Effect of Early Versus Delayed Postoperative Feeding in Lower Limb Fracture Surgery

April 10, 2023 updated by: Dev Ram Sunuwar, Armed Police Force Hospital, Nepal

Effect of Early Versus Delayed Postoperative Feeding in Lower Limb Fracture Surgery: a Randomized Controlled Trial

The treatment of lower limb fracture accounting one third of total fracture is a complex problem for the surgical and rehabilitation team. Patients are kept in long term fasting after surgery to prevent from postoperative complications, but it leads to the surgical catabolism resulting delaying the desired improvement in patients. To our knowledge, it has not been widely implemented in clinical settings. Therefore, the aim of the study is to evaluate the effect of early versus delayed postoperative oral feeding in lower limb fracture surgery under regional block anesthesia.

This study utilize single-center, hospital based, open-label, parallel group randomized controlled trial to assess the effect of early postoperative oral feeding in two hours after the surgery over the conventionally delayed feeding. A representative sample size of 275 patients (control group=138 and study group =137) aged 18 years and above having lower limb fracture operated under regional block will be selected for research. The pre-operative nutritional status will be identified with Simplified Nutritional Appetite Questionnaire (SNAQ) and the post-operative outcomes will be measured by Numerical Rating Scale (NRS) system. Preoperative as well as postoperative hand grip strength and Neutrophil Lymphocyte Ratio (NLR) will be assessed. Statistical analysis will be performed using chi square test, Student two sample t-test to compare between the outcome of study and control groups. The outcome of the study may provide an empirical evidence to the anesthesiologists and surgeons towards the emerging concept of postoperative early oral feeding practice in lower limb fracture surgery in clinical settings.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Orthopedic conditions are the physical injuries related to the musculoskeletal system of an individual. The overall incidence of musculoskeletal injury in low- and lower-middle income countries (LMICs) range from 779 to 1574 per 100,000 person-years. Fracture is one of the main cause of injury showing 1,229 per 100,000 individuals. The most common injury due to the road traffic accident was the 69 % fracture with fractures of tibia/fibula accounted as 30.3%. The road traffic injury (RTI) in Nepal for the period 2001-2013 also revealed that the most common fractures are lower extremities and upper extremities. About one third of the total fracture accounted for lower limb fracture and its complications lead to reason for hospital stay. Surgical management for the lower extremities fracture allows quick stabilization of fractures and early mobilization, hence accelerates the return to usual daily life activities. In fact, lower extremities fracture is a complex problem for the surgical and rehabilitation team. Pain as postoperative outcome is associated with many factors like age, duration of surgery, type of surgery, site of surgery, use of anesthesia, ethnicity, and others. Nutritional status is a strong predictor of postoperative outcomes in orthopedics for the preservation of muscle mass, strength and functionality of movement, and therefore it is recognized as an important component of surgical recovery programs. Nutritional assessment includes subjective as well as objective parameters. There are many tools for examining malnutrition and nutritional assessment as subjective parameters. Similarly, different laboratory markers such as albumin, pre-albumin, total lymphocytes, total cholesterol, C-reactive protein, transferrin are considered the objective parameter for the nutritional status evaluation. Higher the pre- and postoperative Neutrophil Lymphocyte Ratio (NLR) is associated with a higher long-term mortality risk in hip fracture surgery in elder people. Nutritional intervention is crucial for enhanced recovery after surgery. Preoperative carbohydrate loading as nutritional intervention is one component of Enhanced Recovery after Surgery (ERAS) which reduces insulin resistivity and postoperative infection. Another study found that preoperative carbohydrate loading in femur fracture has facilitated the ambulatory function, reduced the postoperative pain and hence reduced the length of hospital stay.

