Analgesia Regimens Following Trans-sphenoidal Surgery for Pituitary Tumors

NCT02351700 | Completed Phase 4 Results DMC

• 1 other identifier: 14BN090
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pituitary Tumor; Pain

Outcome Measures

Primary Outcomes (1)

• Comparison of Mean Pain Scores Between Two Arms (Measured Every 4 Hours Over 48 Hour)

  Comparison of pain scores between two arms using Visual Analog Scale (VAS) for Pain. Units of measure are 0=No Pain, 1=Annoying, 2=Mild Pain, 3=Troublesome, 4=Nagging Pain, Uncomfortable, 5=Distressing, 6=Miserable, 7=Horrible, 8=Intense, Dreadful, 9=Unbearable, 10=Worst Possible Pain. Higher values represent a worse outcome. There are no subscales.

  mean pain score over 48 hours

Secondary Outcomes (2)

• Breakthrough Narcotic Requirement

  until discharge from hospital, an expected stay of 2 days

• Other Adverse Events

  until discharge from hospital, an expected stay of 2 days

Other Outcomes (4)

• Total Cost of Hospital Charges Compared Between Two Arms

  until discharge from hospital, an expected stay of 2 days

• The Number of Participants Who Have a Bowel Movement During Hospitalization in Both Groups

  until discharge from hospital, an expected stay of 2 days

• Length of Stay in Hospital Compared Between Two Arms

  until discharge from hospital, an expected stay of 2 days

Study Arms (2)

IV Caldolor (ibuprofen)

ACTIVE COMPARATOR

Intravenous (IV) Caldolor (ibuprofen) (800mg every 8 hours) initiated during surgery and oral acetaminophen 1000mg every 6 hours initiated post-operatively and continued for the duration of the hospital stay (an expected average stay of 2 days) or 48 hours, whichever comes first. Breakthrough pain will be treated with rescue narcotics (IV morphine 2-4mg every 2 hours and oral oxycodone 5-15mg every 4 hours immediately post-operatively through discharge, an expected average stay of 2 days). Hydromorphone (IV 0.5-2mg every 2 hours and oral 2-4mg every 4 hours) will be used in patients with morphine or oxycodone allergy or intolerance.

Drug: IV Caldolor

standard treatment group

PLACEBO COMPARATOR

IV placebo will be initiated during surgery and oral acetaminophen 1000mg every 6 hours will be initiated post-operatively and continued for the duration of the hospital stay (an expected average stay of 2 days) or 48 hours, whichever comes first. Breakthrough pain will be treated with rescue narcotics (IV morphine 2-4mg every 2 hours and oral oxycodone 5-15mg every 4 hours immediately post-operatively through discharge, an expected average stay of 2 days). Hydromorphone (IV 0.5-2mg every 2 hours and oral 2-4mg every 4 hours) will be used in patients with morphine or oxycodone allergy or intolerance.

Drug: IV Placebo

Interventions

IV Caldolor DRUG

IV Caldolor (IV ibuprofen) intraoperatively and postoperatively

Also known as: IV ibuprofen, Opioid Sparing group

IV Caldolor (ibuprofen)

IV Placebo DRUG

IV Placebo intraoperatively and postoperatively

Also known as: Standard treatment group

standard treatment group

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient undergoing ENTS surgery for resection of pituitary tumor.
• Adults \>18 years and \<80 years of age.
• English speaking and literate or able to understand the use of a pain scale.
• Body Mass Index \>19 and \<40 kg/m2

You may not qualify if:

• Renal failure (acute or chronic) or creatinine \>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

Sponsors & Collaborators

• St. Joseph's Hospital and Medical Center, Phoenix: lead

Study Sites (1)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

Related Publications (10)

• Pizzi LT, Toner R, Foley K, Thomson E, Chow W, Kim M, Couto J, Royo M, Viscusi E. Relationship between potential opioid-related adverse effects and hospital length of stay in patients receiving opioids after orthopedic surgery. Pharmacotherapy. 2012 Jun;32(6):502-14. doi: 10.1002/j.1875-9114.2012.01101.x. Epub 2012 May 8.

