Nerve BlockNCT05001802
Comparison of Two Techniques of Quadratus Lumborum Block
A study testing transverse scan, in-plane, posterior- anterior quadratus lumborum block and paramedian sagittal longitudinal scan, in-plane, caudal-cranial quadratus lumborum block in people with Nerve Block, run by Peking Union Medical College Hospital at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nerve Block
- What is being tested?
- transverse scan, in-plane, posterior- anterior quadratus lumborum block and paramedian sagittal longitudinal scan, in-plane, caudal-cranial quadratus lumborum block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesChina
- Study dates
- 20 Aug 2021to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥Age 18yrs
- American Society of Anesthesiologists physical status I-II
- Undergo laparoscopic adrenalectomy
- Informed consent
- Able to cooperate with study process
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Not yet recruiting
Peking Union Medical College Hospital
Beijing
xulei cui, MD.
- Recruiting
Peking Union Medical College Hospital
Beijing
xulei cui, MD.
About this study
Official title: 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.
Read the 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.
- Conditions
- Nerve Block
- Being tested
- transverse scan, in-plane, posterior- anterior quadratus lumborum block, paramedian sagittal longitudinal scan, in-plane, caudal-cranial quadratus lumborum block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transverse scan, in-plane, posterior- anterior quadratus lumborum blockProcedure or surgery
Also called drug:ropivacaine
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.
paramedian sagittal longitudinal scan, in-plane, caudal-cranial quadratus lumborum blockProcedure or surgery
Also called drug:ropivacaine
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.
| Study group | Role | What they receive |
|---|---|---|
| transverse quadratus lumborum block | Active comparator | 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. Receives: Procedure: transverse scan, in-plane, posterior- anterior quadratus lumborum block |
| longitudinal quadratus lumborum block | Experimental | 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. Receives: Procedure: paramedian sagittal longitudinal scan, in-plane, caudal-cranial quadratus lumborum block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cephalic sensory dermatomal spread
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.
Measured: 20 minutes after block performance]
Secondary outcomes (5)
Time to performance of procedure
Duration from needle insertion toward local anesthetic injection finished
Measured: Duration of procedure
Total sensory dermatomal spread
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.
Measured: 20 minutes after block performance
Incidence of complication
incidence of complication including bleeding, hematoma, infection at puncture site, local anesthetic poisoning, etc
Measured: Within 48 hours after surgery
Caudal sensory dermatomal spread
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.
Measured: 20 minutes after block performance
rescue analgesics usage
NSAIDs or opioids used for pain relief and their dosage
Measured: At 0,12,24,48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start20 Aug 2021
- Primary completion16 Nov 2021
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve BlockStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cui Xulei, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05001802
- Sponsor's protocol ID
- 20210505
- Status last verified
- Nov 2021
- First submitted
- 19 May 2021
- Last updated
- 17 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transverse Versus Longitudinal Technique of Ultrasound-Guided Transmuscular Quadratus Lumborum Block:A Randomized Controlled Study Comparing Dermatomal Spread
- ClinicalTrials.gov ID
- NCT05001802
- Acronym / sponsor ID
- 20210505
- Conditions
- Nerve Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 16 Nov 2021 (actual)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transverse quadratus lumborum block | Active comparator | Procedure: transverse scan, in-plane, posterior- anterior quadratus lumborum blockThe 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. |
| longitudinal quadratus lumborum block | Experimental | Procedure: paramedian sagittal longitudinal scan, in-plane, caudal-cranial quadratus lumborum blockThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥Age 18yrs
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| transverse scan, in-plane, posterior- anterior quadratus lumborum blockAlso: drug:ropivacainetransverse 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. | Procedure or surgery | transverse quadratus lumborum block |
| paramedian sagittal longitudinal scan, in-plane, caudal-cranial quadratus lumborum blockAlso: drug:ropivacaineThe 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. | Procedure or surgery | longitudinal quadratus lumborum block |
Primary outcome
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.
5 secondary outcomes
Time to performance of procedure
Time frame: Duration of procedure
Total sensory dermatomal spread
Time frame: 20 minutes after block performance
Incidence of complication
Time frame: Within 48 hours after surgery
Caudal sensory dermatomal spread
Time frame: 20 minutes after block performance
rescue analgesics usage
Time frame: At 0,12,24,48 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transverse scan, in-plane, posterior- anterior quadratus lumborum block and paramedian sagittal longitudinal scan, in-plane, caudal-cranial quadratus lumborum block in people with Nerve Block, run by Peking Union Medical College Hospital at 2 sites in China.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xulei MD Cui (+8613717739381, cuixulei10685@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cephalic sensory dermatomal spread (time frame: 20 minutes after block performance]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Nov 2021.