A clinical study comparing Enhanced recovery after surgery (ERAS) protocol and conventional recovery strategy for evaluation of postoperative recovery in terms of length of hospital stay in children undergoing lower limb bone surgeries
- Conditions
- Measurement and Monitoring, (2) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified,
- Registration Number
- CTRI/2023/07/055154
- Brief Summary
The study was conducted after approval from the institutional ethical committee (IEC) and registered with clinical trials registry-India (CTRI). A detailed pre-anaesthetic check-up and investigations were done for all patients. Informed consent (Annexure II) was taken from parents before the participation of their children in the study. Observation and data collection were done by the same observer.
Group C - Conventional recovery strategy
Group E - ERAS protocol
**GROUP C**
A written informed parental consent was taken. Patients were kept nil per oral prior to surgery as per standard ASA guidelines (8 hours for solid food, 6 hours for semisolid food, 2 hours for clear liquids). The patients were pre-medicated with oral midazolam (0.5 mg/kg) 30 minutes before the surgical procedure. After arrival in the operating room, a 22G/24G peripheral intravenous catheter was inserted. Standard monitoring was applied, including non-invasive blood pressure (NIBP), electrocardiograph (ECG) with heart rate (HR) and pulse oximetry (SpO2).
Pre-medication was administered with intravenous injection (inj.) ondansetron (0.15mg/kg) and inj. fentanyl 2 µg/kg. Patients were pre-oxygenated with 100% oxygen for 3 minutes and anaesthesia was induced intravenously with slow administration of inj. propofol 2mg/kg. After confirming adequate depth of anaesthesia, a weight appropriate supraglottic airway device (SGD) was placed. Adequate ventilation was ensured and patient was placed in the left lateral position for caudal block. Under aseptic precautions, 0.75 ml/kg solution of 0.25% bupivacaine with clonidine 1 µg/kg was administered. Anaesthesia was maintained with oxygen, nitrous oxide (N2O) and sevoflurane, maintaining a minimum alveolar concentration (MAC) of 1-1.2, with the patient on assisted mechanical ventilation. Electrocardiographs with HR, NIBP, SpO2, EtCO2, end tidal anaesthetic gas concentration, MAC and temperature were monitored for all patients throughout. Inj. paracetamol 15 mg/kg was given intravenously half an hour before the expected completion of surgery. After the surgery is over, all inhalational anaesthetic agents were stopped and SGD removed when the patient was conscious. The patient was shifted to post anaesthesia care unit (PACU) and was kept nil per oral for 4 hours.
**GROUP E**
A written informed parental consent was taken. Parents were counselled about the ERAS, illustration of FACES score and its significance in the postoperative period. Patients were kept nil per oral prior to surgery as per standard ASA guidelines (8 hours for solid food, 6 hours for semisolid food, 2 hours for clear liquids). However, it was ensured that they have clear fluids 2 hours prior to surgery. The patients were pre-medicated with oral midazolam (0.5mg/kg) 30 minutes before the surgical procedure. After arrival in the operating room, a 22G/24G peripheral intravenous catheter was inserted. Standard monitoring was applied, including non-invasive blood pressure (NIBP), electrocardiograph (ECG) with heart rate (HR) and pulse oximetry (SpO2).
Pre-medication was administered with intravenous injection (inj.) ondansetron (0.15mg/kg) and inj. ketamine 1 mg/kg. Patients were pre-oxygenated with 100% oxygen for 3 minutes and anaesthesia was induced intravenously with slow administration of inj. propofol 2 mg/kg. After confirming adequate depth of anaesthesia, a weight appropriate SGD was placed. Adequate ventilation was ensured and patient placed in the left lateral position for caudal block. Under aseptic precautions, 0.75 ml/kg solution of 0.25% bupivacaine with clonidine 1 µg/kg was administered. Anaesthesia was maintained with oxygen, nitrous oxide (N2O) and sevoflurane, maintaining a minimum alveolar concentration (MAC) of 1-1.2, with the patient on assisted mechanical ventilation. Electrocardiographs with HR, NIBP, SpO2, EtCO2, end tidal anaesthetic gas concentration, MAC and temperature were monitored for all patients throughout. Normothermia was ensured by administering humidified anaesthesia gases, warm intravenous and irrigating fluids. Inj. paracetamol 15 mg/kg was given intravenously half an hour before the expected completion of surgery. After the surgery is over, all inhalational anaesthetic agents wree stopped and SGD was removed when the patient was conscious. The patient was shifted to post anaesthesia care unit (PACU) and was allowed orally as soon as the patient is fully awake and asking for feed.
In both the groups, Modified Aldrete Score was used to assess the readiness for discharge from post anaesthesia care unit (PACU) and the time of stay in PACU was noted. All patients wree administered intravenous inj. paracetamol 15 mg/kg 8 hourly. Pain was assessed using FACES score postoperatively at 30 minutes, 1 hour, 3 hours, 6 hours and 24 hours. If the pain score is > or equal 4, inj. diclofenac was given as the rescue analgesic at a dose of (0.3mg/kg) intravenously and noted. Any adverse effects such as nausea and vomiting, hypotension, bradycardia were recorded. If nausea & vomiting occurs, inj. ondansetron (0.15mg/kg) intravenously was administered. Hypotension, defined as systolic blood pressure (SBP) <20% from the baseline, was treated by infusing intravenous fluids. Bradycardia (<20% of the baseline heart rate) was treated with intravenous inj. atropine (0.02 mg/Kg). Severe adverse event (SAE), defined as an adverse event or adverse drug reaction that is associated with aspiration and respiratory distress, death, prolongation of hospitalization, persistent or significant disability or incapacity, or is otherwise life threatening was managed aggressively and was reported to IEC within 24 hours. Patients were monitored at regular intervals in postoperative period, till the discharge criteria are met. The patient was discharged in coordination with orthopaedician according to the following criteria: FACES score of <2 points with or without the use of oral analgesia, normal diet, no need for intravenous fluid, normal body temperature, no evidence of wound infection with normal complete blood count and no serious complications. The total length of postoperative hospital stay in number of days was noted. A record was kept of the patients who have an unplanned visit to hospital within 3 days of discharge.
SUMMARY: To evaluate the postoperative recovery in terms of length of hospital stay in paediatric patients aged 3-10 years undergoing orthopaedic lower limb surgeries by categorizing them into two groups, Enhanced recovery after surgery group and conventional recovery strategy group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 110
Children belonging to age group 3-10 years, scheduled for orthopaedic lower limb surgeries.
1.Patients with prior neuromuscular disease, cerebral palsy, spina bifida, coagulation disorders 2.Patients with inadequate fasting 3.Patients undergoing minor day care procedure.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean (+SD) number of days of postoperative hospital stay with enhanced recovery after surgery (ERAS) protocol compared to conventional recovery strategy in children undergoing orthopaedic lower limb surgeries less than 3 days after discharge
- Secondary Outcome Measures
Name Time Method median FACES score at 30 minutes, 1 hour, 3 hours, 6 hours, 12 hours & 24 hours postoperatively proportion of patients having postoperative nausea & vomiting within 24 hours mean (SD) number of hours of stay in post anaesthesia care unit 2 hours proportion of patients requiring unplanned visit to hospital within 3 days after discharge
Trial Locations
- Locations (1)
Kalawati Saran Childrens Hospital, Lady Hardinge Medical college
🇮🇳Central, DELHI, India
Kalawati Saran Childrens Hospital, Lady Hardinge Medical college🇮🇳Central, DELHI, IndiaDr Erram HarikaPrincipal investigator8328421196akirahchowdary@gmail.com