| CTRI Number |
CTRI/2026/02/104396 [Registered on: 20/02/2026] Trial Registered Prospectively |
| Last Modified On: |
19/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Single-arm, prospective, observational study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the predictive value of neuromuscular monitor-based quantitative sensory testing for postoperative pain and opioid requirement |
|
Scientific Title of Study
|
To study the predictive value of neuromuscular monitor-based quantitative sensory testing for postoperative pain and opioid requirement |
| 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 Shikha Gupta |
| Designation |
Professor Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia Dayanand Medical College and Hospital,Civil Lines,Ludhiana
Punjab
Ludhiana
PUNJAB
141001
India |
| Phone |
9814820622 |
| Fax |
|
| Email |
shikhadmc@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandandeep Kaur |
| Designation |
Junior resident Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia Dayanand Medical College and Hospital,Civil Lines,Ludhiana
Punjab
Ludhiana
PUNJAB
141001
India |
| Phone |
7986060876 |
| Fax |
|
| Email |
chandandeepkaur23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandandeep Kaur |
| Designation |
Junior resident Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia Dayanand Medical College and Hospital,Civil Lines,Ludhiana
Punjab
Ludhiana
PUNJAB
141001
India |
| Phone |
7986060876 |
| Fax |
|
| Email |
chandandeepkaur23@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Dayanand Medical College and Hospital |
| Address |
Tagore Nagar,Civil Lines,Ludhiana 141001,Punjab,India |
| 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 Shikha Gupta |
Dayanand Medical College and Hospital |
Department of Anaesthesia
Dayanand Medical College and Hospital, Civil lines Ludhiana
141001 Punjab India
Ludhiana
PUNJAB |
9814820622
shikhadmc@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical Committee,Dayanand Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K806||Calculus of gallbladder and bile duct with cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing laparoscopic cholecystectomy under general anaesthesia
Adults of either gender,ASA 1 and 2 |
|
| ExclusionCriteria |
| Details |
Pre-existing Chronic pain or Opioid abuse/previous surgical history
Neurological disorders
Psychiatric illness affecting pain reporting
Patients on medications affecting pain perception (e.g., antidepressants, antiepileptics).
Any medical condition that prevented the use of paracetamol or fentanyl in the post-operarative period
Patient refusal for the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the correlation between preoperative neuromuscular monitor–based QST pain thresholds and total postoperative opioid consumption (within first 24 hours).
To evaluate the correlation between preoperative pain threshold (mA) from neuromuscular monitor–based QST and postoperative pain severity in the first 24 hours.
To assess the feasibility, reproducibility, and safety of neuromuscular monitor–based QST in routine perioperative settings |
Postoperative pain severity and opioid consumption will be observed within first 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="53"
Sample Size from India="53"
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)
|
03/03/2026 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Effective post-operarative pain management remains a significant challenge in perioperative care of the patient. Treatment of post-operarative pain is an increasingly monitored measure for the quality of care offered to patients. Individual variability leads to varied pain experiences and affects responses to pain management among patients. Also, due to individual variability in pain sensitivity, standardized treatment protocols may not work equally well for all the patients. Although advances in analgesic techniques & multimodal pain management have improved postoperative pain control, there is still a considerable subset of patients who experience disproportionately severe pain leading to increased opioid requirement, prolonged hospital stay, delayed recovery and a higher risk of chronic post surgical pain. Anticipating such patients, who are likely to experience severe post -operative pain, could help clinicians tailor pain management strategies to improve outcomes. Several traditional Quantitative Sensory Testing(QST) methods which includes pressure algometry, thermal testing and electrical stimulation, have shown efficacy in predicting post-operarative pain responses by assessing patients’ reaction to various sensory stimuli. If a reliable correlation is established between preoperative stimulation response and postoperative pain intensity/opioid consumption, this method could offer a pragmatic and scalable solution for perioperative pain assessment, ultimately allowing clinicians to stratify patients based on their pain sensitivity and plan perioperative analgesia accordingly, enhancing both pain control and overall recovery. |