Nerve BlockNCT03771742
Modified Paramedic Sagittal vs. Transverse TMQLB
A study testing transverse scan, in-plane, posterior-anterior TMQLB and paramedian sagittal scan, in-plane, caudal-cranial TMQLB in people with Nerve Block, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The classical transmuscular qudratus lumborum block(TMQLB) described by Borglum aims to provide lower thoracic paravertebral space(PVS) and sympathetic blockade by injecting local anesthetics between QL and PM muscle at the L3-L4 vertebral level using a transverse scan, posterior-anterior, in-plane approach. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nerve Block
- What is being tested?
- transverse scan, in-plane, posterior-anterior TMQLB and paramedian sagittal scan, in-plane, caudal-cranial TMQLB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2018to 17 Feb 2019
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 yrs
- American Society of Anesthesiologists physical statusⅠ-Ⅲ
- 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
1 site in 1 country.
About this study
Official title: Randomized Prospective Study to Evaluate Cranial Dermatomal Spread of Modified Paramedic Sagittal Versus Transverse Approach TMQLB for Adrenal Surgery
The classical transmuscular qudratus lumborum block(TMQLB) described by Borglum aims to provide lower thoracic paravertebral space(PVS) and sympathetic blockade by injecting local anesthetics between QL and PM muscle at the L3-L4 vertebral level using a transverse scan, posterior-anterior, in-plane approach. Recently, a paramedian sagittal oblique(TMQLB) approach has been introduced to facilitate cranial spread by injecting the local in a caudal to cranial direction. Currently, there are no data comparing the two techniques mentioned above with regards to extent of spread for PVS. 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 TMQLB, paramedian sagittal scan, in-plane, caudal-cranial TMQLB
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 TMQLBProcedure or surgery
The patients will receive the transmuscular quadratus lumborum block(TMQLB) before surgery using the transverse scan, in-plain, posterior to anterior approach. 0.6ml/kg 0.375% ropivocaine is injected when the correct needle location is confirmed.
paramedian sagittal scan, in-plane, caudal-cranial TMQLBProcedure or surgery
The patients will receive the transmuscular quadratus lumborum block(TMQLB) before surgery using the paramedic sagittal scan, in-plain, caudal-cephalic approach.0.6ml/kg 0.375% ropivocaine is injected when the correct needle location is confirmed.
| Study group | Role | What they receive |
|---|---|---|
| transverse TMQLB | Active comparator | Patients in this group will receive the transmuscular quadratus lumborum block before surgery using the transverse scan, in-plain, posterior to anterior approach. 0.6ml 0.375% ropivocaine was injected when the correct needle location is confirmed. Receives: Procedure: transverse scan, in-plane, posterior-anterior TMQLB |
| paramedian sagittal TMQLB | Experimental | Patients in this group will receive the transmuscular quadratus lumborum block before surgery using the para-sagittal scan, in-plain, caudal to cephalic approach.0.6ml 0.375% ropivocaine was injected when the correct needle location is confirmed. Receives: Procedure: paramedian sagittal scan, in-plane, caudal-cranial TMQLB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cephalic sensory dermatomal spread
Measured: 20 minutes after block performance
Secondary outcomes (6)
Time to performance of procedure
Measured: Duration of procedure
Total sensory dermatomal spread
Measured: 20 minutes after block performance
Incidence of complication
Measured: Within 48hours after surgery
Caudal sensory dermatomal spread
Measured: 20 minutes after block performance
cumulative rate of rescue analgesics usage
Measured: At 0,2,4,8,12,24,48 hours after surgery
NRS pain scores
patients will evaluate their pain intensity with the numerical rating scale (NRS), where 0 indicates no pain, and 10 indicates the most severe pain.
Measured: At 0,2,4,8,12,24,48hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start15 Sep 2018
- Primary completion14 Feb 2019
- Study completion17 Feb 2019
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, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
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
- Investigators
- Xulei CUI, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03771742
- Sponsor's protocol ID
- cuixule6
- Status last verified
- Apr 2019
- First submitted
- 9 Dec 2018
- Last updated
- 16 Apr 2019
- 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 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Prospective Study to Evaluate Cranial Dermatomal Spread of Modified Paramedic Sagittal Versus Transverse Approach TMQLB for Adrenal Surgery
- ClinicalTrials.gov ID
- NCT03771742
- Acronym / sponsor ID
- cuixule6
- Conditions
- Nerve Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 14 Feb 2019 (actual)
- Study completion
- 17 Feb 2019 (actual)
- First posted
- 11 Dec 2018 (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.
The classical transmuscular qudratus lumborum block(TMQLB) described by Borglum aims to provide lower thoracic paravertebral space(PVS) and sympathetic blockade by injecting local anesthetics between QL and PM muscle at the L3-L4 vertebral level using a transverse scan, posterior-anterior, in-plane approach. Recently, a paramedian sagittal oblique(TMQLB) approach has been introduced to facilitate cranial spread by injecting the local in a caudal to cranial direction. Currently, there are no data comparing the two techniques mentioned above with regards to extent of spread for PVS. 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, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transverse TMQLB | Active comparator | Procedure: transverse scan, in-plane, posterior-anterior TMQLBPatients in this group will receive the transmuscular quadratus lumborum block before surgery using the transverse scan, in-plain, posterior to anterior approach. 0.6ml 0.375% ropivocaine was injected when the correct needle location is confirmed. |
| paramedian sagittal TMQLB | Experimental | Procedure: paramedian sagittal scan, in-plane, caudal-cranial TMQLBPatients in this group will receive the transmuscular quadratus lumborum block before surgery using the para-sagittal scan, in-plain, caudal to cephalic approach.0.6ml 0.375% ropivocaine was injected when the correct needle location is confirmed. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-70 yrs
- American Society of Anesthesiologists physical statusⅠ-Ⅲ
- Undergo laparoscopic adrenalectomy
- Informed consent
- Able to cooperate with study process
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 TMQLBThe patients will receive the transmuscular quadratus lumborum block(TMQLB) before surgery using the transverse scan, in-plain, posterior to anterior approach. 0.6ml/kg 0.375% ropivocaine is injected when the correct needle location is confirmed. | Procedure or surgery | transverse TMQLB |
| paramedian sagittal scan, in-plane, caudal-cranial TMQLBThe patients will receive the transmuscular quadratus lumborum block(TMQLB) before surgery using the paramedic sagittal scan, in-plain, caudal-cephalic approach.0.6ml/kg 0.375% ropivocaine is injected when the correct needle location is confirmed. | Procedure or surgery | paramedian sagittal TMQLB |
Primary outcome
Cephalic sensory dermatomal spread
Time frame: 20 minutes after block performance
6 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 48hours after surgery
Caudal sensory dermatomal spread
Time frame: 20 minutes after block performance
cumulative rate of rescue analgesics usage
Time frame: At 0,2,4,8,12,24,48 hours after surgery
NRS pain scores
Time frame: At 0,2,4,8,12,24,48hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
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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.
Xulei CUI principal investigator
Peking Union Medical College Hospital
1 site 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 TMQLB and paramedian sagittal scan, in-plane, caudal-cranial TMQLB in people with Nerve Block, run by Peking Union Medical College Hospital at 1 site 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: finished, as of the sponsor's last update on 16 Apr 2019. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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 16 Apr 2019.