Clinical trial NCT04611685: Pain Management After Transnasal Transsphenoidal Surgery for Pituitary Adenomas
Official title: Non-Steroidal Anti-inflammatory Drugs (NSAIDS) vs. Tramadol in Pain Management After Transnasal Transsphenoidal Surgery Among Patients With Pituitary Adenomas: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pituitary Adenoma
Surgery
Pain
Keywords: NSAIDs
Tramadol
Pituitary Adenoma
Pain Management
Transnasal Transsphenoidal surgery
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-11-02
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The VAS scores of patients
timeFrame: 24 hours after the surgery
Secondary outcomes:
measure: The VAS scores of patients
timeFrame: 48 hours after the surgery
measure: The VAS scores of patients
timeFrame: 72 hours after the surgery
measure: The dynamic trend of VAS scores of patients during the first 3 postoperative days
timeFrame: during the first 3 postoperative days
Other outcomes:
measure: The side effects of the drugs
timeFrame: during the first 3 postoperative days
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
state: Beijing
Study officials:
affiliation: Neurosurgery, Peking Union Medical College Hospital, Beijing, China
name: Bing Xing, MD
role: STUDY_CHAIR
affiliation: Neurosurgery, Peking Union Medical College Hospital, Beijing, China
name: Wei Lian, MD
role: STUDY_DIRECTOR
References:
citation: Titsworth WL, Abram J, Guin P, Herman MA, West J, Davis NW, Bushwitz J, Hurley RW, Seubert CN. A prospective time-series quality improvement trial of a standardized analgesia protocol to reduce postoperative pain among neurosurgery patients. J Neurosurg. 2016 Dec;125(6):1523-1532. doi: 10.3171/2015.10.JNS15698. Epub 2016 Mar 11.
citation: Quiney N, Cooper R, Stoneham M, Walters F. Pain after craniotomy. A time for reappraisal? Br J Neurosurg. 1996 Jun;10(3):295-9. doi: 10.1080/02688699650040179.
citation: Joshi GP, Ogunnaike BO. Consequences of inadequate postoperative pain relief and chronic persistent postoperative pain. Anesthesiol Clin North Am. 2005 Mar;23(1):21-36. doi: 10.1016/j.atc.2004.11.013.
citation: Shepherd DM, Jahnke H, White WL, Little AS. Randomized, double-blinded, placebo-controlled trial comparing two multimodal opioid-minimizing pain management regimens following transsphenoidal surgery. J Neurosurg. 2018 Feb;128(2):444-451. doi: 10.3171/2016.10.JNS161355. Epub 2017 Mar 3.
citation: Molitch ME. Diagnosis and Treatment of Pituitary Adenomas: A Review. JAMA. 2017 Feb 7;317(5):516-524. doi: 10.1001/jama.2016.19699.