A Comparison Study Between Ketamine Versus Tramadol for Pain Management After Major Upper Abdominal Surgery

NCT02499341 | Completed

• 1 other identifier: 637
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is the comparison between ketamine and tramadol, regarding the analgesia quality and efficiency, in patients receiving Patient Controlled Analgesia (PCA) morphine, after major upper abdominal surgeries such as hepatectomies, gastrectomies, Whipple procedures and peripheral pancreatectomies. The goal is to bring out an improved analgesia scheme, which can be applied to the clinical work and refine the analgesia provided for major procedures which require increased postoperative opioids doses. In the study, half of patients will receive continuous intravenous infusion of tramadol and Patient Controlled Analgesia morphine and the other half will receive continuous intravenous infusion of ketamine and Patient Controlled Analgesia morphine postoperatively after major upper abdominal surgery. The successful combination of different drugs targets at the improvement of the analgesia provided, the reduction of complications and the exploitation of the pharmacodynamic properties of each drug.

Conditions

Postoperative Pain

Keywords

Tramadol; Ketamine; Morphine

Outcome Measures

Primary Outcomes (1)

• Measurement of morphine consumption expressed as milligrams postoperatively in abdominal surgery.

  48 hours postoperatively

Study Arms (2)

Tramadol

ACTIVE COMPARATOR

Intraoperative administration of a bolus dose of tramadol and continuous intravenous infusion of tramadol for up to 48 h postoperatively.

Drug: Tramadol

Ketamine

ACTIVE COMPARATOR

Intraoperative administration of a bolus dose of ketamine and continuous intravenous infusion of ketamine for up to 48 h postoperatively.

Drug: Ketamine

Interventions

Tramadol DRUG

Tramadol administered intravenously (1mg/kg) thirty minutes before the expected end of surgery, followed by a continuous infusion of tramadol (0.2mg•kg-¹•h-¹) for up to 48 h after major upper abdominal surgery, in patients receiving PCA morphine postoperatively at a bolus dose of 1 mg with a lockout period of 8 minutes.

Also known as: Tramal

Tramadol

Ketamine DRUG

Ketamine administered intravenously (0.5mg/kg) thirty minutes before the expected end of surgery, followed by a continuous infusion of ketamine (0.12mg•kg-¹•h-¹) for up to 48 h after major upper abdominal surgery, in patients receiving PCA morphine postoperatively at a bolus dose of 1 mg with a lockout period of 8 minutes.

Also known as: Ketalar

Ketamine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 70 years
• American Society of Anesthesiologists (ASA) physical status I and II
• Major Upper abdominal Surgery (Elective Hepatectomy, Gastrectomy, Whipple procedure, Peripheral Pancreatectomy)

You may not qualify if:

• Patient's refusal to participate in the study
• Performance of regional anaesthesia
• Unsuitability for Patient Controlled Analgesia
• Current opiates use
• Drug addiction
• Chronic Pain Syndromes
• Alcohol addiction
• Epilepsy
• Psychiatric disorders
• Use of Monoamine Oxidase Inhibitor or Selective Serotonin Reuptake Inhibitor
• Sleep Apnea Syndrome
• Extrapyramidal Syndromes
• Severe liver, kidney or heart disease
• Known allergy to ketamine, tramadol or morphine.

Sponsors & Collaborators

• Attikon Hospital: lead

Study Sites (1)

2nd Department of Anesthesiology, Attikon University Hospital

Athens, Attica, 12462, Greece

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Tramadol; Ketamine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Paraskevi Matsota, MD, PhD

  Attikon University Hospital, Athens, Greece

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, MD, PhD

Study Record Dates

• First Submitted: July 12, 2015
• First Posted: July 16, 2015
• Study Start: July 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 16, 2015

Record last verified: 2015-06

Locations

GR (1)