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CTRI Number  CTRI/2019/03/017888 [Registered on: 01/03/2019] Trial Registered Prospectively
Last Modified On: 24/10/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To Compare different concentrations of Ropivacaine for post operative pain relief in inguinal hernia repair  
Scientific Title of Study   “Comparison of two different concentrations of Ropivacaine 0.25% and 0.5% for post operative analgesia in inguinal hernia repair-A Prospective Randomized Study” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1227-7642  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr M Niranjan Reddy 
Designation  Post Graduate 
Affiliation  Teerthanker Mahaveer Medical college 
Address  2nd floor, Department of Anaesthesia Teerthanker Mahaveer Medical college Bagadpur, delhi road, Moradabad UP-244001

Moradabad
UTTAR PRADESH
244001
India 
Phone  8522838456  
Fax    
Email  tillureddy1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mukesh Kumar Prasad 
Designation  Associate Professor 
Affiliation  Teerthanker Mahaveer Medical college 
Address  2nd floor, Department of Anaesthesia Teerthanker Mahaveer Medical college Bagadpur, delhi road, Moradabad UP-244001

Moradabad
UTTAR PRADESH
244001
India 
Phone  9837624543  
Fax    
Email  mukeshkumar2002@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr M Niranjan Reddy 
Designation  Post Graduate 
Affiliation  Teerthanker Mahaveer Medical college 
Address  2nd floor, Department of Anaesthesia Teerthanker Mahaveer Medical college Bagadpur, delhi road, Moradabad UP-244001


UTTAR PRADESH
244001
India 
Phone  8522838456  
Fax    
Email  tillureddy1@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Department of Anaesthesia Teerthanker Mahaveer Hospital 
Address  2nd floor, Department of Anaesthesia Teerthanker Mahaveer Medical college Bagadpur, delhi road, Moradabad UP-244001  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Dr Mukesh Kumar Prasad  2nd floor, Department of Anaesthesia Teerthanker Mahaveer Medical college Bagadpur, delhi road, Moradabad UP-244001  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr M Niranjan Reddy  Teerthanker Mahaveer Medical college and research centre  Room no: 1 surgery Operation theatre Department of Anaesthesia UP-244001
Moradabad
UTTAR PRADESH 
8522838456

tillureddy1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Local Infiltration  Study drug of 20ml Ropivacaine will be administered subcutaneously at the time of skin closure on both sides of incision. 
Comparator Agent  Ropivacaine 0.25%  To compare 0.25% and 0.5% Ropivacaine for postoperative analgesia in Inguinal Hernia repair. 
Comparator Agent  ROPIVACAINE 0.5%  To compare 0.25% and 0.5% Ropivacaine for postoperative analgesia in Inguinal Hernia repair.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. American Society of Anaesthesiologists (ASA) grade I & II patients
2. Patients with BMI 18.5-22.9 kg/m2
3. 18 - 60 years
 
 
ExclusionCriteria 
Details  1. Patients refusal
2. Hypersensitivity to local anesthetics
3. BMI > 25 kg/m2
4. Chronic analgesic therapy
5. Giant inguinoscrotal hernias
6. Any absolute contraindications to spinal anaesthesia
• Hernia with hydrocele
• Any surgery extending more than 100 minutes. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Duration of postoperative analgesia for two different concentrations of Ropivacaine.  18 months 
 
Secondary Outcome  
Outcome  TimePoints 
Hemodynamic Parameters and side effects  18 months 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
Final Enrollment numbers achieved (Total)= "192"
Final Enrollment numbers achieved (India)="192" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   05/03/2019 
Date of Study Completion (India) 27/02/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
1. Saeed M, Andrabi WI, Rabbani S, Zahur S, Mahmood K, Andrabi S.I, et al. The impact of preemptive ropivacaine in inguinal hernioplasty. A randomized controlled trial. Int J Surg. 2015;13:76-9. 2. Suman LG, Prasanna B. Postoperative analgesia after inguinal hernia repair comparing bupivacaine with Ropivacaine. Anaesthesia essays and researches. 2016;10:71-6. 3. Parekh SB, Parikh SS, Patel H, Mehta M. A prospective comparative observational study of clinical efficacy of isobaric ropivacaine 0.75% with of isobaric bupivacaine 0.5% intrathecally in elective inguinal hernia repair surgeries. Anesth Essays Res 2017;11:561-6. 4. Zavadinack Netto M, Prado Filho OR, Bandeira COP, Sales KPF, Camiloti TA. Herniorrafia inguinal: anestesia local ou regional? Acta Scientiarum 22(2);621-623, 2000. 5. Ribeiro FAS. Cirurgia Ambulatorial. In: Saad Junior R, Salles ROR, Carvalho WR, Maia AM, editores. Tratado de Cirurgia do CBC. São Paulo: Atheneu; 2009. p.1467-81.  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

To Compare two different concentrations of Ropivacaine 0.25% and 0.5%  for post operative analgesia in inguinal hernia repair.

