Comparing Three Different Doses of Intrathecal Ketamine

NCT ID: NCT05074823

Last Updated: 2023-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-26

Study Completion Date

2023-07-11

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ketamine Causing Adverse Effects in Therapeutic Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Ketamine 0.1 mg

Intervention Type DRUG

Patients will receive 3mL of bupivacaine (heavy) 0.5% in addition to 0.5 ml of a preservative-free ketamine 0.1 mg/kg

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

Group Type ACTIVE_COMPARATOR

Ketamine 0.2 mg

Intervention Type DRUG

will receive 3mL of bupivacaine (heavy) 0.5% in addition to 0.5 ml of a preservative-free ketamine 0.2 mg/kg

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

Group Type ACTIVE_COMPARATOR

Ketamine 0.3 mg

Intervention Type DRUG

will receive 3mL of bupivacaine (heavy) 0.5% in addition to 0.5 ml of a preservative-free ketamine 0.3 mg/kg

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mostafa Samy Abbas

associate professor of anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut University hospital

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Ketamine 3 doses

Identifier Type: -

Identifier Source: org_study_id

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