| CTRI Number |
CTRI/2026/02/102709 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to assess the Effect of Lingual nerve block on Heart rate and Blood pressure during Tongue cancer Surgery |
|
Scientific Title of Study
|
Attenuation of Hemodynamic Response to Surgical Stimulation with Lingual Nerve Block in Carcinoma Tongue Surgery under General Anesthesia: 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 |
Dr Amita Jansari |
| Designation |
Assistant Professor |
| Affiliation |
Gujarat Cancer and Research Institute |
| Address |
Department of Anesthesia, Gujarat Cancer and Research Institute, Civil Hospital, Asarwa, Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9879778701 |
| Fax |
|
| Email |
amita.jansari@gcriindia.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amita Jansari |
| Designation |
Assistant Professor |
| Affiliation |
Gujarat Cancer and Research Institute |
| Address |
Department of Anesthesia, Gujarat Cancer and Research Institute, Civil Hospital, Asarwa, Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9879778701 |
| Fax |
|
| Email |
amita.jansari@gcriindia.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amita Jansari |
| Designation |
Assistant Professor |
| Affiliation |
Gujarat Cancer and Research Institute |
| Address |
Department of Anesthesia, Gujarat Cancer and Research Institute, Civil Hospital, Asarwa, Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9879778701 |
| Fax |
|
| Email |
amita.jansari@gcriindia.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Amita Jansari |
| Address |
Gujarat Cancer and Research Institute, Civil Hospital, Asarwa, Ahmedabad-380016 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Amita Jansari |
Gujarat Cancer and Research Institute |
Department of Anesthesia, Gujarat Cancer and Research Institute, Civil Hospital, Asarwa, Ahmedabad
Ahmadabad
GUJARAT |
9879778701
amita.jansari@gcriindia.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GCRI/GCS ETHICS COMMITTEE-BHR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fentanyl and Sevoflurane requirement |
tongue resection |
| Intervention |
Lingual Nerve Block |
Tongue Resection |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) ASA I and II Physical Status
2) Tumour Staging- T 1-2
3) Elective Carcinoma Tongue Surgery with or without neck dissection under general anesthesia
4) Provided Informed Consent |
|
| ExclusionCriteria |
| Details |
1) Coagulopathy
2) Allergy to local anesthetics
3) Preexisting cranial nerve neuropathy
4) Refusal to participate |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes to heart rate and mean arterial pressure to surgical stimulation during tongue resection |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total intraoperative opioid (fentanyl)consumption |
1 year |
| Sevoflurane MAC requirement |
1 year |
| incidence of adverse events or complications related to lingual nerve block |
1 year |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/02/2026 |
| Date of Study Completion (India) |
10/08/2026 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a prospective, randomized, controlled study comparing hemodynamic response to surgical stimulation with Lingual Nerve Block in carcinoma tongue surgery under general anesthesia. Primary outcome measure the significant attenuation of heart rate and mean arterial pressure changes in the Lingual nerve block during tongue resection. Secondary outcome measure reduced intraoperative opioid and anesthetic requirement while lingual nerve block given and no significant block-related complications. |