Analgesia Regimens Following Trans-sphenoidal Surgery for Pituitary Tumors

Pain Clinical Trial

Official title:

Randomized, Double-Blind, Placebo-Controlled Trial Comparing Opioid-Sparing and Opioid-Containing Analgesia Regimens Following Trans-sphenoidal Surgery for Pituitary Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02351700
• Other study ID #: 14BN090
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2015
• Est. completion date: April 1, 2016

Study information

• Verified date: November 2019
• Source: St. Joseph's Hospital and Medical Center, Phoenix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Post-operative pain control is a common concern patients have when they consider undergoing a surgical procedure. Although effective for treating acute pain, opioid analgesics are also associated with dose-dependent adverse effects, including constipation, nausea and vomiting, altered mental status, and respiratory depression, all of which have been shown to increase patient length of stay. The use of non-opioid analgesics with different mechanisms of actions for acute pain control via a multi-modal approach is efficacious in reducing opioid consumption, decreasing the incidence of adverse effects, improving patient satisfaction and recovery time, and decreasing hospital costs.Certain minimally invasive procedures may afford many patients the opportunity to achieve adequate post-operative pain control with minimal to no requirement of opioid analgesics, thereby sparing the patient known adverse effects that can increase length of stay and costs. The ENTS approach for resection of pituitary tumors is the standard surgical procedure for these lesions, and is associated with pain that is more easily managed post-operatively, making it an ideal procedure for an opioid-sparing post-operative pain regimen. Anecdotally, the investigators note that in the investigator's post-operative pituitary patient population that post-operative pain can frequently be adequately managed with scheduled non-opioid analgesics, often without requiring breakthrough opioid doses. Another safe and effective non-opioid analgesic that is widely used in multi-modal pain management for moderate pain is IV Caldolor (ibuprofen). After literature review, the investigators were unable to find a study that had attempted to use an opioid-sparing analgesic regimen for post-operative pain control following ENTS approach for resection of pituitary tumors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 1, 2016
• Est. primary completion date: March 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Pain
• Pituitary Diseases
• Pituitary Neoplasms
• Pituitary Tumor

Intervention

Drug:
• IV Caldolor
IV Caldolor (IV ibuprofen) intraoperatively and postoperatively
• IV Placebo
IV Placebo intraoperatively and postoperatively

Locations

Country	Name	City	State
United States	St. Joseph's Hospital and Medical Center	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph's Hospital and Medical Center, Phoenix

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — 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 — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Total Cost of Hospital Charges Compared Between Two Arms	Total hospital costs for patients in IV ibuprofen arm compared to IV placebo arm	until discharge from hospital, an expected stay of 2 days
Other	The Number of Participants Who Have a Bowel Movement During Hospitalization in Both Groups	patients with one or more bowel movement(s) in the first 48 hours after surgery	until discharge from hospital, an expected stay of 2 days
Other	Length of Stay in Hospital Compared Between Two Arms	Length of hospital stay from time of surgery to time of discharge.	until discharge from hospital, an expected stay of 2 days
Other	Total Number of Doses of Any Anti-emetic Required Post-operatively in Both Groups	Use of antiemetics in first 48 hours after surgery	until discharge from hospital, an expected stay of 2 days
Primary	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	Breakthrough Narcotic Requirement	Rescue narcotic in both groups will be recorded and compared using a standard equianalgesic oral morphine equivalent (OME) calculation	until discharge from hospital, an expected stay of 2 days
Secondary	Other Adverse Events	Epistaxis, potentially related to IV ibuprofen, will be compared between two groups	until discharge from hospital, an expected stay of 2 days