 

Randomisation will be performed using chit and box method and the patients will be divided into two groups.

Group A - 20ml of 0.25% Ropivacaine subcutaneously, 

Group B - 20ml of 0.5% Ropivacaine subcutaneously

SKIN INFILTRATIONStudy drug of 20ml Ropivacaine will be administered subcutaneously at the time of skin closure on both sides of incision by double blind technique.

•      After the surgery, the patients will be shifted to the recovery room and standard monitoring like ECG, NIBP, SpO2 will be attached .

•      Patients will be observed in the recovery room for 60min and will be assessed every 15 min. Postoperative Hemodynamic parameters- H.R, SPO2, SBP,DBP,MAP will be noted.

•      Postoperatively, the pain on rest, pain on coughing and pain on movements will be assessed using VAS score immediately after the surgery and then every 2 hours to 12 hours.

•      The time of first request for rescue analgesia will be noted and rescue analgesia will be provided with Inj.Tramadol 1mg/kg iv on demand or when VAS score more than 4. Total dose of rescue analgesia given in 12 hours will be recorded.

•      Side effects such as headache, nausea, vomiting, allergic reactions and convulsions will be looked for.

This prospective randomized clinical study compared Ropivacaine 0.25% and 0.5% for post-operative analgesia for the repair of inguinal hernia. There was an almost uniform distribution of the males and females among 2 groups. The mean age of the subjects in the 2 groups was 43.44±10.74 years and 41.63±11.55 years respectively.

No significant difference in heart rate, Systolic blood pressure, Diastolic blood pressure, Mean blood pressure and SpO2 between 2 groups. The mean VAS score (at Rest) at 8 hours was significantly more among GROUP A (0.50%) compared to GROUP B (0.25%). The mean VAS score (at Coughing) at 6, 8 and 10 hours was significantly more among GROUP B (0.25%) compared to GROUP A (0.50%). The mean VAS score (at movement) at 8, 10 and 12 hours was significantly more among GROUP B (0.25%) compared to GROUP A (0.50%).

Inguinal hernia surgery can be well undertaken in local infiltration technique. The field block technique meets all the requirements needed for the surgery, like adequate analgesia, enough relaxation, good haemodynamic stability, minimal side effects and in addition longer post-operative pain relief. It is the well suited technique for day care surgery. Ropivacaine 0.5% provided good quality  anesthesia for inguinal surgery compared to 0.25% Ropivacaine.

Ropivacaine as an anesthetic in ingui­nal hernia repair for elderly patients is safe and effective in pain reduction, with very few adverse reactions. Ropivacaine is optimally effective regarding heart rate reduction, arterial pressure, or perceived pain by patients at the concentration of 0.5% with least side effects.

1.          Saeed M, Andrabi WI, Rabbani S, Zahur S, Mahmood K, Andrabi S.I, et al. The impact of preemptive ropivacaine in inguinal hernioplasty. A randomized controlled trial. Int J Surg. 2015;13:76-9.

2.          Suman LG, Prasanna B. Postoperative analgesia after inguinal hernia repair comparing bupivacaine with Ropivacaine. Anaesthesia essays and researches. 2016;10:71-6.

3.          Parekh SB, Parikh SS, Patel H, Mehta M. A prospective comparative observational study of clinical efficacy of isobaric ropivacaine 0.75% with of isobaric bupivacaine 0.5% intrathecally in elective inguinal hernia repair surgeries. Anesth Essays Res 2017;11:561-6.

4.          Zavadinack Netto M, Prado Filho OR, Bandeira COP, Sales KPF, Camiloti TA. Herniorrafia inguinal: anestesia local ou regional? Acta Scientiarum 22(2);621-623, 2000.

5.          Ribeiro FAS. Cirurgia Ambulatorial. In: Saad Junior R, Salles ROR, Carvalho WR, Maia AM, editores. Tratado de Cirurgia do CBC. São Paulo: Atheneu; 2009. p.1467-81.


 
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