| CTRI Number |
CTRI/2019/07/020216 [Registered on: 16/07/2019] Trial Registered Prospectively |
| Last Modified On: |
09/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
THE EFFICACY OF ILIOINGUINAL AND ILIOHYPOGASTRIC NERVE BLOCK FOR POSTOPERATIVE PAIN RELIEF IN INGUINAL HERNIA SURGERY UNDER SPINAL ANESTHESIA |
|
Scientific Title of Study
|
ULTRASOUND GUIDED ILIOINGUINAL AND ILIOHYPOGASTRIC NERVE BLOCK FOR POSTOPERATIVE PAIN RELIEF IN PATIENTS UNDERGOING INGUINAL HERNIA SURGERY UNDER SPINAL ANAESTHESIA-A COMPARATIVE STUDY |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr VASANTHAGEETHAN MD |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
GOVERNMENT MOHAN KUMARAMANGALAM MEDICAL COLLEGE ,SALEM |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
GOVERNMENT MOHAN KUMARAMANGALAM MEDICAL COLLEGE,SALEM
Salem
TAMIL NADU
636001
India |
| Phone |
9944269790 |
| Fax |
|
| Email |
drgeethan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ARUNACHALAM MD DNB |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
GOVERNMENT MOHAN KUMARAMANGALAM MEDICAL COLLEGE,SALEM |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,
GOVERNMENT MOHAN KUMARAMANGALAM MEDICAL COLLEGE,SALEM
Salem
TAMIL NADU
636001
India |
| Phone |
9965520752 |
| Fax |
|
| Email |
drrarunc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MOUNRAJ A |
| Designation |
POST GRADUATE |
| Affiliation |
GOVERNMENT MOHAN KUMARAMANGALM MEDICAL COLLEGE,SALEM |
| Address |
19,POST GRADUATE MENS HOSTEL,
GOVERNMENT MOHAN KUMARAMANGALAM MEDICAL COLLEGE,SALEM
DEPARTMENT OF ANAESTHESIOLOGY,GOVERNMENT MOHAN KUMARAMANGALAM MEDICAL COLLEGE,SALEM
Salem
TAMIL NADU
636001
India |
| Phone |
9965323809 |
| Fax |
|
| Email |
drmoun05@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT MOHAN KUMARAMANGALAM MEDICAL COLLEGE,SALEM |
|
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Primary Sponsor
|
| Name |
Dr MOUNRAJ A |
| Address |
POST GRADUATE,DEPARTMENT OF ANAESTHESIOLOGY,GOVERNMENT MOHAN KUMARAMANGAL MEDICAL COLLEGE,SALEM |
| Type of Sponsor |
Other [i will spent for logistics to complete my dissertation without help from other sources] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr MOUNRAJ A |
government mohan kumaramangalam medical college,salem |
Department of General surgery
New Surgical Block Theatre
NSB operating theatre no 1,2,3&4
Salem
TAMIL NADU |
9965323809
drmoun05@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE( GMKMC@H/4341/IEC/01/2017-53 |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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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 |
In inguinal hernia surgery patients post operative pain is intervened with ilioiguinal and iliohypogastric nerve block using 0.25% bupivaccaine and 0.9% normal saline.the efficacy of ilioinguinal and iliohypogastric nerve block in reducing postoperative analgesic comsumption is compared in this study. |
GROUP B: 17.5MG OF 0.5% BUPIVACCAINE UESD IN SUBARACHNOID BLOCK+ 20ML OF 0.25%% BUPIVACCAINE AS BLOCK DRUG FOR ILIOINGUINAL AND ILIOHYPOGASTRIC NERVE BLOCK...GROUP C: 17.5MG OF 0.5% BUPIVACCAINE USED IN SUBARACHNOID BLOCK+ 20ML OF 0.9% NORMAL SALINE USED IN ILIOINGUINAL AND ILIOHYPOGASTRIC NERVE BLOCK. POSTOERATIVE PAIN SCORE(VAS),TIME INTERVAL UNTIL FIRST DOSE OF ANALGESIC AND TOTAL ANALGESIC REQUIREMENT IN FIRST 24 HOURS ARE COMPARED |
| Comparator Agent |
