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Comparison of Analgesic Effectiveness of Intravenous Ketamine and Fentanyl for Spinal Anesthesia is Sitting Position in Patients With Proximal Femur Fracture

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ClinicalTrials.gov Identifier: NCT04418674
Recruitment Status : Recruiting
First Posted : June 5, 2020
Last Update Posted : April 6, 2021
Sponsor:
Information provided by (Responsible Party):
Jenny Bajracharya, B.P. Koirala Institute of Health Sciences

Tracking Information
First Submitted Date  ICMJE May 31, 2020
First Posted Date  ICMJE June 5, 2020
Last Update Posted Date April 6, 2021
Actual Study Start Date  ICMJE June 25, 2020
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2020)
Numeric Rating Scale for Pain [ Time Frame: 1 to 20 minutes ]
Level of analgesia for subarachnoid block in sitting position measured by Numeric Rating Rating Scale for pain. Scale ranges from 0 to 10, where 0 is no pain and 10 being maximum/ worst imaginable pain.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2020)
  • Likert Satisfaction score [ Time Frame: 1 to 20 minutes ]
    Patient satisfaction for positioning the patient for subarachnoid block using Likert score will be used. It ranges from 1 to 5 (1=strongly dissatisfied, 2=dissatisfied, 3=neutral, 4=satisfied, 5=strongly satisfied)
  • Anesthetist Satisfaction Score [ Time Frame: 1 to 20 minutes ]
    Anesthetist satisfaction for positioning the patient for subarachnoid block as good, satisfactory and Optimal
  • Number of attempts for successful spinal needle placement [ Time Frame: 1 to 20 minutes (While performing subarachnoid block) ]
    Number of attempts for successful spinal needle placement
  • Adverse effects [ Time Frame: 1 to 120 minutes (Intraoperatively) ]
    Occurrence of any adverse events like hypotension, bradycardia, hallucination, nausea and vomiting.
  • Modified Wilson Sedation Scale [ Time Frame: 1 to 120 minutes (Intraoperatively) ]
    Sedation score of the patients will be noted (1=Oriented, 2=Drowsy,3=Arousable,4=Unarousable)
  • Modified Aldrerte Score [ Time Frame: 10 to 30 minutes (In post anesthesia care unit) ]
    Time required by patients of each group to be discharged from the PACU will be noted bu using Modified Aldrerte Score (Score of 9-10=can be discharged, 8 or less=close monitoring needed)
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 Comparison of Analgesic Effectiveness of Intravenous Ketamine and Fentanyl for Spinal Anesthesia is Sitting Position in Patients With Proximal Femur Fracture
Official Title  ICMJE Comparison of Analgesic Effectiveness of Intravenous Ketamine and Fentanyl for Spinal Anesthesia is Sitting Position in Patients With Proximal Femur Fracture
Brief Summary

This is a prospective comparative study which will be conducted in patients with proximal femur fracture undergoing operative interventions under subarachnoid block in sitting position. Ketamine group will receive 0.3mg/kg intravenously and Fentanyl group will receive 1.5mcg/kg before changing the position from supine to sitting for subarachnoid block. Analgesic effectiveness of the two drugs will be compared by Numeric Rating Scale for pain.

Research hypothesis (Null hypothesis) There is no difference in analgesic effectiveness, patient satisfaction, spinal performance and occurrence of adverse effects between Intravenous ketamine and intravenous fentanyl in patients with proximal femur fracture.

Alternate hypothesis Intravenous Ketamine in patients with proximal femur fracture improves the level of analgesia, patient satisfaction, spinal performance and occurrence of adverse effects when compared to intravenous fentanyl.

Detailed Description

Femur fracture is a common orthopedic problem following trauma in patients of all ages. It is a painful bone injury and is associated with severe pain and distress during preoperative period. Surgical repair is most commonly done in subarachnoid block. However, moving the patient for optimal positioning for spinal needle placement in subarachnoid space leads to severe pain. Adequate analgesia not only improves patient's comfort but has also been shown to improve positioning for subarachnoid block. Several analgesic modalities have been used to decrease movement evoked pain in these patients including the use of intravenous analgesics and blocks. However, there are only few studies comparing intravenous analgesics that alleviated the pain that occurs when changing position for subarachnoid block.

Patient enrollment will be done by the primary investigator one day prior to the surgery. All eligible patients with American Society of Anesthesiologist Physical Status I, II fulfilling the inclusion criteria will be informed about the study and written consent will be obtained in pre operative visit, one day prior to the surgery, in the orthopedic in-patient ward.

All patients will be kept nil per oral for 6 hours for solid, heavy meal, 4 hours for light meal and 2 hours for clear liquid. All the patients will be pre-medicated with Tab Lorazepam 1mg (<50kg) and 2mg (>50kg) orally the night before and in the morning of the surgery.

On the day of surgery, randomization will be done in pre operative holding area and the patient will be transferred to the operation theatre in trolley maintaining the skeletal traction. All standard monitoring devices like electrocardiogram, non-invasive blood pressure monitoring and pulse oximeter will be attached. Standard anesthesia monitoring including 3-lead electrocardiography, oxygen saturation(Spo2), blood pressure(BP) and heart rate(HR) will be done.Baseline Numeric Rating Scale(NRS) for pain at rest and movement will be assessed (movement is defined at 5 cm active vertical movement of the limb).

