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

NCT05823649 | Unknown DMC

• 1 other identifier: Postoperative feeding
• Study Type: interventional
• Target: 275
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lower Limb Fracture

Keywords

Postoperative diet; Early feeding; Delayed feeding; Lower limb fracture

Outcome Measures

Primary Outcomes (1)

• Incidence of Nausea and vomiting

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

  Two weeks

Secondary Outcomes (3)

• Change in postoperative pain

  Two weeks

• Improved hand grip strength

  Two weeks

• Length of hospital stay

  Two weeks

Study Arms (2)

Early feeding/intervention group

EXPERIMENTAL

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

Delayed feeding/control group

ACTIVE COMPARATOR

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

Interventions

Early feeding/intervention group DIETARY_SUPPLEMENT

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.

Delayed feeding/control group; Early feeding/intervention group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Armed Police Force Hospital, Nepal: lead
• Nepal Orthopedic Hospital, Kathmandu, Nepal: collaborator

Related Publications (21)

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Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dietitian and Researcher

Model Details: Oral feeding

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 21, 2023
• Study Start: April 20, 2023
• Primary Completion: December 1, 2023
• Study Completion: February 1, 2024
• Last Updated: April 21, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share