Patients are kept in long term fasting after surgery to prevent from postoperative complications. In fact, postoperative fasting leads to surgical catabolism and has increased the ICU stay among cancer patients undergoing elective cancer surgery. Early feeding after surgery challenges the concept of increased incidence of nausea and vomiting, and so late re-feeding has no advantages. Immediate postoperative re-feeding in orthopedic surgery is safe. Earlier post-operative feeding reduce the infection complications, improve healing, and decrease length of stay, so oral feeding should be resumed as soon as possible after surgery, with the goal of returning to solid foods within 24 hours. Previous study found that around 25 gram of essential amino acid can be fed orally within 30 minutes after surgery to facilitate the injury recovery and rehabilitation among athletes. A randomized controlled trial shows that early postoperative feeding at 4 hours is safe, and the traditional policy of starting feeding after 8 hours is outmoded under general anesthesia in orthopedics. The recommendation 5 of European Society for Clinical Nutrition and Metabolism (ESPEN) which states that enteral feeding can be initiated immediately after surgery. However, postoperative patients are mostly re-fed only after 4-6 hours of the surgery followed by the regional anesthesia (spinal, epidural or nerve block). Therefore, the study is intended to evaluate the effect of early postoperative oral feeding in the lower limb fracture surgery under regional block anesthesia.

Study Type

Interventional

Enrollment (Anticipated)

275

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients aged 18 to 60 years undergoing the lower limb fracture surgery under regional anesthesia
  • Intermediate to major categories of surgeries
  • American Society of Anesthesiologists (ASA) I and II

Exclusion Criteria:

  • Cognitive dysfunction
  • Pathological fracture
  • Fracture more than one site
  • Redo/follow-up surgery
  • Unanticipated intraoperative complications
  • Use of intraoperative drugs that causes the postoperative nausea and vomiting
  • Gastrointestinal disorder such as peptic ulcer, hiatus hernia, peptic ulcer, irritable bowel syndrome or esophagitis
  • History of gastrointestinal surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early feeding/intervention group
The postoperative patients will be intervened after one to two hours from the entry of the patients to the postoperative ward.
Dietary supplement: Early feeding/intervention group
The patients will be given orally 5 to 10 ml of warm water as first feeding. If there will be no problem of swallowing and other clinical complication, they will be further provided 20 ml of water after 10 minutes. If further patients do not suffer from nausea, vomiting and other discomfort, 100 ml clear fluid or less than it will be provided as based on the protocol followed by the study. We will use oral rehydration solution (ORS) as clear fluid.
Active Comparator: Delayed feeding/control group
The postoperative patients will be fed delayed as traditionally practiced for long time as per the hospital's protocol that breaks the postoperative fasting only after four to six hours of the surgery according to the patient condition. The guideline of the hospital recommends the patients to drink black tea as first postoperative feeding and then facilitated by the semi-solid diet, especially mushy rice which is generally cooked by mixture of rice, vegetables and pulses with salt and a lot of water.
Dietary supplement: Early feeding/intervention group
The patients will be given orally 5 to 10 ml of warm water as first feeding. If there will be no problem of swallowing and other clinical complication, they will be further provided 20 ml of water after 10 minutes. If further patients do not suffer from nausea, vomiting and other discomfort, 100 ml clear fluid or less than it will be provided as based on the protocol followed by the study. We will use oral rehydration solution (ORS) as clear fluid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Nausea and vomiting
Time Frame: Two weeks
The primary outcome will be the comparison of incidence of nausea and vomiting in early versus delayed postoperative feeding.
Two weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in postoperative pain
Time Frame: Two weeks
Measure the change of postoperative pain between intervention and control groups using Visual Analogue Scale (VAS).
Two weeks
Improved hand grip strength
Time Frame: Two weeks
Measure the hand grip strength using the hand grip dynamometer of the patients between intervention and control groups
Two weeks
Length of hospital stay
Time Frame: Two weeks
Assess the length of hospital stay between intervention and control groups
Two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Armed Police Force Hospital, Nepal

Collaborators

Nepal Orthopedic Hospital, Kathmandu, Nepal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 20, 2023

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

February 1, 2024

Study Registration Dates

First Submitted

March 20, 2023

First Submitted That Met QC Criteria

April 10, 2023

First Posted (Actual)

April 21, 2023

Study Record Updates

Last Update Posted (Actual)

April 21, 2023

Last Update Submitted That Met QC Criteria

April 10, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Postoperative feeding

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We do not have a plan to share individual participant data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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