| CTRI Number |
CTRI/2025/09/095254 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To check a safety protocol to decrease Epidural Anaesthesia related complications in patients going for knee replacement surgeries: A Randomized Trial |
|
Scientific Title of Study
|
To evaluate a safety protocol to reduce Epidural Anaesthesia related complications in patients posted for knee replacement surgeries: A Randomized 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 Yuvraj Walia |
| Designation |
PG Student |
| Affiliation |
Adesh Institute Of Medical Sciences And Research, Bathinda(AIMSR), Punjab |
| Address |
Department of Anaesthesiology and Intensive Care, Adesh Institute Of Medical Sciences And Research, Bathinda, Punjab
Bathinda
PUNJAB
151001
India |
| Phone |
9781410012 |
| Fax |
|
| Email |
yuvraj.walia0798@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sham Sunder Goyal |
| Designation |
Associate Professor, Department Of Anaesthesiology And Intensive Care, AIMSR, Bathinda |
| Affiliation |
Adesh Institute Of Medical Sciences And Research, Bathinda(AIMSR), Punjab |
| Address |
Department Of Anaesthesiology And Intensive Care, Adesh Institute Of Medical Sciences And Research, Bathinda, Punjab
Bathinda
PUNJAB
151001
India |
| Phone |
8146832590 |
| Fax |
|
| Email |
drshamgoyal@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sham Sunder Goyal |
| Designation |
Associate Professor, Department Of Anaesthesiology And Intensive Care, AIMSR, Bathinda |
| Affiliation |
Adesh Institute Of Medical Sciences And Research, Bathinda(AIMSR), Punjab |
| Address |
Department Of Anaesthesiology And Intensive Care, Adesh Institute Of Medical Sciences And Research, Bathinda, Punjab
PUNJAB
151001
India |
| Phone |
8146832590 |
| Fax |
|
| Email |
drshamgoyal@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Adesh Institute Of Medical Sciences And Research (AIMSR), Bathinda, Punjab, India (151001) |
|
|
Primary Sponsor
|
| Name |
Adesh Institute Of Medical Sciences And Research Bathinda Punjab India |
| Address |
Adesh Institute Of Medical Sciences And Research(AIMSR), Bathinda, Punjab, India (151001) |
| 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 Yuvraj Walia |
Adesh Institute Of Medical Sciences And Research (AIMSR) |
Department of Anaesthesiology and Intensive Care
Bathinda
PUNJAB |
9781410012
yuvraj.walia0798@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Adesh University |
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 |
| Comparator Agent |
1 ml Normal Saline |
Here, instead of giving 1 ml (0.2 mg) Glycopyrrolate, we’ll give 1 ml Normal Saline as placebo. |
| Intervention |
To evaluate a safety protocol of preloading of 10 ml /kg body weight of
crystalloids, prophylactic use of intravenous glycopyrrolate and also pre- instillation
of normal saline (5 ml) into the epidural space to prevent epidural placement related
complications. |
(a) Pre-loading of the patient with IV crystalloids 10 ml/kg before the procedure.
(b) Prophylactic IV Glycopyrrolate 0.2 mg before the insertion of epidural catheter.
(c) Pre- instillation of epidural space with 5 ml of normal saline before insertion of epidural catheter. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-65 years
All genders
ASA Grade I or II
Body weight 50-90 kg
Patients undergoing elective knee replacement surgeries |
|
| ExclusionCriteria |
| Details |
Spinal deformities or anatomical abnormalities
Contraindications to spinal/epidural anaesthesia
Abnormal hepatic, renal, or hematological parameters
Patient refusal for regional anaesthesia
Known allergy to study medications |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate a safety protocol of preloading of 10 ml /kg body weight of crystalloids, prophylactic use of intravenous glycopyrrolate and also pre- instillation of normal saline (5 ml) into the epidural space to prevent epidural placement related complications. |
According to Likerts Scale, easy catheter insertion is defined as if consultant who secures epidural catheter says that he/she agree (4) or strongly agree (5) that it is an easy and smooth insertion of epidural catheter.
Difficult insertion will be defined as if consultant who secures epidural catheter says that he/she strongly disagree (1) or disagree (2) or undecided (3) about easiness of insertion of epidural catheter. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the incidence of vasovagal attacks during epidural insertion. |
|
| To find out the associated complications related to epidural and the incidence of intravascular placement of epidural catheter. |
|
| To find out the uniformity of epidural drug spread/two segment regression & requirement of rescue analgesia. |
|
| To check the hemodynamic response. |
T0- At the start of procedure
T5- 5 mins
T10- 10 mins
T15- 15 mins
TN |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
10/10/2025 |
| 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="1"
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
|
Epidural anaesthesia and analgesia has emerged as the gold standard regional anaesthetic technique for lower limb surgeries, particularly joint replacement procedures and major abdominal surgeries. With recent advances in anaesthetic practice, epidural anaesthesia has become a key modality for perioperative analgesia, offering superior pain control, reduced opioid requirements, enhanced patient tolerance, early mobilization, and cost-effectiveness compared to conventional approaches.
However, epidural catheter placement is not without complications. The most frequently encountered complications include hypotension, paresthesias, inadvertent vascular or subarachnoid cannulation, catheter insertion failure, post-dural puncture headaches, non-uniform drug distribution, epidural hematomas, and vasovagal reactions. Among these, vasovagal attacks represent a particularly concerning complication that can manifest as sudden cardiovascular collapse with profound bradycardia and hypotension.
Vasovagal reactions during epidural procedures occur with an incidence ranging from 0-4% in general populations, with higher rates of 3.5% reported for epidural steroid injections specifically (Malave & Vrooman, 2022). These episodes can present with a spectrum of symptoms including diaphoresis, nausea, vomiting, dizziness, palpitations, visual disturbances, and in severe cases, sudden cardiac arrest.
Three types of vasovagal responses have been described in the literature: a cardio inhibitory form (HR < 40 bpm), vasodepressor form (SBP < 80 mmHg or decrease by >30% without significant HR reduction), or mixed form (HR < 40 bpm and SBP < 80 mmHg or decrease by >30%) .
The literature shows that preloading of crystalloids prevents hypotension induced by spinal /epidural anesthesia,may help to prevent vasovagal reaction.
There are studies that tested that pre distending the epidural space with saline 5ml before epidural catheter insertion can help to prevent intravascular placement by pushing blood vessels and other anatomical structures away from the catheter path, potentially ease in insertion of epidural catheter and reducing its intravascular placement.
The drug glycopyrrolate a quaternary ammonium compound, another antimuscarinic drug, has similar pharmacological effect like atropine but more prolonged action with minimal CNS side effects (as it does not crosses the Blood Brain Barrier).
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