  PMID: 22570188 BACKGROUND

• Husted H. Fast-track hip and knee arthroplasty: clinical and organizational aspects. Acta Orthop Suppl. 2012 Oct;83(346):1-39. doi: 10.3109/17453674.2012.700593.

  PMID: 23205862 BACKGROUND

• Costantini R, Affaitati G, Fabrizio A, Giamberardino MA. Controlling pain in the post-operative setting. Int J Clin Pharmacol Ther. 2011 Feb;49(2):116-27. doi: 10.5414/cp201401.

  PMID: 21255528 BACKGROUND

• Badie B, Nguyen P, Preston JK. Endoscopic-guided direct endonasal approach for pituitary surgery. Surg Neurol. 2000 Feb;53(2):168-72; discussion 172-3. doi: 10.1016/s0090-3019(99)00195-0.

  PMID: 10713196 BACKGROUND

• Dahl V, Dybvik T, Steen T, Aune AK, Rosenlund EK, Raeder JC. Ibuprofen vs. acetaminophen vs. ibuprofen and acetaminophen after arthroscopically assisted anterior cruciate ligament reconstruction. Eur J Anaesthesiol. 2004 Jun;21(6):471-5. doi: 10.1017/s026502150400609x.

  PMID: 15248627 BACKGROUND

• Southworth S, Peters J, Rock A, Pavliv L. A multicenter, randomized, double-blind, placebo-controlled trial of intravenous ibuprofen 400 and 800 mg every 6 hours in the management of postoperative pain. Clin Ther. 2009 Sep;31(9):1922-35. doi: 10.1016/j.clinthera.2009.08.026.

  PMID: 19843482 BACKGROUND

• Singla N, Rock A, Pavliv L. A multi-center, randomized, double-blind placebo-controlled trial of intravenous-ibuprofen (IV-ibuprofen) for treatment of pain in post-operative orthopedic adult patients. Pain Med. 2010 Aug;11(8):1284-93. doi: 10.1111/j.1526-4637.2010.00896.x. Epub 2010 Jun 30.

  PMID: 20609131 BACKGROUND

• Kroll PB, Meadows L, Rock A, Pavliv L. A multicenter, randomized, double-blind, placebo-controlled trial of intravenous ibuprofen (i.v.-ibuprofen) in the management of postoperative pain following abdominal hysterectomy. Pain Pract. 2011 Jan-Feb;11(1):23-32. doi: 10.1111/j.1533-2500.2010.00402.x.

  PMID: 20642488 BACKGROUND

• Chung KC, Barlev A, Braun AH, Qian Y, Zagari M. Assessing analgesic use in patients with advanced cancer: development of a new scale--the Analgesic Quantification Algorithm. Pain Med. 2014 Feb;15(2):225-32. doi: 10.1111/pme.12299. Epub 2014 Jan 8.

  PMID: 24400921 BACKGROUND

• 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: 28298041 RESULT

MeSH Terms

Conditions

Pituitary Neoplasms; Pain

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Limitations and Caveats

Groups were not balanced re:patient age, so pain scores were analyzed, including age as a covariate, to account for this difference. A second limitation is that analysis was not powered to detect rare bleeding complications or sellar hematoma.

Results Point of Contact

• Title: Andrew S. Little, MD
• Organization: Department of Neurosurgery, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center

neuropub@dignityhealth.org

602-406-3181

Study Officials

• Andrew S Little, MD

  Barrow Neurosurgical Associates physician with SJHMC privileges

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2015
• First Posted: January 30, 2015
• Study Start: February 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2016
• Last Updated: October 21, 2021
• Results First Posted: October 21, 2021

Record last verified: 2019-11

Locations

US (1)