The Pre-Emptive Administration Of Ketamine for Controlling Post-thoracotomy Pain

NCT03415191 | Completed

• 1 other identifier: 513/12
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this paper is to evaluate whether the pre-emptive administration of Ketamine would potentiate the effect of intravenous morphine analgesia in management of post thoracotomy pain. This was a single center, double-blind, placebo controlled, parallel-group, prospective study. Patients were randomly assigned to receive 1 mg/kg ketamine (Ketamine Group) or an equivalent dose of normal saline (Placebo Group) before thoracotomy in 1:1 ratio. All patients received postoperatively intravenous morphine administration as additional analgesic regimen Primary end-point was pain relief measured with Visual Analogue Scale at rest. The secondary end-points were the reduction of inflammatory response expressed by plasma c-reactive protein levels, the morphine consumption, and the rate of side effects. The measurements were carried out 6; 12; 24; 36; and 48 post operative hours.

Conditions

Post Thoracotomy Pain

Keywords

ketamine, post-thoracotomy pain, analgesia

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Pain Scores on the Visual Analog Scale at 48 hours

  The primary end-point was to evaluate whether ketamine was able to reduce the postoperative pain at the first 48 post-operative hours, compared to placebo. The pain levels were scored using a Visual Analogue scale (VAS) ranging from 0=absence of pain to 10= maximal level of pain.

  6 hours, 12 hours, 24 hours, 36 hours, and 48 hours after suregry

Secondary Outcomes (3)

• Change From Baseline in c-Reactive Protein (CRP) serum levels at 48 hours

  6 hours, 12 hours, 24 hours, 36 hours, and 48 hours following surgery.

• Change From Baseline in morphine consumption at 48 hours

  6 hours, 12 hours, 24 hours, 36 hours, and 48 hours of postoperative course.

• Indicence of clinical adverse effect in the entire post operative course

  entire post-operative course

Study Arms (2)

Ketamine Group

EXPERIMENTAL

Five minutes before thoracotomy incision, Ketamine Group received a bolus dose of ketamine 1 mg/kg intravenously

Drug: Ketamine

Placebo Group

PLACEBO COMPARATOR

Five minutes before thoracotomy incision, Placebo Group received a bolus dose of normal saline 1 mg/kg intravenously

Drug: Normal Saline

Interventions

Ketamine DRUG

A bolus dose of ketamine 1 mg/kg intravenously five minutes before surgical incision

Ketamine Group

Normal Saline DRUG

A bolus dose of normal saline 1 mg/kg intravenously five minutes before surgical incision

Placebo Group

Eligibility Criteria

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

You may qualify if:

• aged more than 18 years old,
• planned for an elective partial pneumonectomy (partial or total lobectomy involving one or more lobes, except total pneumonectomy)
• standard lateral thoracotomy for management of non small cell lung cancer (NSCLC)

You may not qualify if:

• allergy to Ketamine
• ASA score more than 3
• previous thoracic surgical procedures or lung resection
• mental disease
• participation to other studies
• lack of written informed consent.

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

Alfonso Fiorelli

Naples, 84100, Italy

Location

Related Publications (11)

• Romero A, Garcia JE, Joshi GP. The state of the art in preventing postthoracotomy pain. Semin Thorac Cardiovasc Surg. 2013 Summer;25(2):116-24. doi: 10.1053/j.semtcvs.2013.04.002.

  PMID: 24216528 BACKGROUND

• Fiorelli A, Vicidomini G, Laperuta P, Busiello L, Perrone A, Napolitano F, Messina G, Santini M. Pre-emptive local analgesia in video-assisted thoracic surgery sympathectomy. Eur J Cardiothorac Surg. 2010 Mar;37(3):588-93. doi: 10.1016/j.ejcts.2009.07.040. Epub 2009 Sep 12.

