Pain, PostoperativePhase 4NCT05480111

The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy

A Phase 4 study testing Local anesthesia at incision site and QL in people with Pain, Postoperative, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Pain, Postoperative
What is being tested?: Local anesthesia at incision site and QL
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 76 participants
Where: 1 siteUnited States
Study dates: 7 Sep 2022to 7 Apr 2023
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Texas Health Science Center at Houston
Houston, Texas, 77030

Other trials in United States

About this study

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

Conditions: Pain, Postoperative
Being tested: Local anesthesia at incision site, Sham QL, Sham Local, QL
Keywords: laparoscopy, hysterectomy
Medical subject headings: Pain, Postoperative

What participants receive

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

Local anesthesia at incision siteDrug
20 ml of 0.25% Bupivacaine will be given at incision site
Sham QLDrug
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
Sham LocalDrug
20 mls of normal saline given at incision site
QLDrug
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

Study groups in NCT05480111
Study group	Role	What they receive
QL Block	Experimental	Not described Receives: Drug: Sham Local; Drug: QL
Local Anesthesia at incision site	Active comparator	Not described Receives: Drug: Local anesthesia at incision site; Drug: Sham QL

What is being measured

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

Pain as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire
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.
Measured: 24 hours after anesthesia
Physical Comfort as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire
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.
Measured: 24 hours after anesthesia
Physical Independence as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire
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.
Measured: 24 hours after anesthesia
Psychological Support as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire
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.
Measured: 24 hours after anesthesia
Emotional State as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire
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.
Measured: 24 hours after anesthesia
Quality of Recovery as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire
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
Measured: 24 hours after anesthesia

Secondary outcomes (17)

Pain at Rest as Assessed by the Visual Analog Scale
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
Measured: Post anesthesia care unit (PACU) immediately postoperatively
Pain at Rest as Assessed by the Visual Analog Scale
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
Measured: At the time of first opiate administration(upto one day after surgery)
Pain at Rest as Assessed by the Visual Analog Scale
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
Measured: At the time of discharge (upto 3 days after surgery)
Pain at Rest as Assessed by the Visual Analog Scale
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
Measured: Day 1 (24+/=4 hours post surgery)
Pain at Dynamic as Assessed by the Visual Analog Scale
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
Measured: Day 1 (24+/=4 hours post surgery)
Pain at Rest as Assessed by the Visual Analog Scale
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
Measured: Day 14 post surgery
Pain at Dynamic as Assessed by the Visual Analog Scale
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
Measured: Day 14 post surgery
Pain at Rest as Assessed by the Visual Analog Scale
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
Measured: 6 weeks post surgery
Pain at Dynamic as Assessed by the Visual Analog Scale
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
Measured: 6 weeks post surgery
Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME)
Measured: in PACU(upto 8 hours after surgery)
Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME)
Measured: 24 hours after surgery
Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME)
Measured: 2 weeks post surgery
Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME)
Measured: 6 weeks post surgery
Time to Administration of First Pain Medication in PACU
Measured: 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
Measured: 30 days
Postoperative Nausea and Vomiting (PONV) Score Before Discharge
Postoperative Nausea and Vomiting (PONV) score before discharge
Scale: (none, mild, moderate)
Measured: about 24 hours
Time Needed to Administer the Intervention QL Block
Measured: Time to administration of intervention QL block

Timeline

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

7 Sep 20227 Apr 2023

First posted29 Jul 2022
Study start7 Sep 2022
Primary completion24 Feb 2023
Study completion7 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 4
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05480111
Sponsor's protocol ID: HSC-MS-22-0158
Status last verified: May 2024
First submitted: 28 Jun 2022
Last updated: 5 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Hui M, Mohr-Sasson A, Hernandez N, Bhalwal A, Montealegre A, Dziadek O, Leon M, Ghorayeb T, Pedroza C, Santos RB, Jalloul R. Effect of Preoperative Bilateral Ultrasound-Guided Quadratus Lumborum Nerve Block on Quality of Recovery After Minimally Invasive Hysterectomy in an Enhanced Recovery After Surgery (ERAS) Setting. J Minim Invasive Gynecol. 2024 Sep;31(9):769-777. doi: 10.1016/j.jmig.2024.05.019. Epub 2024 May 25.
PubMed 38797277

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy: A Blinded, Randomized Controlled Trial
ClinicalTrials.gov ID: NCT05480111
Acronym / sponsor ID: HSC-MS-22-0158
Conditions: Pain, Postoperative
Keywords: laparoscopy, hysterectomy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Study start: 7 Sep 2022 (actual)
Primary completion: 24 Feb 2023 (actual)
Study completion: 7 Apr 2023 (actual)
First posted: 29 Jul 2022 (actual)
Results: Posted 5 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
QL Block	Experimental	Drug: Sham Local, Drug: QL
Local Anesthesia at incision site	Active comparator	Drug: Local anesthesia at incision site, Drug: Sham QL

