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Comparing Three Different Doses of Intrathecal Ketamine

Phase 4
Completed
Conditions
Ketamine Causing Adverse Effects in Therapeutic Use
Interventions
Registration Number
NCT05074823
Lead Sponsor
Assiut University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
105
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Ketamine 0.1Ketamine 0.1 mgGroup 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
Ketamine 0.3Ketamine 0.3 mgGroup 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
Ketamine 0.2Ketamine 0.2 mgGroup 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
Primary Outcome Measures
NameTimeMethod
Time to first analgesic requestFirst 24 hours

From the time of intrathecal administration of the drug to the time of patient needs the first rescue analgesic drug

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Assiut University hospital

🇪🇬

Assiut, Egypt

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