Cancer Clinical Trial
Official title:
Analgesia for Laparotomy in Cancer Patients:Ultrasound-guided Quadratus Lumborum Block Versus Transversus Abdominis Plane Block
Verified date | October 2017 |
Source | Mansoura University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Regional anesthesia of the abdomen significantly reduce postoperative pain, spare the
systemic opioids and decrease postoperative nausea and vomiting. Multiple regional techniques
can be performed at the neuro-axis (epidural), the nerve root (paravertebral) and the
peripheral nerve (transversus abdominis plane).
Quadratus lumborum (QL) block is an addition into the league of truncal nerve block
techniques that has been found to provide analgesia for abdominal surgeries. Several case
reports have shown that local anesthetic injection around the quadratus lumborum muscle is
effective in providing pain relief after various abdominal operations and in patients with
chronic pain.
The study hypothesis is that quadratus lumborum block in single shot may be more superior to
transversus abdominus plane block as regard intra-operative and the post-operative analgesia.
Status | Completed |
Enrollment | 102 |
Est. completion date | July 15, 2017 |
Est. primary completion date | July 15, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Patients scheduled for open abdominal cancer surgery. - American Society of Anesthesiologists physical status grade I and grade II. Exclusion Criteria: 1. Patient refusal. 2. Neuromuscular diseases (as myopathies, myasthenia gravies, …...) 3. Hematological diseases, bleeding or coagulation abnormality. 4. Psychiatric diseases. 5. Local skin infection and sepsis at site of the block. 6. Known intolerance to the study drugs. 7. Body Mass Index > 40 Kg/m2. |
Country | Name | City | State |
---|---|---|---|
Egypt | Oncolgy Center, Mansoura University, | Mansourah | DK |
Lead Sponsor | Collaborator |
---|---|
Alaa Mazy |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The total dose of morphine consumption | milligram | postoperative: in the first 24-hour | |
Secondary | the time to the first analgesic requirement | hours | postoperative: in the first 24-hour | |
Secondary | pain intensity by visual analogue scale (VAS) | 0-10 point visual analogue scale. 0 is no pain, 10 the worst pain. | postoperatively, at 0, 2, 4, 8, 16 and 24 hours | |
Secondary | sedation score by Modified Ramsay sedation score | 1-6 scale, 1. Anxious, agitated, restless. 2. Awake, but tranquil and cooperative. 3. Responsive to commands only. 4. Brisk response to light glabellar tap or loud auditory stimulus. 5. Sluggish response to light glabellar tap or loud auditory stimulus. 6. No response to light glabellar tap or loud auditory stimulus. |
postoperative, at 0, 2, 4, 8, 16 and 24 hours | |
Secondary | postoperative nausea, vomiting | percent | postoperative in the first 24 hours | |
Secondary | Mean blood pressure | millimeter mercury | intraoperatively every 30 minutes, then at 0, 2, 4, 8,16 and 24 hours postoperatively. | |
Secondary | Heart rate | beat/minute | intraoperatively every 30 minutes, then at 0, 2, 4, 8,16 and 24 hours postoperatively. |
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