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

Primary Purpose

Lower Limb Fracture

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Early feeding/intervention group
Sponsored by
Armed Police Force Hospital, Nepal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Limb Fracture focused on measuring Postoperative diet, Early feeding, Delayed feeding, Lower limb fracture

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Early feeding/intervention group

    Delayed feeding/control group

    Arm Description

    The postoperative patients will be intervened after one to two hours from the entry of the patients to the postoperative ward.

    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.

    Outcomes

    Primary Outcome Measures

    Incidence of Nausea and vomiting
    The primary outcome will be the comparison of incidence of nausea and vomiting in early versus delayed postoperative feeding.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    March 20, 2023
    Last Updated
    April 10, 2023
    Sponsor
    Armed Police Force Hospital, Nepal
    Collaborators
    Nepal Orthopedic Hospital, Kathmandu, Nepal
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05823649
    Brief Title
    Effect of Early Versus Delayed Postoperative Feeding in Lower Limb Fracture Surgery
    Official Title
    Effect of Early Versus Delayed Postoperative Feeding in Lower Limb Fracture Surgery: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 20, 2023 (Anticipated)
    Primary Completion Date
    December 1, 2023 (Anticipated)
    Study Completion Date
    February 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lower Limb Fracture
    Keywords
    Postoperative diet, Early feeding, Delayed feeding, Lower limb fracture

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Oral feeding
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    275 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Early feeding/intervention group
    Arm Type
    Experimental
    Arm Description
    The postoperative patients will be intervened after one to two hours from the entry of the patients to the postoperative ward.
    Arm Title
    Delayed feeding/control group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Early feeding/intervention group
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Incidence of Nausea and vomiting
    Description
    The primary outcome will be the comparison of incidence of nausea and vomiting in early versus delayed postoperative feeding.
    Time Frame
    Two weeks
    Secondary Outcome Measure Information:
    Title
    Change in postoperative pain
    Description
    Measure the change of postoperative pain between intervention and control groups using Visual Analogue Scale (VAS).
    Time Frame
    Two weeks
    Title
    Improved hand grip strength
    Description
    Measure the hand grip strength using the hand grip dynamometer of the patients between intervention and control groups
    Time Frame
    Two weeks
    Title
    Length of hospital stay
    Description
    Assess the length of hospital stay between intervention and control groups
    Time Frame
    Two weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    We do not have a plan to share individual participant data.
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    Effect of Early Versus Delayed Postoperative Feeding in Lower Limb Fracture Surgery

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