  PMID: 19748277 BACKGROUND

• Burton AW, Lee DH, Saab C, Chung JM. Preemptive intrathecal ketamine injection produces a long-lasting decrease in neuropathic pain behaviors in a rat model. Reg Anesth Pain Med. 1999 May-Jun;24(3):208-13. doi: 10.1016/s1098-7339(99)90129-3.

  PMID: 10338169 BACKGROUND

• Lee IO, Lee IH. Systemic, but not intrathecal, ketamine produces preemptive analgesia in the rat formalin model. Acta Anaesthesiol Sin. 2001 Sep;39(3):123-7.

  PMID: 11688102 BACKGROUND

• Mathews TJ, Churchhouse AM, Housden T, Dunning J. Does adding ketamine to morphine patient-controlled analgesia safely improve post-thoracotomy pain? Interact Cardiovasc Thorac Surg. 2012 Feb;14(2):194-9. doi: 10.1093/icvts/ivr081. Epub 2011 Nov 28.

  PMID: 22159259 BACKGROUND

• Joseph C, Gaillat F, Duponq R, Lieven R, Baumstarck K, Thomas P, Penot-Ragon C, Kerbaul F. Is there any benefit to adding intravenous ketamine to patient-controlled epidural analgesia after thoracic surgery? A randomized double-blind study. Eur J Cardiothorac Surg. 2012 Oct;42(4):e58-65. doi: 10.1093/ejcts/ezs398. Epub 2012 Jul 12.

  PMID: 22790008 BACKGROUND

• Tena B, Gomar C, Rios J. Perioperative epidural or intravenous ketamine does not improve the effectiveness of thoracic epidural analgesia for acute and chronic pain after thoracotomy. Clin J Pain. 2014 Jun;30(6):490-500. doi: 10.1097/AJP.0000000000000005.

  PMID: 24281290 BACKGROUND

• D'Alonzo RC, Bennett-Guerrero E, Podgoreanu M, D'Amico TA, Harpole DH, Shaw AD. A randomized, double blind, placebo controlled clinical trial of the preoperative use of ketamine for reducing inflammation and pain after thoracic surgery. J Anesth. 2011 Oct;25(5):672-8. doi: 10.1007/s00540-011-1206-4. Epub 2011 Aug 2.

  PMID: 21809148 BACKGROUND

• Yazigi A, Abou-Zeid H, Srouji T, Madi-Jebara S, Haddad F, Jabbour K. The effect of low-dose intravenous ketamine on continuous intercostal analgesia following thoracotomy. Ann Card Anaesth. 2012 Jan-Mar;15(1):32-8. doi: 10.4103/0971-9784.91479.

  PMID: 22234019 BACKGROUND

• Suzuki M, Haraguti S, Sugimoto K, Kikutani T, Shimada Y, Sakamoto A. Low-dose intravenous ketamine potentiates epidural analgesia after thoracotomy. Anesthesiology. 2006 Jul;105(1):111-9. doi: 10.1097/00000542-200607000-00020.

  PMID: 16810002 BACKGROUND

• Feltracco P, Barbieri S, Rizzi S, Ori C, Groppa F, De Rosa G, Frigo AC, Padrini R. Brief report: perioperative analgesic efficacy and plasma concentrations of S+ -ketamine in continuous epidural infusion during thoracic surgery. Anesth Analg. 2013 Jun;116(6):1371-5. doi: 10.1213/ANE.0b013e31828cbaf0. Epub 2013 Apr 4.

  PMID: 23558843 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Ketamine; Saline Solution

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Alfonso Fiorelli, MD, PhD

  University of Campania Luigi Vanvitelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This was a single center, double-blind, placebo controlled, parallel-group, prospective study. Patients were randomly assigned to Ketamine or Placebo group in 1:1 ratio and no changes to methods after trial commencement as type of randomization or eligibility criteria were attended.

Study Record Dates

• First Submitted: January 15, 2018
• First Posted: January 30, 2018
• Study Start: January 5, 2012
• Primary Completion: December 21, 2014
• Study Completion: February 1, 2015
• Last Updated: January 30, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)