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Effect of Preoperative Carbohydrate Loading in Femur Fracture

Primary Purpose

Femur Fracture

Status
Completed
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
Carbohydrate loading
Sponsored by
Armed Police Force Hospital, Nepal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Femur Fracture focused on measuring Femur fracture, Carbohydrate loading, Visual Analogue Score (VAS), Cumulative Ambulatory Score (CAS)

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • • Patients of age 50 years and above with femur fracture scheduled for surgery under spinal anesthesia

Exclusion Criteria:

  • Pre-existing diabetes (Type I or II)
  • Previous intolerance to carbohydrate drinks
  • Pathological fracture or any suspected pathology
  • Failure case of surgery or non-union case

Sites / Locations

  • Dev Ram Sunuwar

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Usual care

Arm Description

The study group will be intervened with carbohydrate loading as the protocol made by ERAS(Li et al., 2021). We will provide glucose-D.

The control group will be kept in fasting condition from midnight as a traditional practice in existence.

Outcomes

Primary Outcome Measures

wellbeing of the patients
The visual analog scale (VAS) will be used to evaluate the well-being of the patients (pain, thirst, and hungry) after surgery. The VAS scores will be recorded on the morning of the first and second postoperative day (24, and 48 hours post-operative, respectively) for groups.
Functional mobility of the patients
The Cumulative Ambulatory Score (CAS) will be applied to find out the mobility function after surgery. The CAS scores will be recorded on the morning of the first, second, and third postoperative day (24, 48, and 72 hours post-operative, respectively) for both groups.

Secondary Outcome Measures

Change serum albumin level
Serum albumin level will be assessed after surgery for both groups

Full Information

First Posted
April 3, 2021
Last Updated
May 16, 2022
Sponsor
Armed Police Force Hospital, Nepal
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1. Study Identification

Unique Protocol Identification Number
NCT04838366
Brief Title
Effect of Preoperative Carbohydrate Loading in Femur Fracture
Official Title
The Effect of Pre-operative Carbohydrate Loading in Femur Fracture: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
August 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Armed Police Force Hospital, Nepal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Femur fracture is very common in older people. It makes the people bedridden for long time at hospital. The fracture of femur is generally managed by the surgical procedure. Prolonged fasting for surgery makes the patients harassed physically as well as mentally. The long fasting state emphasizes the body more in catabolic state which increases the insulin resistivity. Pre-operative carbohydrate loading before two hours the surgery has been launched in practice to overcome these problems in the world context, however it is not in existence in Nepal. The aim of the study is to evaluate the effect of pre-operative carbohydrate loading in the case of femur fracture surgery. This study utilize a hospital based randomized control trial study design to assess the effect of carbohydrate loading before two hours the surgery over the completely fasting state. A representative sample size of 66 patients (control group =33 and study group =33) aged 50 years and above having femur fracture planned for surgery will be selected for research. The pre-operative nutritional status will be identified and the post-operative outcomes will be measured by Visual Analogue Score (VAS) and Cumulative Ambulatory Score (CAS). Statistical analysis will be performed using chi square test, independent sample t-test or Mann-Whitney U test to compare between the outcome of study groups and control groups. The outcome of the study may provide a platform to the anaesthesiologists and surgeons towards the emerging concept of pre-operative carbohydrate loading practice in Orthopedics surgery in Nepal.
Detailed Description
Femur fracture is one of the most common cause for hospital stay in the case of elder people. Besides these, the patients have the stress of surgery. According to existing practice, the patients are kept in fasting state from the midnight that makes the patients physically as well as mentally discomfort. The patients go in the catabolic state. In addition to these, the prevalence of malnutrition in older people having hip fracture ranges from 2% to 63%. Now the new concept has been launched that the patients should be fed 50 gram carbohydrate two hours prior to the surgery, called carbohydrate loading. The study reveals that preoperative carbohydrate loading decreases the insulin resistance and improves metabolic functions. It presents the patients in anabolic state rather than catabolic state, resulting in the less post-operative protein and nitrogen loss, which facilitates the wound healing. It improves the recovery rate, and hence decreases the length of post-operative stay at hospital, that brings the smile in the face of patients and reduces the treatment cost too. Similarly, it is also associated with significantly better well-being. In Nepal, there is the practice of giving anesthesia to the patient in complete fasting state. The prolonged fasting state adds the harassment in the patients. Now, the practice of preoperative carbohydrate loading before two hours of surgery is preferred in the world context to minimize the problem of patients discomfort and to maximize better outcome. However, this type of trend is not practiced in Nepal. Furthermore, the issue of nutrition is not prioritized in orthopedics in Nepal. So, this study will also evaluate the nutritional status of the patients under study to relate with the outcomes. The sample size will be calculated based on the previous similar study with a Mean + SE of Cumulative Ambulatory score (Study groups Vs Control groups: 12.76 + 0.33 Vs 12.02 + 0.32). Considering this data with taking α level of significance at 5% and power of 80%, the sample size will be calculated using test comparing independent two means in Stata/MP version 14.1 (StataCorp LP, College Station, Texas). The calculated sample size is 60. To take into account with 10% loss through follow-up and drop out, the total sample size will be 66 (33 participants in each group.)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femur Fracture
Keywords
Femur fracture, Carbohydrate loading, Visual Analogue Score (VAS), Cumulative Ambulatory Score (CAS)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized in a 1:1 ratio, and assigned into study group and control group randomly through computer generated block randomization.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
The study group will be intervened with carbohydrate loading as the protocol made by ERAS(Li et al., 2021). We will provide glucose-D.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
The control group will be kept in fasting condition from midnight as a traditional practice in existence.
Intervention Type
Dietary Supplement
Intervention Name(s)
Carbohydrate loading
Intervention Description
study group will be intervened with carbohydrate loading as the protocol made by ERAS(Li et al., 2021). Surgical patients will be asked to drink a beverage containing 100 grams carbohydrate the night before surgery. On the day of surgery, patients will drink a beverage containing 50 grams carbohydrate 2 hours before surgery under the supervision of research team member. We will provide glucose-D (Dabur Nepal Private Limited, Bara, Nepal, (Regd No.: 3506/045/046, DFTQC No.: 01-33-55-03-218).
Primary Outcome Measure Information:
Title
wellbeing of the patients
Description
The visual analog scale (VAS) will be used to evaluate the well-being of the patients (pain, thirst, and hungry) after surgery. The VAS scores will be recorded on the morning of the first and second postoperative day (24, and 48 hours post-operative, respectively) for groups.
Time Frame
One week
Title
Functional mobility of the patients
Description
The Cumulative Ambulatory Score (CAS) will be applied to find out the mobility function after surgery. The CAS scores will be recorded on the morning of the first, second, and third postoperative day (24, 48, and 72 hours post-operative, respectively) for both groups.
Time Frame
One week
Secondary Outcome Measure Information:
Title
Change serum albumin level
Description
Serum albumin level will be assessed after surgery for both groups
Time Frame
One week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: • Patients of age 50 years and above with femur fracture scheduled for surgery under spinal anesthesia Exclusion Criteria: Pre-existing diabetes (Type I or II) Previous intolerance to carbohydrate drinks Pathological fracture or any suspected pathology Failure case of surgery or non-union case
Facility Information:
Facility Name
Dev Ram Sunuwar
City
Kathmandu
State/Province
Bagmati
ZIP/Postal Code
+977
Country
Nepal

