Nerve BlockPhase 4NCT03100994
Post-operative Analgesia Efficacy Using Ultrasound-guided Transmuscular Quadratus Lumborum Block Versus Ultrasound-guided Quadratus Lumborum Type II Block.
A Phase 4 study testing Bupivacaine and Ultrasound in people with Nerve Block, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial summary
Post-operative analgesia efficacy using ultrasound-guided transmuscular quadratus lumborum block versus ultrasound-guided quadratus lumborum type II block Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Nerve Block
- What is being tested?
- Bupivacaine and Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Mar 2017to Jul 2018
- Phase
- Phase 4
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists classification (ASA) 1~3
- adequate communication skills
- Body mass index < 32
Who cannot join
- chronic pain neurological illness/ neuropathy contraindication against local anesthetics
Trial locations and contacts
1 site in 1 country.
Hsuan-Cheng Wu, Dr. contact
Taiwan1 site, 1 recruiting
- Recruiting
Tri-Service General Hospital
Taipei, 114
Shih-Hua Lin, PhD.
About this study
Post-operative analgesia efficacy using ultrasound-guided transmuscular quadratus lumborum block versus ultrasound-guided quadratus lumborum type II block
Read the detailed description
The Quadratus Lumborum (QL) Block is an ultrasound-guided technique described by Rafael Blanco in 2007. The nerves to the lower abdominal wall can be anesthetized by injecting local anesthetics between the quadratus lumborum muscle and latissimus dorsi muscle, which is called quadratus lumborum type II block. 〝 Transmuscular quadratus lumborum block demonstrates that injectate spreads over the posterior abdominal wall to the psoas major muscle and includes the upper branches of the lumbar plexus.〞described by Adhikary in 2016. However there are no published reports comparing the 2 techniques. In our study, compared of ultrasound-guided QL2-blocks with transmuscular quadratus lumborum block to investigate analgesic consumption, pain level, opioid related side effects and mobilization.
- Conditions
- Nerve Block
- Being tested
- Bupivacaine, Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Marcaine
injecting anesthetics to different local
UltrasoundDevice
Also called Philp
Ultrasound guided nerve block
| Study group | Role | What they receive |
|---|---|---|
| Group A | No intervention | without nerve block |
| Group B | Active comparator | Ultrasound guided transmuscular quadratus lumborum block with 0.125% bupivacaine 30ml Receives: Drug: Bupivacaine; Device: Ultrasound |
| Group C | Active comparator | Ultrasound guided quadratus lumborum type 2 block with 0.125% bupivacaine 30ml Receives: Drug: Bupivacaine; Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
morphine consumption
morphine consumption
Measured: 48 hours
Secondary outcomes (4)
Severity of postoperative pain via visual analogue pain scale (VAS)
Total cumulative morphine dose in mg used in the first 48 hours after surgery
Measured: 48 hours
Nausea or vomiting
Severity of nausea or vomiting in the first 48 hours after surgery. Severe :3 Moderate:2 Mild:1 None: 0
Measured: 48 hours
time to mobilization
Time to mobile in the first 48 hours after surgery
Measured: 48 hours
Skin itch
Severity of skin itch in the first 48 hours after surgery. Severe :3 Moderate:2 Mild:1 None: 0
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start28 Mar 2017
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nerve BlockStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 3 group: Group A: without intervention; Group B: Ultrasound-guided transmuscular quadratus lumborum block; Group C: Ultrasound-guided quadratus lumborum type II block
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wu Hsuan-Cheng, Tri-Service General Hospital (TSGH)
- Investigators
- Hsuan-Cheng Wu, Principal investigator, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100994
- Sponsor's protocol ID
- 1-105-05-157
- Status last verified
- Mar 2017
- First submitted
- 24 Mar 2017
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Adhikary SD, El-Boghdadly K, Nasralah Z, Sarwani N, Nixon AM, Chin KJ. A radiologic and anatomic assessment of injectate spread following transmuscular quadratus lumborum block in cadavers. Anaesthesia. 2017 Jan;72(1):73-79. doi: 10.1111/anae.13647. Epub 2016 Oct 12.
