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

NCT ID: NCT04418674

Last Updated: 2021-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-25
• Study Completion Date: 2021-05-31

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.

Conditions

Fracture of Proximal End of Femur

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ketamine

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

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

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

Fentanyl

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

Group Type: ACTIVE_COMPARATOR

Fentanyl

Intervention Type: DRUG

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

Interventions

Ketamine

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

Intervention Type: DRUG

Fentanyl

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Patients undergoing Subarachnoid block for proximal fracture femur

1. Age: above 18 years

2. ASA PS I, II

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jenny Bajracharya

OTHER

Sponsor Role: lead

Responsible Party

Jenny Bajracharya

Department of Anesthesia, Principal Investigator, Junior resident

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Bishnu Pokharel, MS

Role: STUDY_CHAIR

B P Koirala Institute of Health and Sciences

Locations

B P Koirala Institute of Health and Sciences

Dharān, Sunsari, Nepal

Site Status: RECRUITING

B P Koirala Institute of Health and sciences

Dharān, Sunsari, Nepal

Site Status: RECRUITING

Countries

Nepal

Central Contacts

Jenny Bajracharya, MD

Role: CONTACT

bajracharya.jenny@gmail.com

9841455882 ext. +977

Krishna Pokharel, MD

Role: CONTACT

drkrishnapokharel@gmail.com

9841986321 ext. +977

Facility Contacts

Jenny Bajracharya, MBBS, MD

Role: primary

bajracharya.jenny@gmail.com

9841455882 ext. +977

Krishna Pokharel, MBBS, MD

Role: backup

drkrishnapokharel@gmail.com

0941986321 ext. +977

Jenny Bajracharya, MD

Role: primary

bajracharya.jenny@gmail.com

9841455882 ext. +977

References

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.

Reference Type: BACKGROUND

PMID: 25068412 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15385380 (View on PubMed)

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

Other Identifiers

IRC/1597/019

Identifier Type: -

Identifier Source: org_study_id