| CTRI Number |
CTRI/2025/03/081703 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
03/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
An open labelled comparative study to the assess the effectiveness of sphenopalatine ganglion block given on both sides under ultrasound guidance to provide pain relief in pituitary tumors surgery done through the nose. |
|
Scientific Title of Study
|
EFFECTIVENESS OF BILATERAL ULTRASOUND GUIDED SPHENOPALATINE BLOCK FOR INTRAOPERATIVE ANALGESIA IN ENDOSCOPIC TRANS-NASAL TRANS-SPHENOIDAL RESECTION OF PITUITARY TUMOR UNDER GENERAL ANAESTHESIA: AN OPEN LABEL COMPARATIVE 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 |
Dr Dhanalakshmi R |
| Designation |
Senior resident (DM) |
| Affiliation |
National Institute of Mental Health and Neuro Sciences |
| Address |
Hosur Road, Bengaluru, Karnataka
Bangalore
KARNATAKA
560029
India |
| Phone |
7795102578 |
| Fax |
|
| Email |
dhanalakshmi69852@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gopala Krishna K N |
| Designation |
Professor |
| Affiliation |
National Institute of Mental Health and Neuro Sciences |
| Address |
Hosur Road, Bengaluru, Karnataka
Bangalore
KARNATAKA
560029
India |
| Phone |
9916469626 |
| Fax |
|
| Email |
gops868@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gopala Krishna K N |
| Designation |
Professor |
| Affiliation |
National Institute of Mental Health and Neuro Sciences |
| Address |
Hosur Road, Bengaluru, Karnataka
Bangalore
KARNATAKA
560029
India |
| Phone |
9916469626 |
| Fax |
|
| Email |
gops868@gmail.com |
|
|
Source of Monetary or Material Support
|
| NIMHNAS hospital, Hosur Road, Bengaluru, Karnataka 560029 |
|
|
Primary Sponsor
|
| Name |
NIMHANS hospital |
| Address |
Hosur Road, Bengaluru, Karnataka 560029 |
| 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 Gopala Krishna K N |
NIMHANS hospital |
Professor,
Department of Neuroanaesthesia
And Neurocritical Care
Bangalore
KARNATAKA |
7795102578
gops868@gmil.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE- NIMHANS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D352||Benign neoplasm of pituitary gland, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No block group |
We will compare the outcomes with the patients who are undergoing endoscopic trans-nasal trans-sphenoidal approach for resection of pituitary macroadenoma without administering sphenopalatine ganglion block. |
| Intervention |
Ultrasound guided bilateral sphenopalatine ganglion block |
In patients who are undergoing endoscopic trans-nasal trans-sphenoidal approach for resection of pituitary macroadenoma we will be administering ultrasound guided bilateral sphenopalatine ganglion block to evaluate its effective in providing intra-operative analgesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients scheduled for elective endoscopic Trans-nasal Trans-sphenoidal approach for resection of pituitary tumor will be included in the study. |
|
| ExclusionCriteria |
| Details |
Patients who refuse to give consent, Pre-exisiting Uncontrolled hypertension and diabetes, Coagulopathy or bleeding tendency, Pre-operative Glasgow Coma Scale <15, those who receive dexmedetomidine infusions intraoperatively |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the intra-operative pain (using Analgesia Nociceptive Index) and opioid consumption in patients undergoing Endoscopic Trans-nasal Trans-sphenoidal Resection of pituitary tumors receiving bilateral USG guided SPG block vs no block. |
Data (HR, MAP, SPI, ANIi and ANIm) will be collected every minute for five minutes (T1 – T5) prior to and after the noxious stimuli during surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To compare intra-operative Analgesia Nociception Index (ANI) & Surgical Pleth Index (SPI) with the hemodynamic parameters at various stages of noxious stimulus within the group & between the groups.
2) To compare rescue analgesia between the groups during intraoperative period & up to 48 hours after the surgery.
3) To compare the adverse events between the groups (Intraoperative Bleeding, delayed recovery, PONV)
4) To compare the recovery characteristics at PACU between the groups (modified Aldrette score) & Pain score- NRS |
NSR will be assessed at immediate post-op, 4 hours, 24 hours & 48 hours |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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
|
N/A |
|
Date of First Enrollment (India)
|
17/03/2025 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The trans-nasal trans-sphenoidal (TNTS) resection
of pituitary tumors can lead to significant hemodynamic changes due to brief
but intense pain stimuli during the nasal and sphenoidal stages of the
procedure, as well as during the dissection of the sellar region.
This pain is attributed to the manipulation of sensitive mucosal tissues and
structures within the nasal cavity and sphenoid sinus, which can lead to
substantial discomfort for the patient. Many regional techniques have been used during
resection of pituitary adenoma including infiltration of LA,
bilateral sphenopalatine ganglion block, maxillary nerve block
and bilateral infraorbital nerve
block. This study aims
to compare the intra-operative nociception levels, opioid consumption,
postoperative analgesia and recovery characteristics in patients undergoing
Endoscopic Trans-nasal Trans-sphenoidal Resection of Pituitary Tumors receiving
bilateral ultrasound guided SPG block vs no block. |