Phase 4
Completed N=62
Analgesia Regimens Following Trans-sphenoidal Surgery for Pituitary Tumors
Pituitary Tumor · Postoperative Pain
Source: ClinicalTrials.gov NCT02351700 ↗
Enrolled (actual)
62
Serious AEs
3.2%
Results posted
Oct 2021
Primary outcomePrimary: Comparison of Mean Pain Scores Between Two Arms (Measured Every 4 Hours Over 48 Hour) — 1.7; 2.8 0-10 units on a scale
◆ Published Evidence
Established
42citations · ~5 / year
Randomized, double-blinded, placebo-controlled trial comparing two multimodal opioid-minimizing pain management regimens following transsphenoidal surgery.
Summary
A randomized, double-blind, placebo-controlled intervention trial involving 100 treated subjects undergoing endonasal trans-sphenoidal (ENTS) resection of pituitary lesion. Subjects will be randomized into two groups: 50 treated in the opioid-sparing arm and 50 treated in the standard post-operative medication arm.
Linked Publications
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Randomized, double-blinded, placebo-controlled trial comparing two multimodal opioid-minimizing pain management regimens following transsphenoidal surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Mean Pain Scores Between Two Arms (Measured Every 4 Hours Over 48 Hour) |
1.7; 2.8 | — |
| SECONDARY Breakthrough Narcotic Requirement |
26.3; 62.5 | — |
| SECONDARY Other Adverse Events |
0; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patient undergoing ENTS surgery for resection of pituitary tumor.
- Adults >18 years and 19 and 2.0
- Allergy or intolerance to acetaminophen, ibuprofen, or opioids
- Pre-operative opioid tolerance, dependence, or abuse
- Anaphylaxis to opioids
- History of peptic ulcer disease or recent gastrointestinal bleed requiring surgery
- Cirrhosis, hepatitis, liver transplant, or liver function studies out of normal range, defined as aspartate aminotransferase (AST)/alanine aminotransferase (ALT)/bilirubin> 3x upper limit of normal range
- Subject unwilling or unable to sign informed consent for the study
- Pregnancy
- Incarcerated patients
Data sourced from ClinicalTrials.gov (NCT02351700) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.