Pain Management After Transnasal Transsphenoidal Surgery for Pituitary Adenomas

November 2, 2020 updated by: Peking Union Medical College Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

202

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NSAIDs
Parecoxib (iv.) for once & Loxoprofen (po.) for routine use during the first 3 postop. days.
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.
Other Names:
  • Parecoxib (iv.)
  • Loxoprofen (po.)
Active Comparator: Tramadol
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 (tramadol 100 mg) intramuscularly once, and then given (tramcontin 100 mg) orally twice a day during the first three postoperative days.
Other Names:
  • Tramadol (iv.)
  • Tramcontin (po.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The VAS scores of patients
Time Frame: 24 hours after the surgery
visual analogue scale score that represents the patient's subjective pain perception
24 hours after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The VAS scores of patients
Time Frame: 48 hours after the surgery
visual analogue scale score that represents the patient's subjective pain perception
48 hours after the surgery
The VAS scores of patients
Time Frame: 72 hours after the surgery
visual analogue scale score that represents the patient's subjective pain perception
72 hours after the surgery
The dynamic trend of VAS scores of patients during the first 3 postoperative days
Time Frame: during the first 3 postoperative days
visual analogue scale score that represents the patient's subjective pain perception
during the first 3 postoperative days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The side effects of the drugs
Time Frame: 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
during the first 3 postoperative days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Study Chair: Bing Xing, MD, Neurosurgery, Peking Union Medical College Hospital, Beijing, China
  • Study Director: Wei Lian, MD, Neurosurgery, Peking Union Medical College Hospital, Beijing, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2020

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

October 28, 2020

First Submitted That Met QC Criteria

October 28, 2020

First Posted (Actual)

November 2, 2020

Study Record Updates

Last Update Posted (Actual)

November 3, 2020

Last Update Submitted That Met QC Criteria

November 2, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZS-2631

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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