| CTRI Number |
CTRI/2018/04/013131 [Registered on: 10/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
24/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Local Anaesthesia for Hernia surgery |
|
Scientific Title of Study
|
Comparison between ropivacaine 0.5% and bupivacaine 0.5% in ilioinguinal-iliohypogastric nerve block for Inguinal Hernia Repair- A prospective randomised double blind study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditi Narang |
| Designation |
Junior Resident |
| Affiliation |
RNT Medical College |
| Address |
Room No. 218, PG Girls Hostel, RNT Medical College,
Udaipur
RAJASTHAN
313001
India |
| Phone |
9587179929 |
| Fax |
|
| Email |
draditinarang@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Indira Kumari |
| Designation |
Senior Professor and Head |
| Affiliation |
Department of Anaesthesiology, RNT Medical College |
| Address |
Flat no. 101, Jai Lakshmi Apartments, Udaipur, Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
|
| Fax |
|
| Email |
dr_ikumari@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aditi Narang |
| Designation |
Junior Resident |
| Affiliation |
Department of Anaesthesiology, RNT Medical College |
| Address |
Department of Anaesthesiology, RNT Medical College
Udaipur
RAJASTHAN
313001
India |
| Phone |
9587179929 |
| Fax |
9587179929 |
| Email |
draditinarang@gmail.com |
|
|
Source of Monetary or Material Support
|
| Deaprtment of Anaesthesiology, RNT Medical College, Udiapur, Rajasthan |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
RNT Medical College |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Aditi Narang |
RNT Medical College |
Department of Anaesthesiology, RNT Medical College, Udaipur
Udaipur
RAJASTHAN |
9587179929
draditinarang@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee, RNT Medical College, Udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
ASA Grade I, II, III, (1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bupivacaine 0.5% with Lignocaine 2% and Ropivacaine 0.5% with Lignocaine 2% |
Ilioinguinal iliohypogastric block given for surgery as well as post operative analgesia |
| Intervention |
Bupivacaine 0.5% with Lignocaine 2% or Ropivacaine 0.5% with Lignocaine 2% |
Ilioinguinal iliohypogastric block given once before surgery and duration noted until patient complaints of pain at Vas more than 3 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
1)ASA Grade I, II and III
2)scheduled for uncomplicated inguinal hernia repair |
|
| ExclusionCriteria |
| Details |
1)Patient refusal
2)Patients with known hypersensitivity to local anaesthetics
3)Patients with ASA grade IV or more
4)Paediatric age group (<18 years)
5)Morbid obesity (BMI >35kg/m2)
6)Complicated hernias such as irreducible, strangulated, incarcerated or recurrent hernia
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of single-puncture technique of local anaesthesia for inguinal hernia repair. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare 0.5% bupivacaine with 0.5% ropivacaine, both in combination with 2% lignocaine-adrenaline regarding efficacy, safety and duration of post-operative analgesia in the patients undergoing unilateral inguinal hernia repair. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/09/2016 |
| Date of Study Completion (India) |
09/09/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
1. Purpose: I. I. To compare 0.5% bupivacaine with 0.5% ropivacaine, both in combination with 2% lignocaine-adrenaline regarding efficacy, safety and duration of post-operative analgesia in the patients undergoing unilateral inguinal hernia repair. II. To document complications, if any. Results were as follows: 1. The mean age of patients in our study was 48.6±15.56 years in Group LB and 46.48±14.03 years in Group LR. 2. The mean weight (kg) of the patients in Group LB was 62.91±6.89 and in Group LR was 61.71±6.44. 3. In Group LB, 25 (71.42%) patients belonged to ASA grade I, 10 (28.57%) belonged to ASA grade II and none to ASA grade III. While in Group LR, 27 (77.14%) patients were of ASA grade I, 8 (22.85%) were of ASA grade II and none in ASA grade III. 4. In Group LB, 13 (37.14%) patients had hernia on the right side and 22 (62.85%) on the left side as compared to Group LR where 17 (48.57%) patients had hernia on the right side and 18 (51.42%) on the left side. 5. In group LB, the onset was earlier (10.15±1.49 min) as compared to Group LR (11.4±1.71 min). 6. Duration of surgery in Group LB was 59.34±10.90 min and in Group LR was 61.22±11.02 min. 7. Preoperative VAS score was less in group LB (0.64±0.54) as compared to Group LR (0.77±0.49). VAS at the time of shifting was found to be more in Group LB (0.94±0.53) than in Group LR (0.91±0.50) patients. 8. Seventeen (48.57%) patients in Group LR required infiltration of sac as compared to three (8.57%) in Group LB. 9. Duration of analgesia was significantly longer in Group LR (481.71±70.52 min) as compared to Group LB (236.57±35.5 min). 10. There was no statistically significant difference in haemodynamic parameters of HR, SBP, DBP and MAP of two groups at any given time. 11. No complications related to the procedure or drugs were observed in our study. |