An intravenous line will be secured with 18 gauge intavenous cannula in the dorsum of hand. Pre-hydration will be started with Ringer's Lactate solution at 5ml/kg/hour.

Dose of the drug required according to the body weight will be calculated and prepared by the anesthetist not involved in the study. It will be labelled as study drug and will be delivered by the investigator.

Group A will receive Inj Ketamine 0.30mg/kg bolus dose. Group B will receive Inj Fentanyl 1.5mcg/kg bolus dose. The drug will be prepared in an identical sterile syringe as a clear fluid and will be labelled as "study drug".

Patient will receive the study drug according to randomization.Then, 10 minutes after delivery of the study drug, the patients will be kept in sitting position with the help of operation theatre assistant while maintaining the skeletal traction. Numeric Rating Scale will be enquired and noted. If the patient will report Numeric Rating Scale of 5 or more during placement in the sitting position, procedure will be stopped and fentanyl 20 microgram will given intravenously in the form of rescue analgesia before attempting to reposition again. Once the patient will be in sitting position subarachnoid will be performed in L 3-4 inter space using 2.4ml of 0.5% hyperbaric bupivacaine maintaining strict asepsis. The patient will be laid down back to supine position. The level of sensory block and motor block will assessed. After ascertaining adequate block, patient will be shifted to fracture table for operation. The number attempts required for successful subarachnoid block will be noted. The quality of patient positioning will subjectively be rated as good, satisfactory and optimal depending upon the ease of positioning for subarachnoid block by the anesthetist. Sedation scoring will be noted for 30 minutes after delivery of the study drug. All the vital parameters will be monitored continuously and recorded every 3 minutes for first 15 minutes then every 10 minutes throughout the surgery and once in Post Anesthesia Care Unit. Patient will be assessed for the presence any adverse effect of the study drug throughout the surgery. The level of satisfaction regarding the analgesia during positioning will be questioned to the patient using Likert Scale in PACU. The time required for the patients to be discharged from PACU will be noted.

Data management Data handling- Data will be entered in Microsoft Excel 2016 and converted into Statistical package for social sciences (SPSS 11.5) for statistical analysis Coding-Alpha numerical code will be used Monitoring-Data will be entered after every day of work. Data will be reported to guide and co-guides every week.

Statistical Methods Collected data will be entered in Microsoft Excel 2010 and be converted into SPSS software 11.5 version for statistical analysis.

For descriptive statistics percentage, mean, Standard deviation, median, interquartile range will be calculated along with graphical and tabular presentation. For inferential statistics Chi square test, independent t test, Mann Whitney U test will be applied to find out the significant difference between Fentanyl and Ketamine with selected clinical and demographic parameter at 95% confidence interval where level of significance is considered p <0.05.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Ketamine Group: Ketamine 0.3mg/kg intavenously before changing the position from supine to sitting for subarachnoid block.

Fentanyl group: Fentanyl 1.5mcg/kg intravenously before changing the position from supine to sitting position for subarachnoid block.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

0.4ml from one 1 ml ampule of 50mg ketamine will be diluted with 9.6ml NS to make a concentration of 2mg Ketamine in each ml in a 10 ml syringe.

One 2ml ampule of 100mcg Fentanyl will be diluted with 8 ml NS to make a concentration of 10mcg in each ml in a 10ml syringe

Ketamine and Fentanyl will be administered as clear fluid from a 10ml syringe labelled as Study drug, therefore, both the patient and investigator will be blinded.

Primary Purpose: Treatment
Condition  ICMJE Fracture of Proximal End of Femur
Intervention  ICMJE
  • Drug: Ketamine
    in this group, patient will receive ketamine at 0.3mg/kg intravenously.
  • Drug: Fentanyl
    In this group, the patients will receive fentanyl at 1.5mcg/kg intavenously.
Study Arms  ICMJE
  • Experimental: Ketamine
    Patient will be given Ketamine 0.3mg/kg intravenously before sitting positioning for subarachnoid block.
    Intervention: Drug: Ketamine
  • Active Comparator: Fentanyl
    Patient will be given Fentanyl 1.5mcg/kg intravenously before sitting position for subarachnoid block.
    Intervention: Drug: Fentanyl
Publications *

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 3, 2020)
52
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2021
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  1. Inclusion criteria:

    Patients undergoing Subarachnoid block for proximal fracture femur

    1. Age: above 18 years
    2. ASA PS I, II
  2. Exclusion criteria:

    1. Refusal to participate in the study
    2. Other painful co- morbidities
    3. Allergy or any contraindication to study medication
    4. Any contraindication to subarachnoid block
    5. Analgesics 8 hours prior to performing sunarachnoid block
    6. Pathologic fractures
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jenny Bajracharya, MD 9841455882 ext +977 bajracharya.jenny@gmail.com
Contact: Krishna Pokharel, MD 9841986321 ext +977 drkrishnapokharel@gmail.com
Listed Location Countries  ICMJE Nepal
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04418674
Other Study ID Numbers  ICMJE IRC/1597/019
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
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jenny Bajracharya, B.P. Koirala Institute of Health Sciences
Study Sponsor  ICMJE Jenny Bajracharya
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Bishnu Pokharel, MS B P Koirala Institute of Health and Sciences
PRS Account B.P. Koirala Institute of Health Sciences
Verification Date June 2020

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