Effect of Preoperative Carbohydrate Loading in Femur Fracture

Femur Fracture Clinical Trial

Official title:

The Effect of Pre-operative Carbohydrate Loading in Femur Fracture: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04838366
• Other study ID #: Carbohydrateloading
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: August 1, 2021

Study information

• Verified date: April 2021
• Source: Armed Police Force Hospital, Nepal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 1, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Femoral Fractures
• Femur Fracture
• Fractures, Bone

Intervention

Dietary Supplement:
• Carbohydrate loading
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).

Locations

Country	Name	City	State
Nepal	Dev Ram Sunuwar	Kathmandu	Bagmati

Sponsors (1)

Lead Sponsor	Collaborator
Armed Police Force Hospital, Nepal

Country where clinical trial is conducted

Nepal, 

References & Publications (4)

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. Review. — View 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 — View 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 — View 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 Dis — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One week
Primary	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.	One week
Secondary	Change serum albumin level	Serum albumin level will be assessed after surgery for both groups	One week

External Links

•   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.