NCT03935815

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2020

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2020

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

1.1 years

First QC Date

February 26, 2019

Last Update Submit

April 26, 2021

Conditions

Laparoscopic MyomectomyQuadratus Lumborum Nerve Block

Outcome Measures

Primary Outcomes (1)

  • Morphine equivalents (MOE) consumption

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

    Up to 24 hours after surgery

Secondary Outcomes (1)

  • Pain Score

    Up to 48 hours after surgery

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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

Control

SHAM COMPARATOR

Standard of care pain management plus a sham procedure.

Procedure: Sham treatment

Interventions

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.

Intervention
Sham treatmentPROCEDURE

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

Control

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ronald Reagan UCLA Medical Center, Department of Anesthesiology

Los Angeles, California, 90095, United States

Location

Related Publications (5)

  • 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.

    PMID: 26225500RESULT

  • 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.

    PMID: 24249997RESULT

  • 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.

    PMID: 25487690RESULT

  • 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.

    PMID: 23927552RESULT

  • 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.

    PMID: 25642956RESULT

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 26, 2019

First Posted

May 2, 2019

Study Start

May 1, 2019

Primary Completion

June 6, 2020

Study Completion

June 8, 2020

Last Updated

April 28, 2021

Record last verified: 2021-04

Locations

US(1)