| CTRI Number |
CTRI/2025/07/092099 [Registered on: 31/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding how pulse monitor readings relate to pain after gallbladder surgery |
|
Scientific Title of Study
|
Correlation of the surgical pleth index with the postoperative pain in laparoscopic cholecystectomy an observational 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 |
Prajna Acharya |
| Designation |
Postgraduate student |
| Affiliation |
Manipal College Of Health Professions |
| Address |
Anaesthesia and operation theatre technology Programme 4th floor Manipal College of health professions Manipal Academy of Higher Education Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9606251417 |
| Fax |
|
| Email |
prajna.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meghna Rao |
| Designation |
Assistant Professor and Guide |
| Affiliation |
Kasturba Medical College and Hospital |
| Address |
Department of Anaesthesiology, Kasturba Medical College Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8123506425 |
| Fax |
|
| Email |
meghna.rao@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Prajna Acharya |
| Designation |
Postgraduate student |
| Affiliation |
Manipal College Of Health Professions |
| Address |
Anaesthesia and operation theatre technology Programme 4th floor Manipal College of health professions Manipal Academy of Higher Education Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9606251417 |
| Fax |
|
| Email |
prajna.mchpmpl2024@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India, PIN 576104 |
|
|
Primary Sponsor
|
| Name |
Prajna Acharya |
| Address |
Anaesthesia and Operation Theatre Technology Programme, 4th floor , Manipal College of Health Professions, Manipal Academy of Higher Education, Msnipal, Udupi district, Karnataka, India , PIN 576104 |
| 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 Meghna Rao |
Kasturba Hospital |
Operation Theatre Complex 1st floor Kasturba Hospital Manipal Karnataka India
Udupi
KARNATAKA |
8123506425
meghna.rao@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee- 2 (Student Research) |
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 |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Participants undergoing elective laparoscopic cholecystectomy under General Anaesthesia
ASA Physical Status 1 and 2
|
|
| ExclusionCriteria |
| Details |
Participants with hypertension and antihypertensive medications especially beta blockers
Participants with long standing Diabetes Mellitus
Chronic smokers
Participants with significant dysrhythmias
Participants who receive neuraxial blockade before the surgery
Participants with implanted pacemaker
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess correlation of intraoperative SPI values with Postoperative pain scores in patients undergoing elective Laparoscopic Cholecystectomy under General Anaesthesia |
Preoperative period, Intraoperative period and postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Investigate the influence of patient’s demographic factors such as Age, Duration of surgery, comorbidities & intraoperative analgesic intervention on predictive capability of SPI on postoperative pain |
On the day of surgery in Preoperative period, Intraoperative period & pain score in postoperative period once patients achieve RASS score of 0 or -1 at 5 minutes 15 minutes, 1 hour & 4 hours |
|
|
Target Sample Size
|
Total Sample Size="87"
Sample Size from India="87"
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)
|
11/08/2025 |
| 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="8"
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
|
This prospective cross-sectional observational study titled Correlation of the Surgical Pleth Index with Postoperative Pain in Laparoscopic Cholecystectomy aims to examine the relationship between intraoperative Surgical Pleth Index (SPI) values recorded at six specific timepoints during elective laparoscopic cholecystectomy under general anesthesia and postoperative pain intensity. The primary objective is to assess whether intraoperative SPI levels correlate with postoperative pain scores. Secondary objectives include evaluating how demographic factors (age), duration of surgery, comorbidities, and intraoperative analgesic use influence this correlation. There is a notable gap in the literature, as no prior studies have assessed SPI at multiple intraoperative intervals in this surgical context. The findings could inform perioperative pain assessment and individualized analgesic strategies in a routinely performed surgical procedure |