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Laparoscopic MyomectomyPhase 1NCT03935815

Quadratus Lumborum Nerve Blocks for Myomectomies

A Phase 1 study testing Ropivacaine injection in people with Laparoscopic Myomectomy and Quadratus Lumborum Nerve Block, run by University of California, Los Angeles at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Ropivacaine injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
26 participants
Where
1 siteUnited States
Study dates
1 May 2019to 8 Jun 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • American Society of Anesthesiologists (ASA) physical status 1-2,
  • Female,
  • greater than or equal to 18 years of age,
  • undergoing laparoscopic myomectomy surgery

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Ronald Reagan UCLA Medical Center, Department of Anesthesiology

    Los Angeles, California, 90095

Other trials in United States

About this study

Official title: Quadratus Lumborum Nerve Blocks in Laparoscopic Myomectomy Patients

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.

Read the 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.

Being tested
Ropivacaine injection, Sham treatment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ropivacaine injectionDrug

    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 treatmentProcedure or surgery

    A sham procedure with a superficial 22 gauge needle stick will be performed without injectate.

Study groups in NCT03935815
Study groupRoleWhat they receive
InterventionActive comparatorStandard 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.
Receives: Drug: Ropivacaine injection
ControlSham comparatorStandard of care pain management plus a sham procedure.
Receives: Procedure: Sham treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Morphine equivalents (MOE) consumption

    The patient's cumulative intake of morphine over 24 hours.

    Measured: Up to 24 hours after surgery

Secondary outcomes (1)
  1. Pain Score

    Rate of pain on a scale of 0-10 (0 is no pain and 10 is the worst pain possible)

    Measured: Up to 48 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2019
  2. Study start1 May 2019
  3. Primary completion6 Jun 2020
  4. Study completion8 Jun 2020

Why it stopped: Closed prior to completion secondary to surgeon leaving UCLA

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03935815
Sponsor's protocol ID
18-000825
Status last verified
Apr 2021
First submitted
26 Feb 2019
Last updated
28 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.

    PubMed 26225500
  • Kadam VR. Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):550-2. doi: 10.4103/0970-9185.119148.

    PubMed 24249997
  • Carvalho R, Segura E, Loureiro MD, Assuncao JP. [Quadratus lumborum block in chronic pain after abdominal hernia repair: case report]. Rev Bras Anestesiol. 2017 Jan-Feb;67(1):107-109. doi: 10.1016/j.bjan.2014.08.001. Epub 2014 Dec 6. Portuguese.

    PubMed 25487690
  • Visoiu M, Yakovleva N. Continuous postoperative analgesia via quadratus lumborum block - an alternative to transversus abdominis plane block. Paediatr Anaesth. 2013 Oct;23(10):959-61. doi: 10.1111/pan.12240. Epub 2013 Aug 9.

    PubMed 23927552
  • Chakraborty A, Goswami J, Patro V. Ultrasound-guided continuous quadratus lumborum block for postoperative analgesia in a pediatric patient. A A Case Rep. 2015 Feb 1;4(3):34-6. doi: 10.1213/XAA.0000000000000090.

    PubMed 25642956

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ropivacaine injection in people with Laparoscopic Myomectomy and Quadratus Lumborum Nerve Block, run by University of California, Los Angeles at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Closed prior to completion secondary to surgeon leaving UCLA). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Morphine equivalents (MOE) consumption (time frame: Up to 24 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03935815, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.

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