Pain Management After Transnasal Transsphenoidal Surgery for Pituitary Adenomas

Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04611685
• Other study ID #: ZS-2631
• Status: Recruiting
• Phase: N/A
• Start date: October 31, 2020
• Est. completion date: October 2021

Study information

• Verified date: November 2020
• Source: Peking Union Medical College Hospital
• Contact: Bing Xing, MD
• Phone: +861069152530
• Email: xingbingemail[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 202
• Est. completion date: October 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Pain
• Pituitary Adenoma
• Pituitary Diseases
• Pituitary Neoplasms
• Surgery

Intervention

Drug:
• NSAID
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.
• Tramadol
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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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. Review. — View 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. Review. — View 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. — View 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. — View 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. Epub 2016 Mar 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	during the first 3 postoperative days
Primary	The VAS scores of patients	visual analogue scale score that represents the patient's subjective pain perception	24 hours after the surgery
Secondary	The VAS scores of patients	visual analogue scale score that represents the patient's subjective pain perception	48 hours after the surgery
Secondary	The VAS scores of patients	visual analogue scale score that represents the patient's subjective pain perception	72 hours after the surgery
Secondary	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	during the first 3 postoperative days