An interventional study of NSAID and Tramadol in Pituitary Adenoma, Surgery and Pain, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-11-03.
Sponsored by Peking Union Medical College Hospital · Not applicable, Interventional, and Treatment
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.
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.
657 studies on the registry are indexed under Adenoma; 98 are open to participants now.
This study's planned enrollment of 202 is below the median of 250 across 412 interventional studies indexed under Adenoma.
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Exclusion Criteria:
Parecoxib (iv.) for once \& Loxoprofen (po.) for routine use during the first 3 postop. days.
Drug: NSAID
Tramadol (im.) for once \& Tramcontin (po.) for routine use during the first 3 postop. days.
Drug: Tramadol
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.
Also known as: Parecoxib (iv.), Loxoprofen (po.)
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.
Also known as: Tramadol (iv.), Tramcontin (po.)
The VAS scores of patients
visual analogue scale score that represents the patient's subjective pain perception
Time frame: 24 hours after the surgery
The VAS scores of patients
visual analogue scale score that represents the patient's subjective pain perception
Time frame: 48 hours after the surgery
The VAS scores of patients
visual analogue scale score that represents the patient's subjective pain perception
Time frame: 72 hours after the surgery
The dynamic trend of VAS scores of patients during the first 3 postoperative days
visual analogue scale score that represents the patient's subjective pain perception
Time frame: during the first 3 postoperative days
The side effects of the drugs
Including but not limited to nausea, vomiting, upset stomach, stomach pain, gastrorrhagia, dizziness and skin rash, while using these drugs
Time frame: during the first 3 postoperative days
Plan to share: No — The individual participant data can be made available upon reasonable request to the study chair, Dr. Bing Xing, or the study director, Dr. Wei Lian.
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Peking Union Medical College Hospital