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Local anesthesia at incision site20 ml of 0.25% Bupivacaine will be given at incision site	Drug	Local Anesthesia at incision site
Sham QL20 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	Drug	Local Anesthesia at incision site
Sham Local20 mls of normal saline given at incision site	Drug	QL Block
QLQL 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	Drug	QL Block

Primary outcome

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.
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.
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.
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.
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.
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

17 secondary outcomes

Pain at Rest as Assessed by the Visual Analog Scale
Time frame: 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)
Pain at Rest as Assessed by the Visual Analog Scale
Time frame: 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)
Pain at Dynamic as Assessed by the Visual Analog Scale
Time frame: Day 1 (24+/=4 hours post surgery)
Pain at Rest as Assessed by the Visual Analog Scale
Time frame: Day 14 post surgery
Pain at Dynamic as Assessed by the Visual Analog Scale
Time frame: Day 14 post surgery
Pain at Rest as Assessed by the Visual Analog Scale
Time frame: 6 weeks post surgery
Pain at Dynamic as Assessed by the Visual Analog Scale
Time frame: 6 weeks post surgery
Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME)
Time frame: in PACU(upto 8 hours after surgery)
Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME)
Time frame: 24 hours after surgery
Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME)
Time frame: 2 weeks post surgery
Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME)
Time frame: 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)
Number of Participants With Complications Related to a Study Intervention
Time frame: 30 days
Postoperative Nausea and Vomiting (PONV) Score Before Discharge
Time frame: about 24 hours
Time Needed to Administer the Intervention QL Block
Time frame: Time to administration of intervention QL block

Results and safety

Results posted to the registry on 5 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
QL Block	38	29
Local Anesthesia at Incision Site	38	34

Primary outcome: Pain as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire

Time frame: 24 hours after anesthesia. Mean (Standard Deviation). Unit: score on a scale

Measure	Local Anesthesia at Incision Site n = 37	QL Block n = 32
Value	30.0 (2.8)	31.1 (2.2)

Population analysed: Data was not collected for 1 participant in the Local Anesthesia at incision site arm. Data was not collected for 6 participants in the QL block arm.

Primary outcome: Physical Comfort as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire

Time frame: 24 hours after anesthesia. Mean (Standard Deviation). Unit: score on a scale

Measure	Local Anesthesia at Incision Site n = 37	QL Block n = 32
Value	52.9 (4.9)	54.3 (5.1)

Population analysed: Data was not collected for 1 participant in the Local Anesthesia at incision site arm. Data was not collected for 6 participants in the QL block arm.

Primary outcome: Physical Independence as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire

Time frame: 24 hours after anesthesia. Mean (Standard Deviation). Unit: score on a scale

Measure	Local Anesthesia at Incision Site n = 37	QL Block n = 32
Value	20.4 (3.0)	21.3 (2.4)

Population analysed: Data was not collected for 1 participant in the Local Anesthesia at incision site arm. Data was not collected for 6 participants in the QL block arm.

Primary outcome: Psychological Support as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire

Time frame: 24 hours after anesthesia. Mean (Standard Deviation). Unit: score on a scale

Measure	Local Anesthesia at Incision Site n = 37	QL Block n = 32
Value	30.2 (2.8)	30.3 (1.7)

Population analysed: Data was not collected for 1 participant in the Local Anesthesia at incision site arm. Data was not collected for 6 participants in the QL block arm.

17 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 weeks post surgery. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
QL Block	0 of 38 (0%)	12 of 38 (31.6%)	0 of 38
Local Anesthesia at Incision Site	0 of 38 (0%)	14 of 38 (36.8%)	0 of 38

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38797277Hui M, Mohr-Sasson A, Hernandez N, Bhalwal A, Montealegre A, Dziadek O, Leon M, Ghorayeb T, Pedroza C, Santos RB, Jalloul R. Effect of Preoperative Bilateral Ultrasound-Guided Quadratus Lumborum Nerve Block on Quality of Recovery After Minimally Invasive Hysterectomy in an Enhanced Recovery After Surgery (ERAS) Setting. J Minim Invasive Gynecol. 2024 Sep;31(9):769-777. doi: 10.1016/j.jmig.2024.05.019. Epub 2024 May 25.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Randa J Jalloul, MD principal investigator

The University of Texas Health Science Center, Houston

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Local anesthesia at incision site and QL in people with Pain, Postoperative, run by The University of Texas Health Science Center, Houston 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 5 Jun 2024. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Pain as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire (time frame: 24 hours after anesthesia). The study lists 6 primary outcomes in all. 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 NCT05480111, which also lists 1 linked publication.

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 5 Jun 2024.