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Management of Pain in Lumbar Arthrodesis (KETASONA)

Primary Purpose

Pain, Postoperative

Status

Recruiting

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

Ketamine

Dexamethasone

Physiologic saline

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female
Age> 18 years
ASA I-III.
Lumbar arthrodesis.
Patients who have signed the preoperative informed consent for participation in the study.

Exclusion Criteria:

Unstable coronary heart disease
Glaucoma
History of allergy to ketamine, dexamethasone, or morphic chloride
Dementia or inability to understand IC and study
Pluricomplicated diabetes mellitus difficult to control
Patients who have taken an experimental drug 30 days before the start of the study or who are included in any type of study of an experimental drug

Sites / Locations

Hospital Dr Josep TruetaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Ketamina bolus plus Dexamethasone bolus plus infusion ketamine

Ketamine bolus plus ketamine infusion

Dexametasone arm

Saline bolus

Arm Description

Ketamine bolus (0.5 mg / kg) + dexamethasone 0.1 mg / kg bolus + ketamine infusion (0.1 mg / kg / h) up to three hours after admission to the Post-Anesthesia Resuscitation Unit (URPA)

Ketamine bolus (0.5 mg / kg) + physiological serum bolus + ketamine infusion (0.1 mg / kg / h) up to three hours after admission to the URPA.

Saline bolus + dexamethasone bolus 0.1 mg / kg + saline infusion up to three hours after admission in URPA

Saline bolus + saline bolus + saline infusion up to three hours after admission to the URPA

Outcomes

Primary Outcome Measures

Efficacy of Morphic Chloride (PCA) to treat pain during the post-operative period. Consumption of morphics will be evaluated

Consumption of morphics

Secondary Outcome Measures

Incidence of postoperative nausea and vomiting (PONV).

Incidence of postoperative nausea and vomiting

Efficay of study treatment regarding pain at 3 postoperative months

Pain at 3 postoperative months assessed by EVA scale pain. This is a visual analogue scale regarding pain.It consists of a 10-centimeter horizontal line, at the ends of which are the extreme expressions of a symptom. In the left is the absence or less intensity and in the right the greater intensity. The patient is asked to mark on the line the point that indicates the intensity and measure it with a millimeter ruler. The intensity is expressed in centimeters or millimeters. The evaluation will be: 1.Mild pain if the patient scores pain less than 3. 2.Moderate pain if the evaluation is between 4 and 7. 3.Severe pain if the evaluation is equal to or greater than 8.

Adverse side effects:Hallucinations / Delirium.Sedation. Diplopia, Hyperglycemia Respiratory depression (Sat <90%)

Rate of patients that presented adverse events

Full Information

NCT ID

NCT04751175

First Posted

August 6, 2020

Last Updated

April 12, 2021

Sponsor

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

1. Study Identification

Unique Protocol Identification Number

NCT04751175

Brief Title

Management of Pain in Lumbar Arthrodesis

Acronym

KETASONA

Official Title

Ketamine and Dexametasone in the Management of Pain in Lumbar Arthrodesis

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Recruiting

Study Start Date

July 4, 2013 (Actual)

Primary Completion Date

July 31, 2025 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

KETAMINE AND DEXAMETASONE IN THE MANAGEMENT OF PAIN IN LUMBAR ARTHRODESISPhase IV prospective randomized controlled single-center clinical trial to determine the effect of intravenous ketamine and dexamethasone administration perioperatively in patients undergoing lumbar arthrodesis.