PubMed 27730633Blanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):757-762. doi: 10.1097/AAP.0000000000000495.
PubMed 27755488
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Analgesia Efficacy Using Ultrasound-guided Transmuscular Quadratus Lumborum Block Versus Ultrasound-guided Quadratus Lumborum Type II Block.
- ClinicalTrials.gov ID
- NCT03100994
- Acronym / sponsor ID
- 1-105-05-157
- Conditions
- Nerve Block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 4 Apr 2017 (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.
Post-operative analgesia efficacy using ultrasound-guided transmuscular quadratus lumborum block versus ultrasound-guided quadratus lumborum type II block
Detailed description
The Quadratus Lumborum (QL) Block is an ultrasound-guided technique described by Rafael Blanco in 2007. The nerves to the lower abdominal wall can be anesthetized by injecting local anesthetics between the quadratus lumborum muscle and latissimus dorsi muscle, which is called quadratus lumborum type II block. 〝 Transmuscular quadratus lumborum block demonstrates that injectate spreads over the posterior abdominal wall to the psoas major muscle and includes the upper branches of the lumbar plexus.〞described by Adhikary in 2016. However there are no published reports comparing the 2 techniques. In our study, compared of ultrasound-guided QL2-blocks with transmuscular quadratus lumborum block to investigate analgesic consumption, pain level, opioid related side effects and mobilization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3 group: Group A: without intervention; Group B: Ultrasound-guided transmuscular quadratus lumborum block; Group C: Ultrasound-guided quadratus lumborum type II block
| Arm | Type | Receives |
|---|---|---|
| Group A | No intervention | –without nerve block |
| Group B | Active comparator | Drug: Bupivacaine, Device: UltrasoundUltrasound guided transmuscular quadratus lumborum block with 0.125% bupivacaine 30ml |
| Group C | Active comparator | Drug: Bupivacaine, Device: UltrasoundUltrasound guided quadratus lumborum type 2 block with 0.125% bupivacaine 30ml |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists classification (ASA) 1~3
- adequate communication skills
- Body mass index < 32
Key exclusion criteria (1 listed)
- chronic pain neurological illness/ neuropathy contraindication against local anesthetics
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 |
|---|---|---|
| BupivacaineAlso: Marcaineinjecting anesthetics to different local | Drug | Group B, Group C |
| UltrasoundAlso: PhilpUltrasound guided nerve block | Device | Group B, Group C |
Primary outcome
morphine consumption
Time frame: 48 hours
morphine consumption
4 secondary outcomes
Severity of postoperative pain via visual analogue pain scale (VAS)
Time frame: 48 hours
Nausea or vomiting
Time frame: 48 hours
time to mobilization
Time frame: 48 hours
Skin itch
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Results publication: PubMed 27730633Adhikary SD, El-Boghdadly K, Nasralah Z, Sarwani N, Nixon AM, Chin KJ. A radiologic and anatomic assessment of injectate spread following transmuscular quadratus lumborum block in cadavers. Anaesthesia. 2017 Jan;72(1):73-79. doi: 10.1111/anae.13647. Epub 2016 Oct 12.
- Results publication: PubMed 27755488Blanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):757-762. doi: 10.1097/AAP.0000000000000495.
- Individual participant dataSharing planned: No
Related trials for Nerve Block
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Recruiting
Minimum Effective Local Anesthetic Volume for Ultrasound Guided Superior Trunk Block
Musculoskeletal Diseases or Conditions
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
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.
Hsuan-Cheng Wu, Dr. contact
Hsuan-Cheng Wu principal investigator
Tri-Service General Hospital (TSGH)
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 Bupivacaine and Ultrasound in people with Nerve Block, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
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 1 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 4 Apr 2017. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hsuan-Cheng Wu, Dr. (aibrain@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
morphine consumption (time frame: 48 hours). 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 NCT03100994, which also lists 2 linked publications.
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 4 Apr 2017.