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

NCT04418674 | Unknown

• 1 other identifier: IRC/1597/019
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

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.

Conditions

Fracture of Proximal End of Femur

Keywords

Spinal anesthesia; Ketamine; Fentanyl

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scale for Pain

  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.

  1 to 20 minutes

Secondary Outcomes (6)

• Likert Satisfaction score

  1 to 20 minutes

• Anesthetist Satisfaction Score

  1 to 20 minutes

• Number of attempts for successful spinal needle placement

  1 to 20 minutes (While performing subarachnoid block)

• Adverse effects

  1 to 120 minutes (Intraoperatively)

• Modified Wilson Sedation Scale

  1 to 120 minutes (Intraoperatively)

Study Arms (2)

Ketamine

EXPERIMENTAL

Patient will be given Ketamine 0.3mg/kg intravenously before sitting positioning for subarachnoid block.

Drug: Ketamine

Fentanyl

ACTIVE COMPARATOR

Patient will be given Fentanyl 1.5mcg/kg intravenously before sitting position for subarachnoid block.

Drug: Fentanyl

Interventions

Ketamine DRUG

in this group, patient will receive ketamine at 0.3mg/kg intravenously.

Ketamine

Fentanyl DRUG

In this group, the patients will receive fentanyl at 1.5mcg/kg intavenously.

Fentanyl

Eligibility Criteria

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

You may qualify if:

• Patients undergoing Subarachnoid block for proximal fracture femur
• Age: above 18 years
• ASA PS I, II

You may not qualify if:

• Refusal to participate in the study
• Other painful co- morbidities
• Allergy or any contraindication to study medication
• Any contraindication to subarachnoid block
• Analgesics 8 hours prior to performing sunarachnoid block
• Pathologic fractures

Sponsors & Collaborators

• Jenny Bajracharya: lead

Study Sites (2)

B P Koirala Institute of Health and Sciences

Dharān, Sunsari, 56700, Nepal

RECRUITING

B P Koirala Institute of Health and sciences

Dharān, Sunsari, Nepal

RECRUITING

Related Publications (4)

• Diakomi M, Papaioannou M, Mela A, Kouskouni E, Makris A. Preoperative fascia iliaca compartment block for positioning patients with hip fractures for central nervous blockade: a randomized trial. Reg Anesth Pain Med. 2014 Sep-Oct;39(5):394-8. doi: 10.1097/AAP.0000000000000133.

  PMID: 25068412 BACKGROUND

• Sia S, Pelusio F, Barbagli R, Rivituso C. Analgesia before performing a spinal block in the sitting position in patients with femoral shaft fracture: a comparison between femoral nerve block and intravenous fentanyl. Anesth Analg. 2004 Oct;99(4):1221-1224. doi: 10.1213/01.ANE.0000134812.00471.44.

  PMID: 15385380 BACKGROUND

• The safety, benefits and effectiveness of different intravenous subanesthetic doses of ketamine when combined with small dose of midazolam before combined spinal epidural technique for Orthopedic Lower Extremity Surgery Moataz Moataz Morad El-Tawil Anesthesia Department, Faculty of Medicine, Menoufya University Abstract

  BACKGROUND

• Aral A Mohammed, MD*, Mayada M Ali, MD.Ketamine analgesia before spinal anesthesia for fractured femur. Sudan Med J 2015;April;51(1)

  BACKGROUND

MeSH Terms

Interventions

Ketamine; Fentanyl

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Bishnu Pokharel, MS

  B P Koirala Institute of Health and Sciences

  STUDY CHAIR

Central Study Contacts

Jenny Bajracharya, MD

CONTACT

9841455882; bajracharya.jenny@gmail.com

Krishna Pokharel, MD

CONTACT

9841986321; drkrishnapokharel@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Anesthesia, Principal Investigator, Junior resident

Model Details: 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.

Study Record Dates

• First Submitted: May 31, 2020
• First Posted: June 5, 2020
• Study Start: June 25, 2020
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: April 6, 2021

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

NE (2)