Comparing Three Different Doses of Intrathecal Ketamine

Sponsor

Assiut University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05074823

Collaborator

(none)

105

Enrollment

Location

Arms

5.5

Anticipated Duration (Months)

19.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ketamine Causing Adverse Effects in Therapeutic Use	Drug: Ketamine 0.1 mg Drug: Ketamine 0.2 mg Drug: Ketamine 0.3 mg	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

105 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Feb 26, 2022

Anticipated Primary Completion Date :

Aug 10, 2022

Anticipated Study Completion Date :

Aug 11, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut University hospital	Assiut		Egypt	11111

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mostafa Samy Abbas, associate professor of anesthesia, Assiut University

ClinicalTrials.gov Identifier:

NCT05074823

Other Study ID Numbers:

Ketamine 3 doses

First Posted:

Oct 12, 2021

Last Update Posted:

Apr 22, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Ketamine

Study Results

No Results Posted as of Apr 22, 2022