Comparing Three Different Doses of Intrathecal Ketamine

Analgesic Effects of Three Different Doses of Intrathecal Ketamine as an Adjuvant to Intrathecal Bupivacaine in Patients Undergoing Knee Arthroscopy. A Randomized Prospective Double-blinded Study

The aim of this study is to compare the postoperative analgesic effect of three different doses of intrathecal ketamine as an adjuvant to bupivacaine in patients undergoing knee arthroscopy.

Study Overview

• Status: Completed
• Conditions: Ketamine Causing Adverse Effects in Therapeutic Use
• Intervention / Treatment: Drug: Ketamine 0.1 mg; Drug: Ketamine 0.2 mg; Drug: Ketamine 0.3 mg

Detailed Description

A meta-analysis of adult human randomized controlled studies that compared single dose perioperative intrathecal ketamine plus intrathecal bupivacaine to bupivacaine alone in spinal anesthesia suggests that there is a benefit to using intrathecal ketamine as an adjunct to bupivacaine in multimodal analgesia. However, there are still knowledge and experience gaps regarding neuraxial ketamine dosing in this regard.

Aim of the study:

The aim of this study is to compare the postoperative analgesic effect of three different doses of intrathecal ketamine as an adjuvant to bupivacaine in patients undergoing knee arthroscopy.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 11111
    • Assiut University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age: 18-70 years.
• BMI: 20-30 kg.m2
• Sex: both males and females.
• ASA physical status: I-III.
• Operation: knee arthroscopy.

Exclusion Criteria:

• Patient's refusal to participate in the study.
• Aged less than 18 years,
• known allergy to L.A.,
• Coagulopathy or thrombocytopenia,
• height less than 150 cm, morbidly obese infection at the site of injection.
• Chronic pain syndromes,
• pregnant woman
• Patients on regular use of analgesic or who received analgesic 24 h before surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ketamine 0.1; Group I: will include 35 patients, will receive 3mL of bupivacaine (heavy) 0.5% in addition to 0.5 ml of a preservative-free ketamine 0.1 mg/kg	Drug: Ketamine 0.1 mg; Patients will receive 3mL of bupivacaine (heavy) 0.5% in addition to 0.5 ml of a preservative-free ketamine 0.1 mg/kg
Active Comparator: Ketamine 0.2; Group II will include 35 patients, will receive 3mL of bupivacaine (heavy) 0.5% in addition to 0.5 ml of a preservative-free ketamine 0.2 mg/kg	Drug: Ketamine 0.2 mg; will receive 3mL of bupivacaine (heavy) 0.5% in addition to 0.5 ml of a preservative-free ketamine 0.2 mg/kg
Active Comparator: Ketamine 0.3; Group III will include 35 patients, will receive 3mL of bupivacaine (heavy) 0.5% in addition to 0.5 ml of a preservative-free ketamine 0.3 mg/kg	Drug: Ketamine 0.3 mg; will receive 3mL of bupivacaine (heavy) 0.5% in addition to 0.5 ml of a preservative-free ketamine 0.3 mg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first analgesic request	From the time of intrathecal administration of the drug to the time of patient needs the first rescue analgesic drug	First 24 hours

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2022
• Primary Completion (Actual): July 10, 2023
• Study Completion (Actual): July 11, 2023

Study Registration Dates

• First Submitted: September 22, 2021
• First Submitted That Met QC Criteria: September 29, 2021
• First Posted (Actual): October 12, 2021

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: Ketamine 3 doses

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No