Analgesia Clinical Trial
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
Verified date | June 2022 |
Source | Gansu Provincial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | December 30, 2022 |
Est. primary completion date | November 20, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
dong zhang |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the cumulative consumption of sufentanil | the outcome in micrograms | 24 hours after nerves block | |
Secondary | 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. | the time for completion of nerves block was time 0 | |
Secondary | cumulative sufentanil consumption at predetermined time intervals | the outcome in minutes | within 24 hour after nerves block | |
Secondary | time until the earliest single patient-controlled analgesia (PCA) dose of sufentanil | the outcome in minutes | within 24 hour after nerves block | |
Secondary | the number of PCA press | the outcome in frequency | within 24 hour after nerves block | |
Secondary | time until the earliest rescue analgesia and antiemetic | the outcome in minutes | within 24 hour after nerves block | |
Secondary | the total dose of rescue analgesia and antiemetic | the outcome in milligrams | within 24 hour after nerves block | |
Secondary | block-related complications | such as hematoma, infection, quadriceps weakness, pneumothorax, deep visceral injury, and evidence of systemic toxicity to the local anesthetic | within 24 hour after nerves block | |
Secondary | 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 | within 24 hour after nerves block | |
Secondary | 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) | at 24th hour after nerves block | |
Secondary | the length of hospital stay | the outcome in days | up to 2 weeks | |
Secondary | 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) | the time for completion of nerves block was time 0 |
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