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The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy

Primary Purpose

Pain, Postoperative

Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Local anesthesia at incision site
Sham QL
Sham Local
QL
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Postoperative focused on measuring laparoscopy, hysterectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

QL Block

Local Anesthesia at incision site

Arm Description

Outcomes

Primary Outcome Measures

Physical comfort as assessed by the Quality of Recovery (QOR-40) validated questionnaire
The QOR-40 questionnaire has 40 questions each one is scored from 1(none of the time) to 5(all of the time) for a total score of 200 a higher number indicating better quality
Physical independence as assessed by the Quality of Recovery (QOR-40) validated questionnaire
The QOR-40 questionnaire has 40 questions each one is scored from 1(none of the time) to 5(all of the time) for a total score of 200 a higher number indicating better quality
Emotional state as assessed by the Quality of Recovery (QOR-40) validated questionnaire
The QOR-40 questionnaire has 40 questions each one is scored from 1(none of the time) to 5(all of the time) for a total score of 200 a higher number indicating better quality
Psychological support as assessed by the Quality of Recovery (QOR-40) validated questionnaire
The QOR-40 questionnaire has 40 questions each one is scored from 1(none of the time) to 5(all of the time) for a total score of 200 a higher number indicating better quality
Pain as assessed by the Quality of Recovery (QOR-40) validated questionnaire
The QOR-40 questionnaire has 40 questions each one is scored from 1(none of the time) to 5(all of the time) for a total score of 200 a higher number indicating better quality

Secondary Outcome Measures

Pain at rest as assessed by the visual analog scale
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
Pain at rest as assessed by the visual analog scale
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
Pain at rest as assessed by the visual analog scale
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
Pain at rest as assessed by the visual analog scale
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
Pain at rest as assessed by the visual analog scale
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
Pain at rest as assessed by the visual analog scale
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
Amount of oral morphine consumed measured in morphine milliequivalents (OME)
Amount of oral morphine consumed measured in morphine milliequivalents (OME)
Amount of oral morphine consumed measured in morphine milliequivalents (OME)
Amount of oral morphine consumed measured in morphine milliequivalents (OME)

Full Information

First Posted
June 28, 2022
Last Updated
July 27, 2022
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT05480111
Brief Title
The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy
Official Title
The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy: A Blinded, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 27, 2022 (Anticipated)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
laparoscopy, hysterectomy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
QL Block
Arm Type
Experimental
Arm Title
Local Anesthesia at incision site
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Local anesthesia at incision site
Intervention Description
20 ml of 0.25% Bupivacaine will be given at incision site
Intervention Type
Drug
Intervention Name(s)
Sham QL
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Sham Local
Intervention Description
20 mls of normal saline given at incision site
Intervention Type
Drug
Intervention Name(s)
QL
Intervention Description
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
Primary Outcome Measure Information:
Title
Physical comfort as assessed by the Quality of Recovery (QOR-40) validated questionnaire
Description
The QOR-40 questionnaire has 40 questions each one is scored from 1(none of the time) to 5(all of the time) for a total score of 200 a higher number indicating better quality
Time Frame
24 hours after anesthesia
Title
Physical independence as assessed by the Quality of Recovery (QOR-40) validated questionnaire
Description
The QOR-40 questionnaire has 40 questions each one is scored from 1(none of the time) to 5(all of the time) for a total score of 200 a higher number indicating better quality
Time Frame
24 hours after anesthesia
Title
Emotional state as assessed by the Quality of Recovery (QOR-40) validated questionnaire
Description
The QOR-40 questionnaire has 40 questions each one is scored from 1(none of the time) to 5(all of the time) for a total score of 200 a higher number indicating better quality
Time Frame
24 hours after anesthesia
Title
Psychological support as assessed by the Quality of Recovery (QOR-40) validated questionnaire
Description
The QOR-40 questionnaire has 40 questions each one is scored from 1(none of the time) to 5(all of the time) for a total score of 200 a higher number indicating better quality
Time Frame
24 hours after anesthesia
Title
Pain as assessed by the Quality of Recovery (QOR-40) validated questionnaire
Description
The QOR-40 questionnaire has 40 questions each one is scored from 1(none of the time) to 5(all of the time) for a total score of 200 a higher number indicating better quality
Time Frame
24 hours after anesthesia
Secondary Outcome Measure Information:
Title
Pain at rest as assessed by the visual analog scale
Description
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
Time Frame
Post anesthesia care unit (PACU) immediately postoperatively
Title
Pain at rest as assessed by the visual analog scale
Description
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
Time Frame
At the time of first opiate administration(upto one day after surgery)
Title
Pain at rest as assessed by the visual analog scale
Description
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
Time Frame
At the time of discharge (upto 3 days after surgery)
Title
Pain at rest as assessed by the visual analog scale
Description
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
Time Frame
Day 1 (24+/=4 hours post surgery)
Title
Pain at rest as assessed by the visual analog scale
Description
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
Time Frame
Day 14 post surgery
Title
Pain at rest as assessed by the visual analog scale
Description
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
Time Frame
6 weeks post surgery
Title
Amount of oral morphine consumed measured in morphine milliequivalents (OME)
Time Frame
in PACU(upto 8 hours after surgery)
Title
Amount of oral morphine consumed measured in morphine milliequivalents (OME)
Time Frame
24 hours after surgery
Title
Amount of oral morphine consumed measured in morphine milliequivalents (OME)
Time Frame
2 weeks post surgery
Title
Amount of oral morphine consumed measured in morphine milliequivalents (OME)
Time Frame
6 weeks post surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Randa J Jalloul, MD
Phone
713-566-5749
Email
Randa.J.Jalloul@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sunbola S Ashimi Ademola
Phone
713-500-6410
Email
Sunbola.S.Ashimi@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randa J Jalloul, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Randa Jalloul, MD
Phone
713-566-5749
Email
Randa.J.Jalloul@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Sunbola S Ashimi Ademola
Phone
713-500-6410
Email
Sunbola.S.Ashimi@uth.tmc.edu

12. IPD Sharing Statement

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The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy

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