The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy

May 9, 2024 updated by: Randa Jalloul, The University of Texas Health Science Center, Houston

The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy: A Blinded, Randomized Controlled Trial

The purpose of this study is to compare quality of recovery as well as peri-operative systemic opiates use and pain scores in patients undergoing laparoscopic or robotic hysterectomy when local anesthetic versus Quadratus Lumborum nerve block (QL-2) is added to the standard pain management.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • English or Spanish speaking
  • American Society of Anesthesiologists (ASA) physical status 1-3
  • Planned laparoscopic or robotic hysterectomy

Exclusion Criteria:

  • History of chronic pain requiring preoperative opioids, Known alcoholism disorder
  • Congenital coagulopathy,
  • Localized soft tissue infection,
  • Use of anticoagulants,
  • Dementia, inability or refusal to provide consent for the surgery
  • Morbid obesity (BMI > 50), due to expected technical difficulty to achieve the block

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: QL Block
Drug: Sham Local
20 mls of normal saline given at incision site
Drug: QL
QL block involves injection of 19 ml of 0.25% Bupivacaine and iml(4mg) of Decadron in a fascial place formed partly by the posterior surface of the quadratus lumborum muscle.The QL block will be administered on both the right and left sides. The transducer is placed transverse immediately cranial to the iliac crest and at the level of the posterior axillary line. The needle is then inserted inplane from the lateral edge of the transducer and advanced through the quadratus lumborum (QL) muscle until the needle tip penetrated the epimysium of the anterior part of the QL muscle. The anesthetic is injected after repeated negative aspiration tests for blood in the fascial interspace between the QL and psoas major (PM) muscles posterior to the transversalis fascia
Active Comparator: Local Anesthesia at incision site
Drug: Local anesthesia at incision site
20 ml of 0.25% Bupivacaine will be given at incision site
Drug: Sham QL
20 mls of normal saline given at QL.The QL block will be administered on both the right and left sides. The transducer is placed transverse immediately cranial to the iliac crest and at the level of the posterior axillary line. The needle is then inserted inplane from the lateral edge of the transducer and advanced through the quadratus lumborum (QL) muscle until the needle tip penetrated the epimysium of the anterior part of the QL muscle. The anesthetic is injected after repeated negative aspiration tests for blood in the fascial interspace between the QL and psoas major (PM) muscles posterior to the transversalis fascia

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire
Time Frame: 24 hours after anesthesia
The QOR-40 questionnaire has 7 questions assessing pain with a maximum score of 35 and a minimum score of 5, a lower score indicating greater pain.
24 hours after anesthesia
Physical Comfort as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire
Time Frame: 24 hours after anesthesia
The QOR-40 questionnaire has 12 questions assessing physical comfort with a maximum score of 60 and a minimum score of 12, a lower score indicating a worst outcome.
24 hours after anesthesia
Physical Independence as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire
Time Frame: 24 hours after anesthesia
The QOR-40 questionnaire has 5 questions assessing physical independence, with a maximum score of 25 and a minimum score of 5, with a lower score indicating a worst outcome.
24 hours after anesthesia
Psychological Support as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire
Time Frame: 24 hours after anesthesia
The QOR-40 questionnaire has 7 questions assessing Psychological support, with a maximum score of 35 and a minimum score of 7, with a lower score indicating a worst outcome.
24 hours after anesthesia
Emotional State as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire
Time Frame: 24 hours after anesthesia
The QOR-40 questionnaire has 9 questions assessing emotional state, with a maximum score of 45 and a minimum score of 9, with a lower number indicating a worst outcome.
24 hours after anesthesia
Quality of Recovery as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire
Time Frame: 24 hours after anesthesia
The QOR-40 questionnaire has 40 questions with a total score from 40 (poorest quality of recovery) to 200 (best quality of recovery), with a higher score indicating a better outcome
24 hours after anesthesia

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain at Rest as Assessed by the Visual Analog Scale
Time Frame: Post anesthesia care unit (PACU) immediately postoperatively
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
Post anesthesia care unit (PACU) immediately postoperatively
Pain at Rest as Assessed by the Visual Analog Scale
Time Frame: At the time of first opiate administration(upto one day after surgery)
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
At the time of first opiate administration(upto one day after surgery)
Pain at Rest as Assessed by the Visual Analog Scale
Time Frame: At the time of discharge (upto 3 days after surgery)
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
At the time of discharge (upto 3 days after surgery)
Pain at Rest as Assessed by the Visual Analog Scale
Time Frame: Day 1 (24+/=4 hours post surgery)
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
Day 1 (24+/=4 hours post surgery)
Pain at Dynamic as Assessed by the Visual Analog Scale
Time Frame: Day 1 (24+/=4 hours post surgery)
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
Day 1 (24+/=4 hours post surgery)
Pain at Rest as Assessed by the Visual Analog Scale
Time Frame: Day 14 post surgery
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
Day 14 post surgery
Pain at Dynamic as Assessed by the Visual Analog Scale
Time Frame: Day 14 post surgery
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
Day 14 post surgery
Pain at Rest as Assessed by the Visual Analog Scale
Time Frame: 6 weeks post surgery
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
6 weeks post surgery
Pain at Dynamic as Assessed by the Visual Analog Scale
Time Frame: 6 weeks post surgery
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
6 weeks post surgery
Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME)
Time Frame: in PACU(upto 8 hours after surgery)
in PACU(upto 8 hours after surgery)
Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME)
Time Frame: 24 hours after surgery
24 hours after surgery
Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME)
Time Frame: 2 weeks post surgery
2 weeks post surgery
Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME)
Time Frame: 6 weeks post surgery
6 weeks post surgery
Time to Administration of First Pain Medication in PACU
Time Frame: From entry to Post anesthesia care unit (PACU) to time to administration of first pain medication in PACU (about 75 minutes)
From entry to Post anesthesia care unit (PACU) to time to administration of first pain medication in PACU (about 75 minutes)
Number of Participants With Complications Related to a Study Intervention
Time Frame: 30 days
30 days
Postoperative Nausea and Vomiting (PONV) Score Before Discharge
Time Frame: about 24 hours

Postoperative Nausea and Vomiting (PONV) score before discharge

Scale: (none, mild, moderate)
about 24 hours
Time Needed to Administer the Intervention QL Block
Time Frame: Time to administration of intervention QL block
Time to administration of intervention QL block

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Number of Participants That Required Morcellation
Time Frame: Intraoperative (about 3 hours)
Intraoperative (about 3 hours)
Specimen Weight
Time Frame: inoperative (about 3 hours)
inoperative (about 3 hours)
Duration of Surgery
Time Frame: about 3 hours
about 3 hours
Number of Participants That Were Discharge on the Same Day
Time Frame: Hospital discharge (up to 24 hours)
Hospital discharge (up to 24 hours)
Number of Participants for Which Lysis of Adhesions Took Greater Than 30 Minutes
Time Frame: about 3 hours
about 3 hours
Number of Participants With Intraoperative Complications
Time Frame: Intraoperative (about 3 hours)
Intraoperative (about 3 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center, Houston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Randa J Jalloul, MD, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 7, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 24, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 7, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSC-MS-22-0158

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings