Quadratus Lumborum BlockPhase 4NCT05416866
Transversus Abdominis Plane Block Plus Quadratus Lumborum Block or Retrolaminar Block of Multiple Injections for Postoperative Analgesia Following Laparoscopic Colorectal Surgery
A Phase 4 study testing Retrolaminar block on the operative side, Quadratus lumborum block on the operative side and Transversus abdominis plane block on the nonoperative side in people with Quadratus Lumborum Block and Analgesia, run by dong zhang.
Trial summary
Our hypothesis was that transversus abdominis plane block plus retrolaminar block would reduce postoperative sufentanil consumption and provide superior analgesia compared with transversus abdominis plane block plus quadratus lumborum block for laparoscopic colorectal surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Quadratus Lumborum Block, Analgesia, Laparoscopic
- What is being tested?
- Retrolaminar block on the operative side, Quadratus lumborum block on the operative side and Transversus abdominis plane block on the nonoperative side
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2022to 30 Dec 2022
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I-II class
- Colorectal cancer patients
- 18 and 80 years old
- Elective laparoscopic colorectal surgery
Who cannot join
- serious complications associated with other systems:
- severe cardiac insufficiency
- renal failure
- hepatic encephalopathy
- infection in the block injection area
- coagulopathy
Show all 11Show fewer
- a known allergy to local anesthetics
- a previous history of tranquilizer or opioid abuse,
- body mass index (BMI) greater than 30 kg/m2 or less than 18 kg/m2,
- inability to cooperate with the assessment of visual analogue scale (VAS) pain scores
- refusal to participate in the study
About this study
Official title: Transversus Abdominis Plane Block Plus Quadratus Lumborum Block or Retrolaminar Block of Multiple Injections for Postoperative Analgesia Following Laparoscopic Colorectal Surgery: A Randomized, Double-blind, Controlled Trial
Our hypothesis was that transversus abdominis plane block plus retrolaminar block would reduce postoperative sufentanil consumption and provide superior analgesia compared with transversus abdominis plane block plus quadratus lumborum block for laparoscopic colorectal surgery.
- Conditions
- Quadratus Lumborum Block, Analgesia, Laparoscopic, Colorectal
- Being tested
- Retrolaminar block on the operative side, Quadratus lumborum block on the operative side, Transversus abdominis plane block on the nonoperative side
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrolaminar block on the operative sideProcedure or surgery
After the skin near the puncture site was disinfected, 2ml of 1% lidocaine was injected into the puncture site for local infiltration. The needle was inserted beneath the ultrasound probe using an in-plane orientation to contact the lamina of the T8-T11 vertebra. Then we retracted the tip of needle to the lamina about 1 mm and withdrew to make sure that there was no blood or cerebrospinal fluid. Then, 30-40 mL mixture was injected posterior to the lamina of T8-T11.
Quadratus lumborum block on the operative sideProcedure or surgery
In our study, we applied a transmuscular approach to the QLB. After the patients were placed in the lateral position, the skin near the puncture site was disinfected, a low-frequency (3-5 MHz), curvilinear probe is used and is located vertical to the iliac crest at the posterior axillary line to find the Shamrock sign. After the local infiltration for puncture site, the 22-G needle is then inserted in plane and directed to the QL muscle. After the proper position of the needle tip between the psoas major muscle and the QL muscle is confirmed, 30 ml mixture is injected into the interfascial plane.
Transversus abdominis plane block on the nonoperative sideProcedure or surgery
After placing the patients in the supine position, the skin was disinfected. A linear probe was placed in the transverse plane at the midaxillary line between the lower costal margin and iliac crest. When the external oblique, internal oblique, and transversus abdominis muscles were observed, 2ml of 1% lidocaine was injected into the puncture site for local infiltration.Then, a 22-gauge, 80-mm needle was advanced using an in-plane technique in an anteromedial to posterolateral direction toward the TAP (the fascial plane between the internal oblique and transversus abdominis muscles). After the correct position of the needle tip was verified, 20 ml mixture was injected into the TAP. The ultrasound showed that the local anesthetic separated the internal oblique and transversus abdominis muscles, confirming the success of the block.