The efficacy and effectiveness of ilioinguinal and iliohypogastric nerve block in reducing post operative pain score and their reduction of total analgesic dose consumption are compared with parentral analgesics. |
The efficacy and effectiveness of ilioinguinal and iliohypogastric nerve block in reducing post operative pain score and their reduction of total analgesic dose consumption are compared with parentral analgesics. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)PERSONS POSTED FOR ELECTIVE UNCOMPLICATED INGUINAL HERNIA SURGERY
2)AGED 18 TO 70 YEARS
2)PERSONS BELONGING TO AMERICAN SOCIETY OF ANAESTHESIOLOGISTS PHYSICAL STATUS CLASS I & II |
|
| ExclusionCriteria |
| Details |
1)PATIENTS REFUSAL
2)AGE LESS THAN 18 AND MORE THAN 70 YEARS
3)LARGE AND IRREDUCIBLE HERNIA ,BILATERAL HERNIA
4)RECURRENT INGUINAL HERNIA PATIENTS
5)BMI >35KG/m2
6)EMERGENCY SURGERIES
7)SKIN INFECTION AT PUNCTURE SITE
8)ALLERGY TO LOCAL ANAESTHETICS
9)PREOPERATIVE OPIOID AND NON STEROIDAL DRUG TREATMENT FOR CHRONIC PAIN TREATMENT
10)SURGERIES LASTING MORE THAN 2 HOURS
11)Addictives added to spinal anaesthesia
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
1)POST OPERATIVE PAIN SCORE(VISUAL ANALOG SCORE-VAS)AT 30MIN,1HR,4HR,8HR,12HR,16HR,20HR AND AT 24HR POST OPERATIVELY
2)TIME INTERVAL UNTIL FIRST DOSE OF ANALGESIC
3)ANALGESIC REGUIREMENT IN THE POST OPERATIVE PERIOD(FIRST 24 HOURS) |
1)POST OPERATIVE PAIN SCORE(VISUAL ANALOG SCORE-VAS)AT 30MIN,1HR,4HR,8HR,12HR,16HR,20HR AND AT 24HR POST OPERATIVELY
2)TIME INTERVAL UNTIL FIRST DOSE OF ANALGESIC
3)ANALGESIC REGUIREMENT IN THE POST OPERATIVE PERIOD(FIRST 24 HOURS) |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1)Total analgesic consumption in first 24 hours
2)RECORDING OF COMPLICATION IF ANY( ALLERGY, INFECTION, TECHNICAL FAILURE)in first 24 hours |
1)Total analgesic consumption in first 24 hours
2)RECORDING OF COMPLICATIONS IF ANY( ALLERGY, INFECTION, TECHNICAL FAILURE)in first 24 hours |
|
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Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/08/2019 |
| Date of Study Completion (India) |
10/03/2020 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
- What additional supporting information will be shared?
- Who will be able to view these files?
- For what types of analyses will this data be available?
- By what mechanism will data be made available?
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information -
|
Brief Summary
Modification(s)
|
Inguinal hernia is one of the most common surgical procedure.Immediate post operative pain is an important issue that can delay ambulation and return of gastrointestinal motility,therefore delaying hospital discharge. Pain after herniorrhapy which can affect upto 50% of patients,this picture seems to be related to inadequate postoperative pain treatment,which makes control of postoperative pain is fundamental. opioids, non steroidal anti inflammatory drugs and analgesics are commonly used to treat postoperative pain,but they are associated with several undesiarable side effects.management of postoperative pain is often unsatisfactory.the drugs not seem to be completely effective on preventing and treating postoperative pain. ultrasound guided ilioinguinal and iliohypogastric nerve block presents a novel anaesthetic technique. The effectiveness of ultrasound guided ilioinguinal and iliohypogastric nerve block for relieving post operative pain following inguinal hernia surgeries is going to be evaluated in this study. |