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Administrative data

NCT number NCT05823649
Other study ID # Postoperative feeding
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 20, 2023
Est. completion date February 1, 2024

Study information

Verified date April 2023
Source Armed Police Force Hospital, Nepal
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Armed Police Force Hospital, Nepal Nepal Orthopedic Hospital, Kathmandu, Nepal

References & Publications (21)

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Outcome

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