Post Operative Pain, Acute
Conditions
Keywords
Visual Analogue Scale, Post Operative Pain, Dosage of analgesic, Cosmetic
Brief summary
The investigator conduct a randomized clinical trial for the needlescopic and conventional laparoscopic adrenalectomy to assess whether mini laparoscopic adrenalectomy is better than conventional laparoscopic adrenalectomy in terms of pain, complication rate , and wound cosmetics
Detailed description
If the participant with unilateral PA tumor less than 4cm is willing to enter the clinical trial, he/she will be randomly assigned to two groups (conventional vs needlescopic laparoscopic adrenalectomy) in a 1:1 ratio, followed by preoperative assessement. All procedures were performed by experienced laparoscopic urologists (number of complex laparoscopic procedures \> 50 cases/yr for 10 yrs). The participant were blinded to the type of surgical procedure underwent until the pain assessment was completed in the morning of the second days after surgery
Interventions
DEVICENeedlescopic laparoscopic adrenalectomy
Compared with traditional laparoscopic surgery using 5-12 mm instruments, the wound of needlescopic laparoscopic surgery is smaller. Postoperative pain and recovery are also better than traditional laparoscopic surgery.
DEVICEconventional laparoscopic adrenalectomy
conventional laparoscopic adrenalectomy
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Over the age of 20 years old. 2. Primary aldosteronism with unilateral adrenal lesions smaller than 4 cm 3. Indications for laparoscopic surgery. 4. Informed consent
Exclusion criteria
1. Over 80 years old 2. Suspected adrenal malignancy or pheochromocytoma 3. Other concurrent surgery 4. Patients who underwent bilateral adrenal tumor resection at the same time 5. History of peritonitis or having undergoing major ipsilateral abdominal surgery. 6. American Society of Anesthesiologists (ASA) Class III or IV (with severe cardiovascular disease, uncontrolled hypertension, diabetes, chronic pulmonary obstructive pulmonary disease, morbid obesity (BMI \> 40), dialysis patients, myocardial infarction, stroke, coronary artery disease, liver or coagulation dysfunction, etc.) 7. Opioid addiction 8. Patient have side effects from taking of acetaminophen, celecoxib or opioids 9. Acute intoxication of alcohol, sleep aids, anesthetics, centrally acting analgesics, opium or psychotropic drugs has occurred. 10. Patients using monoamine oxidase inhibitors (MAOIs) concurrently or within the past 14 days. 11. Patients with chronic pain or respiratory depression (such as chronic obstructive pulmonary disease) 12. Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Timing that two consecutive VAS less than 3 points | up to 1 month postoperatively | Timing that two consecutive VAS less than 3 points after operation * The nurse for pain assessement would not know the allocation of the patient to this trial arms * Wound pain was assessed on a visual analogue scale (VAS) from 0 (none) to 10 (worst) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative morphine dosing | Right after adrenalectomy until the morning of post-op Day 2 ( before the wound dressing change) | \>On the operative day: morphine (10mg/1mL/amp) 2mg IV Q4H PRN(every 4 hours.Pro re nata) was administered intravenously. \> Post-op Day 1: acetaminophen (500mg/tab) # 1 PO QID (quater in die) and celecoxib (200 mg/Cap) # 1 PO QD( quaque die), morphine (10mg/1mL/amp) 2mg IV Q4H PRN (every 4 hours.Pro re nata) as rescue analgesia (as VAS \>=3) |
Countries
Taiwan
Contacts
Primary ContactJeff Chueh, Director, Dep. of Urology, NTUH
Backup ContactChu-wen Fang
Outcome results
None listed