Comparing Three Different Doses of Intrathecal Ketamine

Assiut University

Status and phase: Completed; Phase 4

Conditions: Ketamine Causing Adverse Effects in Therapeutic Use

Treatments: Drug: Ketamine 0.1 mg; Drug: Ketamine 0.2 mg; Drug: Ketamine 0.3 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05074823

Ketamine 3 doses

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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105 participants in 3 patient groups

Ketamine 0.1

Active Comparator group

Description:

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

Treatment:

Drug: Ketamine 0.1 mg

Ketamine 0.2

Active Comparator group

Description:

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

Treatment:

Drug: Ketamine 0.2 mg

Ketamine 0.3

Active Comparator group

Description:

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

Treatment:

Drug: Ketamine 0.3 mg