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24417824
Citation
Bilku DK, Dennison AR, Hall TC, Metcalfe MS, Garcea G. Role of preoperative carbohydrate loading: a systematic review. Ann R Coll Surg Engl. 2014 Jan;96(1):15-22. doi: 10.1308/003588414X13824511650614.
Results Reference
result
PubMed Identifier
22035956
Citation
Breedveld-Peters JJ, Reijven PL, Wyers CE, van Helden S, Arts JJ, Meesters B, Prins MH, van der Weijden T, Dagnelie PC. Integrated nutritional intervention in the elderly after hip fracture. A process evaluation. Clin Nutr. 2012 Apr;31(2):199-205. doi: 10.1016/j.clnu.2011.10.004. Epub 2011 Oct 28.
Results Reference
result
PubMed Identifier
33731057
Citation
Li ZE, Lu SB, Kong C, Sun WZ, Wang P, Zhang ST. Comparative short-term outcomes of enhanced recovery after surgery (ERAS) program and non-ERAS traditional care in elderly patients undergoing lumbar arthrodesis: a retrospective study. BMC Musculoskelet Disord. 2021 Mar 17;22(1):283. doi: 10.1186/s12891-021-04166-z.
Results Reference
result
PubMed Identifier
29786478
Citation
From the American Association of Neurological Surgeons (AANS), American Society of Neuroradiology (ASNR), Cardiovascular and Interventional Radiology Society of Europe (CIRSE), Canadian Interventional Radiology Association (CIRA), Congress of Neurological Surgeons (CNS), European Society of Minimally Invasive Neurological Therapy (ESMINT), European Society of Neuroradiology (ESNR), European Stroke Organization (ESO), Society for Cardiovascular Angiography and Interventions (SCAI), Society of Interventional Radiology (SIR), Society of NeuroInterventional Surgery (SNIS), and World Stroke Organization (WSO); Sacks D, Baxter B, Campbell BCV, Carpenter JS, Cognard C, Dippel D, Eesa M, Fischer U, Hausegger K, Hirsch JA, Shazam Hussain M, Jansen O, Jayaraman MV, Khalessi AA, Kluck BW, Lavine S, Meyers PM, Ramee S, Rufenacht DA, Schirmer CM, Vorwerk D. Multisociety Consensus Quality Improvement Revised Consensus Statement for Endovascular Therapy of Acute Ischemic Stroke. Int J Stroke. 2018 Aug;13(6):612-632. doi: 10.1177/1747493018778713. Epub 2018 May 22. No abstract available.
Results Reference
result
PubMed Identifier
36042436
Citation
Chaudhary NK, Sunuwar DR, Sharma R, Karki M, Timilsena MN, Gurung A, Badgami S, Singh DR, Karki P, Bhandari KK, Pradhan PMS. The effect of pre-operative carbohydrate loading in femur fracture: a randomized controlled trial. BMC Musculoskelet Disord. 2022 Aug 30;23(1):819. doi: 10.1186/s12891-022-05766-z.
Results Reference
derived
Links:
URL
https://clinmedjournals.org/articles/jnmdc/journal-of-nutritional-medicine-and-diet-care-jnmdc-5-036.pdf
Description
Chada, R. R., Maryada, V. R., Mulpur, P., Reddy, A., & Maska, A. (2019). Does Preoperative Carbohydrate Loading Help Outcomes in Total Knee Replacement Surgery? J Nutri Med Diet Care, 5(1), 36.

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Effect of Preoperative Carbohydrate Loading in Femur Fracture

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