| CTRI Number |
CTRI/2025/08/092791 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
11/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Making Nerve Blocks Better: Comparing 10 Percentage Dextrose and Normal Saline as Diluents for Nerve Blocks Under Ultrasound Guidance |
|
Scientific Title of Study
|
Pilot Study: Comparing the Duration of Action in Ultrasound-Guided Nerve Blocks with 10 Percentage Dextrose Versus Normal Saline Addition |
| 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 Prasanna Vadhanan |
| Designation |
HOD |
| Affiliation |
Vinayaka Missions Medical College and Hospital, Karaikal |
| Address |
Room number 1, Department of Anaesthesiology, Vinayaka Missions Medical College and Hospital, Keezhakasakudymedu, Kottuchery post, Karaikal, Puducherry 609609
Karaikal
PONDICHERRY
609609
India |
| Phone |
9486489690 |
| Fax |
|
| Email |
vadhanan.prasanna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karthik Sarma Akella |
| Designation |
Senior Resident |
| Affiliation |
Vinayaka Missions Medical College and Hospital |
| Address |
Plot no 25, Manju Anuradha Enclave, Malkajgiri, Secunderabad, Hyderabad-500047
Hyderabad
TELANGANA
500047
India |
| Phone |
9730069543 |
| Fax |
|
| Email |
KarthikSarma.Akella@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nithanthini B |
| Designation |
Junior Resident/Post Graduate |
| Affiliation |
Vinayaka Missions Medical College and Hospital |
| Address |
Room no 2, Department of Anaesthesiology,Vinayaka Missions Medical College and Hospital, Keezhakasakudymedu, Kottuchery post, Karaikal, Puducherry 609609
Karaikal
PONDICHERRY
609609
India |
| Phone |
9585011370 |
| Fax |
|
| Email |
bnithanthinikamacshi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Medical College and Hospital |
| Address |
Keezhakasakudymedu, Kottuchery post, Karaikal, Puducherry- 609609 |
| Type of Sponsor |
Private 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 Nithanthini B |
Vinayaka Missions Medical College And Hospital |
Department of Anaesthesiology, Vinayaka Missions Medical College and Hospital,Keezhakasakudymedu,Kottuchery post, Karaikal,Puducherry 609609
Karaikal
PONDICHERRY |
9585011370
bnithanthinikamacshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A |
Patients receive Nerve BLock with Injection Lignocaine with Adrenaline 2 Percentage (12ml) along with injection Bupivacaine 0.5 Percentage (15ml) with 10 Percentage Dextrose(10ml) as Diluent before the surgery |
| Comparator Agent |
Group B |
Patients recieve Nerve Block with Injection Lignocaine with Adrenaline 2 Percentage (12ml) along with injection Bupivacaine 0.5 Percentage (15ml) with 0.9 Percentage Normal Saline (10ml) as diluent before the surgery |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) ASA physical status 1,2 and 3.
2) Patient undergoing orthopedic limb surgeries both upper limb and lower limb.
3) Patients undergoing surgical or orthopedic wound debridement.
4) Patients undergoing split skin graft over the extremities |
|
| ExclusionCriteria |
| Details |
1) Absolute contraindications to the use of peripheral nerve blocks such as allergy to local anesthetics,
inability to cooperate,
patient refusal.
2) Active infection at the injection site.
3) Pre-existing neural deficits along the distribution of the block.
4) Patients with coagulopathies.
5) Patients on antithrombotic drugs. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the duration of action in ultrasound-guided nerve blocks when using 10% dextrose as an additive versus normal saline |
3 mins, 6 mins, 9 mins, 12 mins, 15 mins, 18 mins, 20 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To evaluate the onset of the analgesic effect in ultrasound-guided nerve blocks with 10% dextrose compared to normal saline.
2) To analyze the safety profile of the nerve blocks with 10% dextrose versus normal saline, considering any adverse events or complications.
|
3 mins, 6 mins, 9 mins, 12 mins, 15 mins, 18 mins, 20 mins |
|
|
Target Sample Size
|
Total Sample Size="14"
Sample Size from India="14"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
25/08/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 pilot study investigates whether adding 10% dextrose to local anesthetics in ultrasound-guided peripheral nerve blocks offers longer and more effective pain relief compared to normal saline. Conducted at Vinayaka Missions Medical College & Hospital, Karaikal, over six months, the randomized study will include 14 patients divided into two groups of seven each. Group A will receive a combination of local anesthetics with 10% dextrose, while Group B will receive the same anesthetics with normal saline. The study focused on comparing the duration of anesthesia, onset of pain relief, patient satisfaction, and safety profiles between the two groups. Sensory and motor blocks were assessed every 2–3 minutes post-injection, and pain levels were recorded using the Visual Analogue Scale. The study included patients aged 10–80 years undergoing orthopedic or wound-related limb surgeries, with exclusion criteria such as ASA IV status, allergies to anesthetics, and coagulopathies. Results aim to determine if 10% dextrose can enhance block duration, reduce the need for rescue analgesia, and improve overall patient outcomes in clinical anesthesia practice. |