| CTRI Number |
CTRI/2025/06/088360 [Registered on: 06/06/2025] Trial Registered Prospectively |
| Last Modified On: |
10/06/2025 |
| 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
|
Effectiveness of dexmedetomidine used as an adjuvant with ropivacaine for ultrasound-guided iliohypogastric, illioinguinal and genitofemoral nerve block for inguinal hernia repair surgery |
|
Scientific Title of Study
|
Evaluation of effectiveness of dexmedetomidine used as an adjuvant with ropivacaine 0.5 percent for ultrasound-guided iliohypogastric,ilioinguinal and genitofemoral nerve block as a sole anaesthetic technique in patients undergoing inguinal hernia repair A randomised double blinded controlled study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Idris Ezzy |
| Designation |
Post Graduate Student Anaesthesia |
| Affiliation |
RNT Medical College Udaipur |
| Address |
Department of Anaesthesia, RNT Medical College Udaipur
Udaipur RAJASTHAN 313001 India |
| Phone |
8233936212 |
| Fax |
|
| Email |
idrisezzy110@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Idris Ezzy |
| Designation |
Post Graduate Student Anaesthesia |
| Affiliation |
RNT Medical College Udaipur |
| Address |
Department of Anaesthesia RNT Medical College Udaipur
RAJASTHAN 313001 India |
| Phone |
8233936212 |
| Fax |
|
| Email |
idrisezzy110@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Idris Ezzy |
| Designation |
Post Graduate Student Anaesthesia |
| Affiliation |
RNT Medical College Udaipur |
| Address |
Department of Anaesthesia RNT Medical College Udaipur
RAJASTHAN 313001 India |
| Phone |
8233936212 |
| Fax |
|
| Email |
idrisezzy110@gmail.com |
|
|
Source of Monetary or Material Support
|
| RNT Medical College Udaipur Rajasthan India Pin Code 313001 |
|
|
Primary Sponsor
|
| Name |
RNT Medical College |
| Address |
RNT Medical College Udaipur Rajasthan India pin code 313001 |
| 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 |
| Dr Idris Ezzy |
RNT Medical College |
Department of Anaesthesiology 2nd floor Udaipur RAJASTHAN |
08233936212
idrisezzy110@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RNT Medical College and controller and Attached Hospitals Udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
| Comparator Agent |
Dexmedetomidine, Ropivacaine |
Evaluation of effectiveness of Dexmedetomidine with ropivacaine |
| Intervention |
Regional Anaesthesia |
Ultrasound Guided iliohypogastric, ilioinguinal and genitofemoral nerve block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
1. Patients with American Society of Anaesthesiologist (ASA) Physical Status (PS) 1 to 3
2. Duration of surgery less than 2 hours |
|
| ExclusionCriteria |
| Details |
1. Patients who will not give consent.
2. Infection at the puncture site.
3. Patients with age lesser than 18 years and greater than 65 years
4. Patients with BMI greater than 35 kg per m2
5. Patients with history of allergy to local anaesthetic or dexmedetomidine
6. Patients with resting heart rate lesser than 50 per min.
7. Patients with history of unstable angina or myocardial infarction or complete heart block.
8. Patients with any known severe cardiac, respiratory, renal,or hepatic disease.
9. Patients with history of any psychiatric,neurological disease or seizure disorder.
10. Patients with history of bleeding disorders or deranged coagulation profile.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare Duration of Analgesia in both the groups |
Duration of analgesia is the time postoperatively when patient will demand for rescue analgesia or when patients VAS score is equal to or more than 4 in first 24 hrs. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare Onset of sensory block |
Immediately after block in minutes. |
| To compare duration of sensory block |
Assessed postoperatively in first 24 hrs |
| To compare visual analog scale |
Assessed postoperatively at 1 hr 2 hr 4 hr 6 hr 12 hr 18 hr 25 hr |
| To compare total rescue analgesic consumption |
postoperatively in first 24 hours |
| To compare postoperatively patient satisfaction score |
Assessed after completion of surgery |
| To compare surgeon satisfaction score |
Assessed after completion of surgery |
|
|
Target Sample Size
|
Total Sample Size="66" Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Inguinal hernioplasty is one of the most commonly performed surgical procedures all over the world. Subarachnoid block is routinely used as an anaesthetic technique of choice without much difficulties and adverse outcomes. However, certain comorbid conditions like ischaemic heart disease, valvular heart disease, coagulopathies, cardiomyopathy etc. increase the risk associated with and limits use of neuraxial blockade as a plan of anaesthesia. Bony deformities like kyphosis and scoliosis make subarachnoid block technically difficult and there is also unpredictable spread of local anaesthetic along subarachnoid space. In such scenarios, general anaesthesia remains the sole technique of choice to undergo planned surgery. This makes the patient bear a wide range of shortcomings like delayed recovery, intensive care unit (ICU) admission, mechanical ventilation, prolonged hospital stay with economic burden along with increased risk of morbidity and mortality.
Inguinal hernia block has wide range of advantages over general anaesthesia in patients with a compromised cardiac status and other co-morbidities. It avoids endotracheal intubation, polypharmacy and subsequent delayed recovery. Further, it decreases the need of ventilator support, provides adequate post-operative analgesia with reduced opioid requirement. The period of hospitalisation is also decreased thus reducing the economic burden. Ilioinguinal nerve block (IINB), iliohypogastric nerve block (IHNB) and genital branch of the genitofemoral (GF) nerve blocks completes the anaesthesia and may be used for inguinal hernia repair surgeries.Direct ultrasonographic visualisation of these nerves improves the quality of the block, increases success rate to 95 percent, and reduces the risk for complications. With this background, the present study will be conducted to evaluate the effectiveness of dexmedetomidine used as an adjuvant with ropivacaine 0.5 percent for ultrasound-guided ilioinguinal, iliohypogastric and genital branch of genitofemoral nerve block as a sole anaesthetic technique in patients undergoing inguinal hernia repair. |