| Study group | Role | What they receive |
|---|---|---|
| TR group | Experimental | ultrasound-guided transversus abdominis plane block with 20 ml mixture 0.20% ropivacaine + dexamethasone 5 mg and retrolaminar block with 30-40 ml mixture 0.20% ropivacaine + dexamethasone 5 mg Receives: Procedure: Retrolaminar block on the operative side; Procedure: Transversus abdominis plane block on the nonoperative side |
| TQ group | Experimental | ultrasound-guided transversus abdominis plane block with 20 ml mixture 0.20% ropivacaine + dexamethasone 5 mg and quadratus lumborum block with 30 ml mixture 0.20% ropivacaine + dexamethasone 5 mg Receives: Procedure: Quadratus lumborum block on the operative side; Procedure: Transversus abdominis plane block on the nonoperative side |
What is being measured
The primary outcome is the main question the study is designed to answer.
the cumulative consumption of sufentanil
the outcome in micrograms
Measured: 24 hours after nerves block
Secondary outcomes (11)
the patient's mean arterial pressure (MAP), HR at rest and during movement at 1, 2, 4, 6, 8, 12, 18, 24 after nerves block
MAP in mmHg, HR in rate/one minute.
Measured: the time for completion of nerves block was time 0
cumulative sufentanil consumption at predetermined time intervals
the outcome in minutes
Measured: within 24 hour after nerves block
time until the earliest single patient-controlled analgesia (PCA) dose of sufentanil
the outcome in minutes
Measured: within 24 hour after nerves block
the number of PCA press
the outcome in frequency
Measured: within 24 hour after nerves block
time until the earliest rescue analgesia and antiemetic
the outcome in minutes
Measured: within 24 hour after nerves block
the total dose of rescue analgesia and antiemetic
the outcome in milligrams
Measured: within 24 hour after nerves block
block-related complications
such as hematoma, infection, quadriceps weakness, pneumothorax, deep visceral injury, and evidence of systemic toxicity to the local anesthetic
Measured: within 24 hour after nerves block
other side events
such as bradycardia (HR less than 60 beats per min), hypotension (systolic blood pressure less than 90 mmHg or more than 20% lower than baseline), hypoxemia (SpO2 less than 90%), respiratory depression (RR less than 10 breaths per min lasting for more than 10 min), pruritus, backache, nausea and vomiting
Measured: within 24 hour after nerves block
patient satisfaction with pain management
Patient satisfaction on postoperative analgesia using a 5-point scale (1 = very unsatisfied, 2 = unsatisfied, 3 = fair, 4 = satisfied, and 5 = very satisfied)
Measured: at 24th hour after nerves block
the length of hospital stay
the outcome in days
Measured: up to 2 weeks
Visual Analog Score (VAS) for pain at rest and during movement at 1, 2, 4, 6, 8, 12, 18, 24 after nerves block
The VAS is an internationally recognized scale for assessment of pain on an 11-point scale ranging from 0 to 10 points, with 0 defined as no pain and 10 defined as the worst pain imaginable (units on a scale)
Measured: the time for completion of nerves block was time 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start20 Jun 2022 (estimated)
- Primary completion20 Nov 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quadratus Lumborum 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
- Parallel groups
- Model description
- A randomized, double-blind, controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- dong zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, dong zhang, Gansu Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416866
- Sponsor's protocol ID
- GanSu Province
- Status last verified
- Jun 2022
- First submitted
- 26 May 2022
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transversus Abdominis Plane Block Plus Quadratus Lumborum Block or Retrolaminar Block of Multiple Injections for Postoperative Analgesia Following Laparoscopic Colorectal Surgery: A Randomized, Double-blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT05416866
- Acronym / sponsor ID
- GanSu Province
- Conditions
- Quadratus Lumborum Block, Analgesia, Laparoscopic, Colorectal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- dong zhangUniversity, hospital or other
- Study start
- 20 Jun 2022 (estimated)
- Primary completion
- 20 Nov 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 14 Jun 2022 (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 hypothesis was that transversus abdominis plane block plus retrolaminar block would reduce postoperative sufentanil consumption and provide superior analgesia compared with transversus abdominis plane block plus quadratus lumborum block for laparoscopic colorectal surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, double-blind, controlled trial
| Arm | Type | Receives |
|---|---|---|
| TR group | Experimental | Procedure: Retrolaminar block on the operative side, Procedure: Transversus abdominis plane block on the nonoperative sideultrasound-guided transversus abdominis plane block with 20 ml mixture 0.20% ropivacaine + dexamethasone 5 mg and retrolaminar block with 30-40 ml mixture 0.20% ropivacaine + dexamethasone 5 mg |
