Pain, Pituitary Adenoma, Surgery
Conditions
Keywords
NSAIDs, Tramadol, Pituitary Adenoma, Pain Management, Transnasal Transsphenoidal surgery
Brief summary
We hypothesize that the effects of non-steroidal anti-inflammatory drugs (NSAIDS) for pain relief among patients with pituitary adenomas undergoing transnasal transsphenoidal surgeries are non-inferior to tramadol. We aim to launch a single-center randomized clinical trial to verify this hypothesis.
Detailed description
Postoperative pain is an important clinical concern and quality-of-care metric, yet it is undertreated in neurosurgical patients. Approximately 40% of inpatients complain of severe pain postoperatively, and only 56% of these patients indicate that their pain is well controlled. In addition, pain is a common cause of delayed discharge and unplanned hospital readmission. Pituitary adenoma is the second most common benign primary central nervous system tumor, and transnasal transsphenoidal (TTS) has long taken over craniotomy to be the first-line surgical approach for pituitary tumor resection. TTS significantly reduces patient's surgical trauma, shortens the operation time, reduces surgery-related complications, and increases total tumor resection rate compared with the previously used craniotomy. However, given that the nasal mucosa is extremely sensitive, the feeling of pain is more obvious after surgery via TTS approach than via craniotomy. Opioids such as morphine and pethidine are the most effective post-surgical analgesics, but they have a series of side effects, such as drug addiction, decreased gastrointestinal motility, nausea and vomiting. Opioids are not an analgesic that must be used after TTS surgery. NSAIDS, such as parecoxib and lexone, and tramadol are also commonly used analgesics after surgery, and they are also effective. NSAIDS is a first-tier painkiller, and tramadol is a second-tier drug. There is no evidence-based evidence recommending the preferred choice of these two drugs. Which of NSAIDS and tramadol has the better analgesic effect and which drug brings lower side effects to patients is still unclear. The clinical application of the two drugs is entirely based on the personal habits of the surgeon. Therefore, we plan to conduct a prospective randomized controlled trial to explore: whether the analgesic effect of NSAIDS is non-inferior than tramadol; and whether the side effects of NSAIDS are not higher than tramadol. This result will guide us in clinical pain management for patients with pituitary adenomas after surgery via TTS approach.
Interventions
DRUGNSAID
Immediately after the operation, the patient is given (parecoxib 40 mg + sodium chloride 100 ml) intravenously once, and then given (loxoprofen 60 mg) orally twice a day during the first three postoperative days.
DRUGTramadol
Immediately after the operation, the patient is given (tramadol 100 mg) intramuscularly once, and then given (tramcontin 100 mg) orally twice a day during the first three postoperative days.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The participant, investigator and outcome assessors are all prevented from having knowledge of the interventions assigned to individual participants. Only the care provider knows individual specified intervention.
Intervention model description
Participants are assigned to one of two groups in parallel during the study, using the method of randomization. The ratio is 1:1.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients with pituitary adenomas that need transnasal transsphenoidal surgery * Patients of either gender aged 18 to 70 years
Exclusion criteria
* Patients with rhinitis, sinusitis, deviated nasal septum, etc. that can cause nasal pain * Patients with medical history of digestive ulcer/gastrointestinal bleeding * Patients with heart disease, severe liver and kidney dysfunction * Pregnant patients * Patients allergic to NSAIDs or tramadol * Patients who need long-term treatment of NSAIDs or analgesic for other reasons * Patients whose postoperative paraffin pathology suggests non-pituitary adenoma * Patients who have not undergone transsphenoidal surgery * Patients who reject to enter the group or ask to leave the group after entry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The VAS scores of patients | 24 hours after the surgery | visual analogue scale score that represents the patient's subjective pain perception |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The VAS scores of patients | 48 hours after the surgery | visual analogue scale score that represents the patient's subjective pain perception |
| The dynamic trend of VAS scores of patients during the first 3 postoperative days | during the first 3 postoperative days | visual analogue scale score that represents the patient's subjective pain perception |
Other
| Measure | Time frame | Description |
|---|---|---|
| The side effects of the drugs | during the first 3 postoperative days | Including but not limited to nausea, vomiting, upset stomach, stomach pain, gastrorrhagia, dizziness and skin rash, while using these drugs |
Countries
China
Contacts
Primary ContactBing Xing, MD
Backup ContactXiaopeng Guo, MD
Outcome results
None listed