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CTRI Number  CTRI/2023/07/055154 [Registered on: 13/07/2023] Trial Registered Prospectively
Last Modified On: 20/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   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 
Scientific Title of Study   Enhanced recovery after surgery (ERAS) protocol versus conventional recovery strategy for evaluation of postoperative recovery in children undergoing orthopaedic lower limb surgeries: A randomized controlled trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Erram Harika 
Designation  Post Graduate First year resident 
Affiliation  Lady hardinge medical college 
Address  Lady Hardinge Medical College and associated hospitals, Shaheed Bhagat Singh Road, Connaught Place, DIZ Area New Delhi, Delhi 110001 India

Central
DELHI
110001
India 
Phone  8328421196  
Fax    
Email  akirahchowdary@gail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Preeti Goyal Varshney 
Designation  Associate Professor 
Affiliation  Lady hardinge medical college 
Address  Lady Hardinge Medical College and associated hospitals, Shaheed Bhagat Singh Road, Connaught Place, DIZ Area New Delhi, Delhi 110001 India

Central
DELHI
110001
India 
Phone  9999353519  
Fax    
Email  doc_1998@rediff.com  
 
Details of Contact Person
Public Query
 
Name  Erram Harika 
Designation  Post Graduate First year resident 
Affiliation  Lady hardinge medical college 
Address  Lady Hardinge Medical College and associated hospitals, Shaheed Bhagat Singh Road, Connaught Place, DIZ Area New Delhi, Delhi 110001 India

Central
DELHI
110001
India 
Phone  8328421196  
Fax    
Email  akirahchowdary@gail.com  
 
Source of Monetary or Material Support  
Lady Hardinge Medical College and associated hospitals 
 
Primary Sponsor  
Name  Lady Hardinge Medical College and associated hospitals 
Address  Lady Hardinge Medical College and associated hospitals, Shaheed Bhagat Singh Road, Connaught Place, DIZ Area New Delhi, Delhi 110001, India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Erram Harika  Kalawati Saran Childrens Hospital, Lady Hardinge Medical college  Paediatric OT, Third floor, Department of Anaesthesia, Connaught circus, Bangla sahib road, DIZ area, connaught place, new delhi, 110001
Central
DELHI 
8328421196

akirahchowdary@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, LHMC & associated hospitals,New Delhi-110001  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Conventional group  Written informed consent, Fasting according to ASA guidelines, General anaesthesia with opioids Premedication: Intravenous injection (inj.) ondansetron (0.15mg/Kg) and inj. fentanyl 2 µg/Kg. Patients will be pre-oxygenated with 100% oxygen for 3 minutes and anaesthesia will be induced intravenously with slow administration of inj. propofol 2mg/Kg. After confirming adequate depth of anaesthesia, a weight appropriate supraglottic airway device (SGD) will be placed. Adequate ventilation will be ensured and patient will be 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 will be administered, Use of body warmer to maintain normothermia, postoperative resumption of oral feeds-4 hours after surgery 
Comparator Agent  ERAS group  Education and illustration in addition to written informed consent, Fasting according to ASA guidelines, intake of clear liquids will be ensured until 2 hours before surgery, Opioid free anaesthesia Premedication: Intravenous injection (inj.) ondansetron (0.15mg/Kg) and inj. ketamine 1 mg/Kg. Patients will be pre-oxygenated with 100% oxygen for 3 minutes and anaesthesia will be induced intravenously with slow administration of inj. propofol 2 mg/Kg. After confirming adequate depth of anaesthesia, a weight appropriate SGD will be placed. Adequate ventilation will be ensured and patient will be 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 will be administered., To maintain normothermia-Use of body warmer, humidified anaesthetic gases, administering warm intravenous fluid, using warm irrigation fluids, postoperative resumption of oral feeds when the patient is fully awake and asking for feed  
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Children belonging to age group 3-10 years, scheduled for orthopaedic lower limb surgeries  
 
ExclusionCriteria 
Details  1. Patients with prior neuromuscular disease, cerebral palsy, spina bifida, coagulation disorders
2. Patients with inadequate fasting
3. Patients undergoing minor day care procedure
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
mean (SD) number of hours of stay in post anaesthesia care unit  2 hours 
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 
proportion of patients requiring unplanned visit to hospital  within 3 days after discharge 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
Final Enrollment numbers achieved (Total)= "110"
Final Enrollment numbers achieved (India)="110" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   24/07/2023 
Date of Study Completion (India) 31/10/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="3"
Days="18" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

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.

 
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