Ketamine Reduces Tourniquet Pain In Patients Undergoing Lower Limb Surgery Under Spinal Anaesthesia

NCT03357055 | Unknown Phase 4

• 1 other identifier: NMRR-17-2459-34013.
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

A prospective, double blind, randomised controlled trial to evaluate the effect of ketamine in reducing tourniquet pain for patients undergoing lower limb surgery under spinal anaesthesia. Secondary Objective To evaluate the effect of ketamine in attenuating TIH for patients undergoing lower limb surgery under spinal anaesthesia.

Conditions

Tourniquet Pain

Keywords

tourniquet, pain, ketamine

Outcome Measures

Primary Outcomes (1)

• Change in pain scores among patients in ketamine group vs patients in saline group, for patients undergoing lower limb surgery under spinal anaesthesia.

  Pain Score of 10-30mm: Mild pain Pain Score of 40-60mm: Moderate pain Pain Score of 70-100mm: Severe pain

  Pain scores will be assessed at baseline and throughout tourniquet application, at 10 minute intervals until 10 minutes after tourniquet deflation.

Secondary Outcomes (1)

• Change in blood pressure in ketamine group vs saline group, for patients undergoing lower limb surgery under spinal anaesthesia.

  SBP, DBP, MAP and HR will be assessed at baseline and throughout tourniquet application, at 10 minute intervals until 10 minutes after tourniquet deflation

Study Arms (2)

Ketamine arm

EXPERIMENTAL

Ketamine group will receive an IV infusion of 0.25mg/kg of ketamine in a 10 ml syringe over 10 minutes starting 10 minutes before pneumatic tourniquet inflation. Throughout the procedure patients will receive 0.25mg/kg of ketamine infusion at 10ml/hour until the end of operation.

Drug: Ketamine

Control arm

PLACEBO COMPARATOR

Control group will receive an intravenous (IV) infusion of 10 ml of normal saline in a 10 ml syringe over 10 minutes starting 10 minutes before pneumatic tourniquet inflation. Throughout the procedure, patients will receive 10ml/hour normal saline infusion until the end of operation.

Drug: Normal saline

Interventions

Ketamine DRUG

IV infusion of 0.25mg/kg of ketamine over 10 minutes before pneumatic tourniquet inflation. Throughout procedure patient will receive 0.25mg/kg of ketamine infusion.

Ketamine arm

Normal saline DRUG

Control group will receive an intravenous (IV) infusion of 10 ml of normal saline in a 10 ml syringe over 10 minutes starting 10 minutes before pneumatic tourniquet inflation. Throughout the procedure, patients will receive 10ml/hour normal saline infusion until the end of operation

Control arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. ASA I or II 2. Age between 18-65 years old undergoing lower limb surgeries under spinal anaesthesia with pneumatic tourniquet inflation time more than 60 minutes

You may not qualify if:

• \. Allergic to ketamine 2. Patients who have any degree of heart block, cardiovascular diseases, uncontrolled hypertension, severe peripheral vascular disease, sickle cell disease, diabetes neuropathy, deep vein thrombosis and pulmonary embolism, liver and renal impairment.

Sponsors & Collaborators

• Dr Foo Li Lian: lead

MeSH Terms

Conditions

Pain

Interventions

Ketamine; Saline Solution

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Li Lian Foo

  Anaesthesiologist, Department of Anaesthesia, University Malaya Medical Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Lian Foo

CONTACT

+60379492052; li_lian@ummc.edu.my

Chew Yin Wang

CONTACT

+60379492052

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anaesthesiologist

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 29, 2017
• Study Start: December 13, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: December 13, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share