Detailed Description

The need to carry out this study is to evaluate the analgesic effects after the administration of ketamine and dexamethasone intravenously perioperatively in patients undergoing lumbar arthrodesis and, likewise, study the incidence of pain and protocolize perioperative analgesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Postoperative

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Single-center, controlled, prospective and randomized clinical trial, phase IV, to determine the effect of perioperative intravenous administration of ketamine and dexamethasone in patients undergoing lumbar arthrodesis

Masking

ParticipantInvestigator

Masking Description

To preserve the masking of the study, the randomization system has been carried out by the pharmacy service personnel using the EPIDAT 4.0 program and only the personnel responsible for the pharmacy will know the randomization tables and codes. The main investigator will have the emergency codes in case of need by contacting the pharmacy service

Allocation

Randomized

Enrollment

128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ketamina bolus plus Dexamethasone bolus plus infusion ketamine

Arm Type

Experimental

Arm Description

Ketamine bolus (0.5 mg / kg) + dexamethasone 0.1 mg / kg bolus + ketamine infusion (0.1 mg / kg / h) up to three hours after admission to the Post-Anesthesia Resuscitation Unit (URPA)

Arm Title

Ketamine bolus plus ketamine infusion

Arm Type

Experimental

Arm Description

Ketamine bolus (0.5 mg / kg) + physiological serum bolus + ketamine infusion (0.1 mg / kg / h) up to three hours after admission to the URPA.

Arm Title

Dexametasone arm

Arm Type

Active Comparator

Arm Description

Saline bolus + dexamethasone bolus 0.1 mg / kg + saline infusion up to three hours after admission in URPA

Arm Title

Saline bolus

Arm Type

Placebo Comparator

Arm Description

Saline bolus + saline bolus + saline infusion up to three hours after admission to the URPA

Intervention Type

Drug

Intervention Name(s)

Ketamine

Intervention Description

Ketamine, being a non-competitive antagonist of NMDA receptors, could represent a good option as an opioid treatment enhancer for acute postoperative pain and avoid chronic pain, by reducing the '' wind-up '' phenomenon of central sensitization

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

A meta-analysis published in September 2011 affirms that the administration of dexamethasone at a dose of 0.1 mg / kg is an effective complement to multimodal analgesia strategies to reduce postoperative pain and opioid consumption after surgery. Preoperative administration of the drug produces a more consistent analgesic effect than intraoperative administration

Intervention Type

Drug

Intervention Name(s)

Physiologic saline

Intervention Description

placebo

Primary Outcome Measure Information:

Title

Efficacy of Morphic Chloride (PCA) to treat pain during the post-operative period. Consumption of morphics will be evaluated

Description

Consumption of morphics

Time Frame

4 hours post operative

Secondary Outcome Measure Information:

Title

Incidence of postoperative nausea and vomiting (PONV).

Description

Incidence of postoperative nausea and vomiting

Time Frame

4 hours post operative

Title

Efficay of study treatment regarding pain at 3 postoperative months

Description

Time Frame

3 months

Title

Adverse side effects:Hallucinations / Delirium.Sedation. Diplopia, Hyperglycemia Respiratory depression (Sat <90%)

Description

Rate of patients that presented adverse events

Time Frame

4 hours post operative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female Age> 18 years ASA I-III. Lumbar arthrodesis. Patients who have signed the preoperative informed consent for participation in the study. Exclusion Criteria: Unstable coronary heart disease Glaucoma History of allergy to ketamine, dexamethasone, or morphic chloride Dementia or inability to understand IC and study Pluricomplicated diabetes mellitus difficult to control Patients who have taken an experimental drug 30 days before the start of the study or who are included in any type of study of an experimental drug

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Cristina Martinez, Sc

Phone

972940200

Ext

2343

cmartinez@idibgi.org

First Name & Middle Initial & Last Name or Official Title & Degree

Emili Leon, MD

Phone

972940200

emili_leon@yahoo.es

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Emili Leon, MD

Organizational Affiliation

Hospital Dr Josep Trueta and Hospital Santa Caterina

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Dr Josep Trueta

City

Girona

ZIP/Postal Code

17007

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cristina Martinez, MSc

Phone

972940200

Ext

2343

cmartinez@idibgi.org

First Name & Middle Initial & Last Name & Degree

Emili Leon, MD

First Name & Middle Initial & Last Name & Degree

Anna Bellod, MD

First Name & Middle Initial & Last Name & Degree

Noelia Rios, MD

12. IPD Sharing Statement

Learn more about this trial

Management of Pain in Lumbar Arthrodesis

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