| TQ group | Experimental | Procedure: Quadratus lumborum block on the operative side, Procedure: Transversus abdominis plane block on the nonoperative sideultrasound-guided transversus abdominis plane block with 20 ml mixture 0.20% ropivacaine + dexamethasone 5 mg and quadratus lumborum block with 30 ml mixture 0.20% ropivacaine + dexamethasone 5 mg |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) physical status I-II class
- Colorectal cancer patients
- 18 and 80 years old
- Elective laparoscopic colorectal surgery
Key exclusion criteria (11 listed)
- serious complications associated with other systems:
- severe cardiac insufficiency
- renal failure
- hepatic encephalopathy
- infection in the block injection area
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 |
|---|---|---|
| Retrolaminar block on the operative sideAfter the skin near the puncture site was disinfected, 2ml of 1% lidocaine was injected into the puncture site for local infiltration. The needle was inserted beneath the ultrasound probe using an in-plane orientation to contact the lamina of the T8-T11 vertebra. Then we retracted the tip of needle to the lamina about 1 mm and withdrew to make sure that there was no blood or cerebrospinal fluid. Then, 30-40 mL mixture was injected posterior to the lamina of T8-T11. | Procedure or surgery | TR group |
| Quadratus lumborum block on the operative sideIn our study, we applied a transmuscular approach to the QLB. After the patients were placed in the lateral position, the skin near the puncture site was disinfected, a low-frequency (3-5 MHz), curvilinear probe is used and is located vertical to the iliac crest at the posterior axillary line to find the Shamrock sign. After the local infiltration for puncture site, the 22-G needle is then inserted in plane and directed to the QL muscle. After the proper position of the needle tip between the psoas major muscle and the QL muscle is confirmed, 30 ml mixture is injected into the interfascial plane. | Procedure or surgery | TQ group |
| Transversus abdominis plane block on the nonoperative sideAfter placing the patients in the supine position, the skin was disinfected. A linear probe was placed in the transverse plane at the midaxillary line between the lower costal margin and iliac crest. When the external oblique, internal oblique, and transversus abdominis muscles were observed, 2ml of 1% lidocaine was injected into the puncture site for local infiltration.Then, a 22-gauge, 80-mm needle was advanced using an in-plane technique in an anteromedial to posterolateral direction toward the TAP (the fascial plane between the internal oblique and transversus abdominis muscles). After the correct position of the needle tip was verified, 20 ml mixture was injected into the TAP. The ultrasound showed that the local anesthetic separated the internal oblique and transversus abdominis muscles, confirming the success of the block. | Procedure or surgery | TQ group, TR group |
Primary outcome
the cumulative consumption of sufentanil
Time frame: 24 hours after nerves block
the outcome in micrograms
11 secondary outcomes
the patient's mean arterial pressure (MAP), HR at rest and during movement at 1, 2, 4, 6, 8, 12, 18, 24 after nerves block
Time frame: the time for completion of nerves block was time 0
cumulative sufentanil consumption at predetermined time intervals
Time frame: within 24 hour after nerves block
time until the earliest single patient-controlled analgesia (PCA) dose of sufentanil
Time frame: within 24 hour after nerves block
the number of PCA press
Time frame: within 24 hour after nerves block
time until the earliest rescue analgesia and antiemetic
Time frame: within 24 hour after nerves block
the total dose of rescue analgesia and antiemetic
Time frame: within 24 hour after nerves block
block-related complications
Time frame: within 24 hour after nerves block
other side events
Time frame: within 24 hour after nerves block
patient satisfaction with pain management
Time frame: at 24th hour after nerves block
the length of hospital stay
Time frame: up to 2 weeks
Visual Analog Score (VAS) for pain at rest and during movement at 1, 2, 4, 6, 8, 12, 18, 24 after nerves block
Time frame: the time for completion of nerves block was time 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Retrolaminar block on the operative side, Quadratus lumborum block on the operative side and Transversus abdominis plane block on the nonoperative side in people with Quadratus Lumborum Block and Analgesia, run by dong zhang.
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 4 inclusion and 11 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 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
the cumulative consumption of sufentanil (time frame: 24 hours after nerves block). 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 14 Jun 2022.