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

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ClinicalTrials.gov Identifier: NCT03357055
Recruitment Status : Unknown
Verified December 2017 by Dr Foo Li Lian, University of Malaya.
Recruitment status was:  Not yet recruiting
First Posted : November 29, 2017
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Dr Foo Li Lian, University of Malaya

Tracking Information
First Submitted Date  ICMJE November 15, 2017
First Posted Date  ICMJE November 29, 2017
Last Update Posted Date December 13, 2017
Estimated Study Start Date  ICMJE December 13, 2017
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2017)
Change in pain scores among patients in ketamine group vs patients in saline group, for patients undergoing lower limb surgery under spinal anaesthesia. [ Time Frame: Pain scores will be assessed at baseline and throughout tourniquet application, at 10 minute intervals until 10 minutes after tourniquet deflation. ]
Pain Score of 10-30mm: Mild pain Pain Score of 40-60mm: Moderate pain Pain Score of 70-100mm: Severe pain
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2017)
Change in blood pressure in ketamine group vs saline group, for patients undergoing lower limb surgery under spinal anaesthesia. [ Time Frame: SBP, DBP, MAP and HR will be assessed at baseline and throughout tourniquet application, at 10 minute intervals until 10 minutes after tourniquet deflation ]
Systolic, Diastolic blood pressure, Mean arterial pressure, heart rate
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine Reduces Tourniquet Pain In Patients Undergoing Lower Limb Surgery Under Spinal Anaesthesia
Official Title  ICMJE Ketamine Reduces Tourniquet Pain In Patients Undergoing Lower Limb Surgery Under Spinal Anaesthesia
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.

Detailed Description

Primary Objective 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.

This will be a prospective, double blind, randomised controlled trial by multiple operators, who are medical officers in the Department of Anaesthesia, University Malaya Medical Centre. 60 patients will be recruited into the study. All patients recruited will be subjected to standard dose of spinal anaesthesia and randomly assigned into 2 different groups.

Methodology Patients will be fasted for at least 6 hours prior to their surgery. Oral midazolam 7.5 mg will be given to healthy adult from age 18-60 and 3.75mg will be given to adult age range from 60-65years as premedication prior to sending patients to the operating theatre.

Patients will be randomly assigned by principal investigator into one of two groups by using computer generated randomized numbers:

  1. Control group will receive an intravenous (IV) infusion of 10 ml of normal saline in a 10 ml syringe over 10 minutes start 10 minutes before pneumatic tourniquet inflation. Throughout procedure patient will receive 10ml/hour normal saline infusion until operation finish.
  2. Ketamine group will receive an IV infusion of 0.25mg/kg of ketamine in a 10 ml syringe over 10 minutes start 10 minutes before pneumatic tourniquet inflation. Throughout procedure patient will receive 0.25mg/kg of ketamine infusion in a 10ml syringe running at 10ml/hour until operation finish.

The study drug will be prepared on the morning of surgery by the principal investigator and anaesthetists in charge of the case is blinded to the grouping and to the drug. Standard monitoring with continuous electrocardiography (ECG), non-invasive blood pressure (NIBP) monitoring and pulse oximetry will be used for all patients. IV access will be established and co-loading of IV Hartman's solution 10ml/kg will be given. A baseline blood pressure reading of systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) and heart rate (HR) will be taken prior to spinal anaesthesia. Patients will receive a spinal anaesthesia under aseptic technique using a 25-27 gauge Pencan® spinal needle. They will be given a dose of heavy bupivacaine 0.5% 2.5mls with fentanyl 20mcg added into the solution.

A pneumatic tourniquet using will be applied to the lower limb and inflated at 250mmHg above the systolic blood pressure. No additional sedation will be given to the patient intra-operatively.

Pain score will be assessed by blinded investigator using the 100 mm visual analog scale for pain (VAS for pain). Pain score using the VAS of 0 mm to 100mm will be recorded before application of the tourniquet(baseline), immediately after application of the tourniquet and thereafter every 10 minutes. SBP, DBP, MAP and HR will also be recorded at 10 minute intervals after the start of tourniquet inflation. The VAS and the blood pressure will be recorded at 10 minutes interval until the first reading after tourniquet deflation.

During the study period, if the VAS for pain score exceeds 40mm or if the SBP is elevated more than 30%, a dose of IV fentanyl 0.5 mcg/kg will be administered as rescue analgesia at 5 minutes interval and it will be recorded. If more than 3 doses of fentanyl given, case will be dropped out and manage according to local protocol (convert to general anaesthesia). If the SBP is persistently elevated more than 30% after 3 doses of IV fentanyl, they will be given IV labetalol 2.5mg and converted to GA and they will be dropped out from the study.

Maximum duration of tourniquet inflation was 130 minutes, after which surgeon would be advised to momentarily deflate the tourniquet and the study would be ended.

Statistical Analysis Normally distributed continuous data will be analyzed using t-test while non-parametric data will be analyzed by Mann Whitney U test using IBM SPSS Statistic version 23. Categorical data will be analyzed with Chi-square test and its non-parametric equivalent, Fisher's Exact test where appropriate. A p value < 0.05 will be regarded as statistically significant.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Tourniquet Pain
Intervention  ICMJE
  • Drug: Ketamine
    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.
  • Drug: Normal saline
    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
Study Arms  ICMJE
  • Experimental: Ketamine arm
    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.
    Intervention: Drug: Ketamine
  • Placebo Comparator: Control arm
    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.
    Intervention: Drug: Normal saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 23, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2018
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 1. 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

Exclusion Criteria:

  • 1. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03357055
Other Study ID Numbers  ICMJE NMRR-17-2459-34013.
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr Foo Li Lian, University of Malaya
Study Sponsor  ICMJE Dr Foo Li Lian
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Li Lian Foo Anaesthesiologist, Department of Anaesthesia, University Malaya Medical Centre
PRS Account University of Malaya
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP