NCT04611685

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
202

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

October 31, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

November 3, 2020

Status Verified

November 1, 2020

Enrollment Period

11 months

First QC Date

October 28, 2020

Last Update Submit

November 2, 2020

Conditions

Pituitary AdenomaSurgeryPain

Keywords

NSAIDsTramadolPituitary AdenomaPain ManagementTransnasal Transsphenoidal surgery

Outcome Measures

Primary Outcomes (1)

  • The VAS scores of patients

    visual analogue scale score that represents the patient's subjective pain perception

    24 hours after the surgery

Secondary Outcomes (3)

  • The VAS scores of patients

    48 hours after the surgery

  • The VAS scores of patients

    72 hours after the surgery

  • The dynamic trend of VAS scores of patients during the first 3 postoperative days

    during the first 3 postoperative days

Other Outcomes (1)

  • The side effects of the drugs

    during the first 3 postoperative days

Study Arms (2)

NSAIDs

EXPERIMENTAL

Parecoxib (iv.) for once \& Loxoprofen (po.) for routine use during the first 3 postop. days.

Drug: NSAID

Tramadol

ACTIVE COMPARATOR

Tramadol (im.) for once \& Tramcontin (po.) for routine use during the first 3 postop. days.

Drug: Tramadol

Interventions

NSAIDDRUG

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.)
NSAIDs
TramadolDRUG

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.)
Tramadol

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with pituitary adenomas that need transnasal transsphenoidal surgery
  • Patients of either gender aged 18 to 70 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (5)

  • 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.

    PMID: 26967774BACKGROUND

  • 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.

    PMID: 8799542BACKGROUND

  • 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.

    PMID: 15763409BACKGROUND

  • 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.

    PMID: 28298041BACKGROUND

  • Molitch ME. Diagnosis and Treatment of Pituitary Adenomas: A Review. JAMA. 2017 Feb 7;317(5):516-524. doi: 10.1001/jama.2016.19699.

    PMID: 28170483BACKGROUND

MeSH Terms

Conditions

Pituitary NeoplasmsPainAgnosia

Interventions

Anti-Inflammatory Agents, Non-SteroidalparecoxibloxoprofenTramadol

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHypothalamic NeoplasmsSupratentorial NeoplasmsBrain NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypothalamic DiseasesPituitary DiseasesEndocrine System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral Manifestations

Intervention Hierarchy (Ancestors)

Analgesics, Non-NarcoticAnalgesicsSensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnti-Inflammatory AgentsTherapeutic UsesAntirheumatic AgentsCyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipids

Study Officials

  • Bing Xing, MD

    Neurosurgery, Peking Union Medical College Hospital, Beijing, China

    STUDY CHAIR

  • Wei Lian, MD

    Neurosurgery, Peking Union Medical College Hospital, Beijing, China

    STUDY DIRECTOR

Central Study Contacts

Bing Xing, MD

CONTACT

+861069152530xingbingemail@aliyun.com

Xiaopeng Guo, MD

CONTACT

+8617701220936guoxiaopeng_pumch@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are assigned to one of two groups in parallel during the study, using the method of randomization. The ratio is 1:1.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2020

First Posted

November 2, 2020

Study Start

October 31, 2020

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

November 3, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

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.

Locations

CN(1)