- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05001802
Comparison of Two Techniques of Quadratus Lumborum Block
November 15, 2021 updated by: Cui Xulei, Peking Union Medical College Hospital
Transverse Versus Longitudinal Technique of Ultrasound-Guided Transmuscular Quadratus Lumborum Block:A Randomized Controlled Study Comparing Dermatomal Spread
Our objective is to investigate the extent of cranial dermatomal spread of transmuscular quadratus lumborum block(TMQLB )when equal dosage(ml/kg) of local anesthetic are injected with the transverse versus an modified paramedian sagittal approach for patients undergoing laparoscopic adrenalectomy.
Study Overview
Status
Recruiting
Conditions
Detailed Description
The paramedian sagittal oblique transmuscular quadratus lumborum block(TMQLB )approach has been introduced to facilitate cranial spread by injecting the local in a caudal to cranial direction compared with the transverse approach.
Currently, there are no data comparing the two techniques mentioned above with regards to extent of spread level.
Our objective is to investigate the extent of cranial dermatomal spread of TMQLB when equal dosage(ml/kg) of local anesthetic are injected with the transverse versus an modified paramedian sagittal approach for patients undergoing laparoscopic adrenalectomy.
In addition, the investigators wish to compare the performance time, caudal dermatomal spread of TMQLB and postoperative analgesia effect.
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
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
- Name: Xulei MD Cui
- Phone Number: +8613717739381
- Email: cuixulei10685@pumch.cn
Study Locations
-
-
-
Beijing, China
- Recruiting
- Peking Union Medical College Hospital
-
Contact:
- xulei cui, MD.
-
Beijing, China
- Not yet recruiting
- Peking Union Medical College Hospital
-
Contact:
- xulei cui, MD.
-
-
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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
≥Age 18yrs
- American Society of Anesthesiologists physical status I-II
- Undergo laparoscopic adrenalectomy
- Informed consent
- Able to cooperate with study process
Exclusion Criteria:
- Allergy to local anesthetic and other medications used in the study
- Patient refusal or lack of informed consent
- Coexisting hematological disorder or with deranged coagulation parameters
- Pre-existing major organ dysfunction such as hepatic and renal failure
- History of previous renal surgery.
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: transverse quadratus lumborum block
The patients will receive the transmuscular quadratus lumborum block before surgery using the transverse scan, in-plain, posterior to anterior approach.
0.6ml/kg 0.375% ropivacaine is injected when the correct needle location is confirmed.
|
transverse scan, in-plane, posterior- anterior quadratus lumborum block The patients will receive the transmuscular quadratus lumborum block before surgery using the transverse scan, in-plain, posterior to anterior approach.
0.6ml/kg 0.375% ropivacaine is injected when the correct needle location is confirmed.
Other Names:
|
|
Experimental: longitudinal quadratus lumborum block
The patients will receive the transmuscular quadratus lumborum block before surgery using the paramedic sagittal longitudinal scan, in-plain, caudal-cephalic approach.0.6ml/kg 0.375% ropivacaine is injected when the correct needle location is confirmed.
|
The patients will receive the transmuscular quadratus lumborum block before surgery using the paramedic sagittal longitudinal scan, in-plain, caudal-cephalic approach.0.6ml/kg 0.375% ropivacaine is injected when the correct needle location is confirmed.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cephalic sensory dermatomal spread
Time Frame: 20 minutes after block performance]
|
The pinprick method at the midclavicular line was used to assess the extent of the dermatomal blockade, 20 minutes following the completion of the procedure by a person who was blinded to group allocation.
The most cephalic dermatomal level that show a decreased pinprick sensation is recorded.A block failure was defined as the absence of any demonstrable sensory block 20 minutes after performance of the block.
|
20 minutes after block performance]
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to performance of procedure
Time Frame: Duration of procedure
|
Duration from needle insertion toward local anesthetic injection finished
|
Duration of procedure
|
|
Total sensory dermatomal spread
Time Frame: 20 minutes after block performance
|
The pinprick method at the midclavicular line was used to assess the extent of the dermatomal blockade, 20 minutes following the completion of the procedure by a person who was blinded to group allocation.
The total number of dermatomal levels that show decreased pinprick sensation is recorded.A block failure was defined as the absence of any demonstrable sensory block 20 minutes after performance of the block.
|
20 minutes after block performance
|
|
Incidence of complication
Time Frame: Within 48 hours after surgery
|
incidence of complication including bleeding, hematoma, infection at puncture site, local anesthetic poisoning, etc
|
Within 48 hours after surgery
|
|
Caudal sensory dermatomal spread
Time Frame: 20 minutes after block performance
|
The pinprick method at the midclavicular line was used to assess the extent of the dermatomal blockade, 20 minutes following the completion of the procedure by a person who was blinded to group allocation.
The most caudal dermatomal level that show a decreased pinprick sensation is recorded.A block failure was defined as the absence of any demonstrable sensory block 20 minutes after performance of the block.
|
20 minutes after block performance
|
|
rescue analgesics usage
Time Frame: At 0,12,24,48 hours after surgery
|
NSAIDs or opioids used for pain relief and their dosage
|
At 0,12,24,48 hours after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
August 20, 2021
Primary Completion (Actual)
November 16, 2021
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
May 19, 2021
First Submitted That Met QC Criteria
August 3, 2021
First Posted (Actual)
August 12, 2021
Study Record Updates
Last Update Posted (Actual)
November 17, 2021
Last Update Submitted That Met QC Criteria
November 15, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20210505
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.
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