Effect of Preoperative Carbohydrate Loading in Femur Fracture

NCT04838366 | Completed DMC

• 1 other identifier: Carbohydrateloading
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Femur Fracture

Keywords

Femur fracture; Carbohydrate loading; Visual Analogue Score (VAS); Cumulative Ambulatory Score (CAS)

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Change serum albumin level

  One week

Study Arms (2)

Intervention

EXPERIMENTAL

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

Dietary Supplement: Carbohydrate loading

Usual care

NO INTERVENTION

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

Interventions

Carbohydrate loading DIETARY_SUPPLEMENT

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).

Intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Armed Police Force Hospital, Nepal: lead

Study Sites (1)

Dev Ram Sunuwar

Kathmandu, Bagmati, +977, Nepal

Location

Related Publications (5)

• 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.

  PMID: 24417824 RESULT

• 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.

  PMID: 22035956 RESULT

• 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.

  PMID: 33731057 RESULT

• 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.

  PMID: 29786478 RESULT

• 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.

  PMID: 36042436 DERIVED

Related 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.

MeSH Terms

Conditions

Femoral Fractures

Interventions

Diet, Carbohydrate Loading

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dietitian/Researcher

Model Details: Participants will be randomized in a 1:1 ratio, and assigned into study group and control group randomly through computer generated block randomization.

Study Record Dates

• First Submitted: April 3, 2021
• First Posted: April 9, 2021
• Study Start: June 1, 2021
• Primary Completion: July 30, 2021
• Study Completion: August 1, 2021
• Last Updated: May 20, 2022

Record last verified: 2021-04

Locations

NE (1)