Comparison of Efficacy and Safety of the Postoperative Analgesia Methods

Supratentorial Neoplasms Clinical Trial

Official title:

Comparison of Efficacy and Safety of the Postoperative Analgesia Methods for Supratentorial Craniotomy by Integrated Pulmonary Index (IPI)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02929147
• Other study ID #: Istanbul U
• Status: Not yet recruiting
• Phase: Phase 4
• First received: October 6, 2016
• Last updated: October 10, 2016
• Start date: November 2016
• Est. completion date: November 2017

Study information

• Verified date: October 2016
• Source: Istanbul University
• Contact: Ozlem Korkmaz Dilmen, MD
• Phone: +902124143435
• Email: korkmazdilmen[@]gmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

An optimal analgesic therapy is very important for postoperative recovery. In recent years, several studies showed that the prevalence of the moderate to severe pain after craniotomy ranged from 69 to 87% of patients. In a previous study, the investigators showed that the use of morphine based patient controlled analgesia prevented moderate to severe postoperative pain in patients undergoing supratentorial craniotomy. Morphine related side effects such as sedation, miosis, respiratory depression, nausea and vomiting produce a general reluctance for their use in neurosurgery. Therefore, all patients were closely observed to detect opioid related side effects in the intensive care unit for 24 hours following surgery in the previous study. The Integrated Pulmonary Index (IPI) is a new tool that calculates respiratory and hemodynamic parameters noninvasively. In the present study the investigators will use different doses of morphine based PCA and the IPI system to determine more effective and safer morphine dose for postoperative analgesia following supratentorial craniotomy.

Description:

An optimal analgesic therapy is very important for postoperative recovery. In recent years, several studies showed that the prevalence of the moderate to severe pain after craniotomy ranged from 69 to 87% of patients. In a previous study, the investigators showed that the use of morphine based patient controlled analgesia prevented moderate to severe postoperative pain in patients undergoing supratentorial craniotomy. Morphine related side effects such as sedation, miosis, respiratory depression, nausea and vomiting produce a general reluctance for their use in neurosurgery. Therefore, all patients were closely observed to detect opioid related side effects in the intensive care unit for 24 hours following surgery in the previous study. The Integrated Pulmonary Index (IPI) is a new tool that calculates respiratory and hemodynamic parameters noninvasively. In the present study the investigators will use different doses of morphine based PCA and the IPI system to determine more effective and safer morphine dose for postoperative analgesia following supratentorial craniotomy.

90 patients will randomize in 3 groups following supratentorial craniotomy. All patients will previously instruct on the PCA pumps (Abbott Provider, Chicago, USA) and visual analogue scale (VAS) from 0 to 10, with 0 being no pain and 10 being the worst pain imaginable. All patients will use PCA for 24 hours following supratentorial craniotomy. In the Group 1 the PCA will set to administer a bolus dose of 1 mg morphine on demand with a lockout period of 10 minutes and maximum 20 mg for 4 hours. In the Group 2 the PCA set to administer a bolus dose of 0.5 mg morphine on demand with a lockout period of 10 minutes and maximum 20 mg for 4 hours. In the Group 3 the PCA will contain placebo. The Group 3 will take 50 mg dexketoprofen in the recovery room. Intra venous injections of dexketoprofen will repeat every 8 hours. If the VAS skore more than 4 the Group 3 patients will take 1 g paracetamol every 6 hours.

All patients will observe by the Integrated Pulmonary Index (IPI). It is a new device that provides to recognise in a patients respiratory status. This software tool is a single index value ranging from 1 to 10 based on 4 physiological parameters: end tidal carbon dioxide, respiratory rate, oxygen saturation, pulse rate. Patients will asses at 10th minute, 1, 2, 6, 12, and 24 hours postoperatively. Sedation will evaluate according to Ramsay score. VAS scores, total morphine consumption, Ramsay score, blood pressure, heart rate and respiratory rate, the IPI score will record at each time pain will evaluate. Postoperative side effects, including rash, pruritus, nausea and vomiting will record at the same intervals and defined by a scale with 0 = absent or 1 = present. Moreover the lowest IPI score, the apnea count (longer than 30 seconds) and the count of the desaturation events will record in the postoperative 24 hours.

The 3 Groups will compare with respect to VAS scores, morphine consumption, IPI scores, the apnea count, the desaturation events and morphine related side effects during the 24 hours following supratentorial craniotomy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Diagnosis of supratentorial neoplasms

Exclusion Criteria:

• Neurological disorders hindering the communication, aphasia, Glasgow Coma Score (GCS) less than 15, drug or alcohol addiction, chronic pain, raised intracranial pressure, allergies to any of the drugs used in this study, hepatic or renal dysfunction, peptic ulcer disease, dementia.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Supratentorial Neoplasms

Intervention

Drug:
• Morphine
In the Group 1 the PCA will set to administer a bolus dose of 1 mg morphine on demand with a lockout period of 10 minutes and maximum 20 mg for 4 hours. In the Group 2 the PCA set to administer a bolus dose of 0.5 mg morphine on demand with a lockout period of 10 minutes and maximum 20 mg for 4 hours.
• Dexketoprofen
The Group 3 will take 50 mg dexketoprofen in the recovery room. Intra venous injections of dexketoprofen will repeat every 8 hours.
• Placebo
In the Group 3 the PCA will contain placebo.

Locations

Country	Name	City	State
Turkey	Ozlem Korkmaz Dilmen	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Dilmen OK, Akcil EF, Tunali Y, Karabulut ES, Bahar M, Altindas F, Vehid H, Yentur E. Postoperative analgesia for supratentorial craniotomy. Clin Neurol Neurosurg. 2016 Jul;146:90-5. doi: 10.1016/j.clineuro.2016.04.026. Epub 2016 May 4. — View Citation

Garah J, Adiv OE, Rosen I, Shaoul R. The value of Integrated Pulmonary Index (IPI) monitoring during endoscopies in children. J Clin Monit Comput. 2015 Dec;29(6):773-8. doi: 10.1007/s10877-015-9665-z. Epub 2015 Feb 11. — View Citation

Gottschalk A, Berkow LC, Stevens RD, Mirski M, Thompson RE, White ED, Weingart JD, Long DM, Yaster M. Prospective evaluation of pain and analgesic use following major elective intracranial surgery. J Neurosurg. 2007 Feb;106(2):210-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Integrated Pulmonary Index (IPI)		Change from Beseline IPI values in postoperative first 24 hours.(at 10th minute, 1, 2, 6, 12, and 24 hours post dose)	Yes
Secondary	Pain intensity measured by Visual Analog Score		Change from Beseline Pain Intensity in postoperative first 24 hours(at 10th minute, 1, 2, 6, 12, and 24 hours post dose)	Yes
Secondary	Sedation level measured by Ramsay score		Change from Beseline Sedation Level in postoperative first 24 hours(at 10th minute, 1, 2, 6, 12, and 24 hours post dose)	Yes
Secondary	Cumulative Morphine consumption		Change from Baseline in 1postoperative first 24 hours(at 10th minute, 1, 2, 6, 12, and 24 hours post dose)	Yes