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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05074823

Enrollment

105

Registered

2021-10-12

Start date

2022-02-26

Completion date

2023-07-11

Last updated

2023-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ketamine Causing Adverse Effects in Therapeutic Use

Brief summary

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

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.

Interventions

DRUGKetamine 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

DRUGKetamine 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

DRUGKetamine 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026