]
    Rate of pain on a scale of 0-10 (0 is no pain and 10 is the worst pain possible)
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- American Society of Anesthesiologists (ASA) physical status 1-2,

- Female,

- greater than or equal to 18 years of age,

- undergoing laparoscopic myomectomy surgery

Exclusion Criteria:

- History of chronic pain requiring preoperative opioids,

- congenital coagulopathy,

- anatomic abnormalities,

- localized soft tissue infection,

- use of anticoagulants,

- unable to comprehend pain scoring system,

- severely obese (BMI > 35)

Contacts and Locations
Contacts

Contact: Natale Naim, MD 310.267.8946 ndanino@mednet.ucla.edu

Locations

United States, California
Ronald Reagan UCLA Medical Center, Department of Anesthesiology
Los Angeles

Sponsors and Collaborators

University of California, Los Angeles

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