Transversus Abdominis Plane Block Plus Quadratus Lumborum Block or Retrolaminar Block of Multiple Injections for Postoperative Analgesia Following Laparoscopic Colorectal Surgery
Primary Purpose
Quadratus Lumborum Block, Analgesia, Laparoscopic
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Retrolaminar block on the operative side
Quadratus lumborum block on the operative side
Transversus abdominis plane block on the nonoperative side
Sponsored by
About this trial
This is an interventional treatment trial for Quadratus Lumborum Block
Eligibility Criteria
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status I-II class
- Colorectal cancer patients
- 18 and 80 years old
- Elective laparoscopic colorectal surgery
Exclusion Criteria:
- serious complications associated with other systems:
- severe cardiac insufficiency
- renal failure
- hepatic encephalopathy
- infection in the block injection area
- coagulopathy
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
TR group
TQ group
Arm Description
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
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
Outcomes
Primary Outcome Measures
the cumulative consumption of sufentanil
the outcome in micrograms
Secondary Outcome Measures
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.
cumulative sufentanil consumption at predetermined time intervals
the outcome in minutes
time until the earliest single patient-controlled analgesia (PCA) dose of sufentanil
the outcome in minutes
the number of PCA press
the outcome in frequency
time until the earliest rescue analgesia and antiemetic
the outcome in minutes
the total dose of rescue analgesia and antiemetic
the outcome in milligrams
block-related complications
such as hematoma, infection, quadriceps weakness, pneumothorax, deep visceral injury, and evidence of systemic toxicity to the local anesthetic
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
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)
the length of hospital stay
the outcome in days
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05416866
Brief Title
Transversus Abdominis Plane Block Plus Quadratus Lumborum Block or Retrolaminar Block of Multiple Injections for Postoperative Analgesia Following Laparoscopic Colorectal Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 20, 2022 (Anticipated)
Primary Completion Date
November 20, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
dong zhang
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quadratus Lumborum Block, Analgesia, Laparoscopic, Colorectal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
A randomized, double-blind, controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Except the regional anesthesiologist who performed the blocks, patients, surgeons, theatre anesthesiologists, ward staff, caregivers, and the outcome assessor were unaware of group allocation. The regional anesthesiologist was not involved in the other parts of the study. All data was collected by personnel blinded to the patient group allocation.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TR group
Arm Type
Experimental
Arm Description
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
Arm Title
TQ group
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Retrolaminar block on the operative side
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Quadratus lumborum block on the operative side
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Transversus abdominis plane block on the nonoperative side
Intervention Description
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.
Primary Outcome Measure Information:
Title
the cumulative consumption of sufentanil
Description
the outcome in micrograms
Time Frame
24 hours after nerves block
Secondary Outcome Measure Information:
Title
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
Description
MAP in mmHg, HR in rate/one minute.
Time Frame
the time for completion of nerves block was time 0
Title
cumulative sufentanil consumption at predetermined time intervals
Description
the outcome in minutes
Time Frame
within 24 hour after nerves block
Title
time until the earliest single patient-controlled analgesia (PCA) dose of sufentanil
Description
the outcome in minutes
Time Frame
within 24 hour after nerves block
Title
the number of PCA press
Description
the outcome in frequency
Time Frame
within 24 hour after nerves block
Title
time until the earliest rescue analgesia and antiemetic
Description
the outcome in minutes
Time Frame
within 24 hour after nerves block
Title
the total dose of rescue analgesia and antiemetic
Description
the outcome in milligrams
Time Frame
within 24 hour after nerves block
Title
block-related complications
Description
such as hematoma, infection, quadriceps weakness, pneumothorax, deep visceral injury, and evidence of systemic toxicity to the local anesthetic
Time Frame
within 24 hour after nerves block
Title
other side events
Description
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
Time Frame
within 24 hour after nerves block
Title
patient satisfaction with pain management
Description
Patient satisfaction on postoperative analgesia using a 5-point scale (1 = very unsatisfied, 2 = unsatisfied, 3 = fair, 4 = satisfied, and 5 = very satisfied)
Time Frame
at 24th hour after nerves block
Title
the length of hospital stay
Description
the outcome in days
Time Frame
up to 2 weeks
Title
Visual Analog Score (VAS) for pain at rest and during movement at 1, 2, 4, 6, 8, 12, 18, 24 after nerves block
Description
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)
Time Frame
the time for completion of nerves block was time 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
American Society of Anesthesiologists (ASA) physical status I-II class
Colorectal cancer patients
18 and 80 years old
Elective laparoscopic colorectal surgery
Exclusion Criteria:
serious complications associated with other systems:
severe cardiac insufficiency
renal failure
hepatic encephalopathy
infection in the block injection area
coagulopathy
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
12. IPD Sharing Statement
Learn more about this trial
Transversus Abdominis Plane Block Plus Quadratus Lumborum Block or Retrolaminar Block of Multiple Injections for Postoperative Analgesia Following Laparoscopic Colorectal Surgery
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