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CTRI Number  CTRI/2025/03/082270 [Registered on: 13/03/2025] Trial Registered Prospectively
Last Modified On: 10/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Predicting long-term pain after keyhole gall bladder surgery before it occurs 
Scientific Title of Study   Prediction of chronic post-surgical pain in patients undergoing Laparoscopic Cholecystectomy before the transition time frame: A prospective 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  Sonam khokher 
Designation  Post resident  
Affiliation  Hamdard Institute of Medical Sciences and Research  
Address  Room number 701,7th Floor, Department of Anaesthesia,B- Block, Hamdard Institute of Medical Sciences and Research Jamia Hamdard, New Delhi-110062
Hamdard Institute of Medical Sciences and Research Jamia Hamdard, New Delhi-110062
New Delhi
DELHI
110062
India 
Phone  8010555917  
Fax    
Email  Sonamkhokher1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Pratibha Panjiar 
Designation  Professor 
Affiliation  Hamdard Institute of Medical Sciences and Research  
Address  Room number 701,7th Floor, Department of Anaesthesia,B- Block, Hamdard Institute of Medical Sciences and Research Jamia Hamdard, New Delhi-110062
Hamdard Institute of Medical Sciences and Research Jamia Hamdard, New Delhi-110062
New Delhi
DELHI
110062
India 
Phone  9311657822  
Fax    
Email  pratibha.panjiar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sonam khokher 
Designation  Post resident  
Affiliation  Hamdard Institute of Medical Sciences and Research  
Address  Room number 701,7th Floor, Department of Anaesthesia,B- Block, Hamdard Institute of Medical Sciences and Research Jamia Hamdard, New Delhi-110062
Hamdard Institute of Medical Sciences and Research Jamia Hamdard, New Delhi-110062
New Delhi
DELHI
110062
India 
Phone  8010555917  
Fax    
Email  Sonamkhokher1@gmail.com  
 
Source of Monetary or Material Support  
Hamdard institute of medical science and research and HAHC hospital,Guru Ravidas Marg, Block D, Hamdard Nagar, New Delhi, India 110062. 
 
Primary Sponsor  
Name  Hamdard Institute of Medical Sciences and Research Jamia Hamdard, New Delhi-110062 
Address  Hamdard Institute of Medical Sciences and Research Jamia Hamdard, New Delhi-110062 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sonam Khokher   Hamdard institute of medical science and research and HAHC hospital.  Room number 701,7th Floor, Department of Anaesthesia,B- Block.
New Delhi
DELHI 
8010555917

Sonamkhokher1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-HIMSR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  All patients aged 18-65yrs, posted for elective laparoscopic cholecystectomy, with American society of Anesthesiologist (ASA) physical status I-II. 
 
ExclusionCriteria 
Details  1) Patients with known psychiatric illness or neurological diseases or cognitive impairment
2) Patients with surgical site infection at POD14 or afterwards
3) Patients with documented drug addictive disorders
4) Patients in whom laparoscopic surgery was converted to open or intrasurgical drain was put in situ
5) Duration of surgery more than 120 mins
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To correlate the presence of pruritus on post operative day 1 with persistent pain on Post operative day 90 in patients undergoing laparoscopic cholecystectomy  2 weeks & 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the Quality of life (QoL) of the patients who undergo laparoscopic cholecystectomies by using SF 12 questionnaire on Post Operative Day 90.

To determine the incidence of chronic post surgical pain in the patients undergoing laparoscopic cholecystectomies at our institute 
2 weeks & 12 weeks 
 
Target Sample Size   Total Sample Size="550"
Sample Size from India="550" 
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)   24/03/2025 
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="1"
Months="5"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included Sonamkhokher1@gmail.com).

  6. For how long will this data be available start date provided 06-02-2025 and end date provided 06-02-2050?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

PREDICTION OF CHRONIC POST-SURGICAL PAIN IN PATIENTS UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY BEFORE THE TRANSITION TIME FRAME: A PROSPECTIVE OBSERVATIONAL STUDY

Chronic Post-Surgical Pain (CPSP) is defined as chronic pain that develops or increases in intensity after a surgical procedure or a tissue injury and persists beyond the healing process that is for at least three months, after the surgery.1 Its localization is either at the surgical site or projected onto the innervation zone of the nerve supplying the surgical site, or related to the corresponding dermatome, after surgery, or injury to the deep somatic and visceral tissues.

 

Macrae and Davies were the first to propose that specific criteria should be satisfied in order for chronic pain to be defined as post-surgical.1 These were - the pain must develop after a surgical procedure and must be of at least two months duration with other causes of the pain being ruled out.  

 

The incidence of CPSP has been reported for various surgical procedures in different studies, and  ranges from as low as 5% to as high as 85%.2 It has now been included in the International Classification of Diseases (ICD-11) to contribute to its identification, diagnosis, and therapy. The inclusion of CPSP in the ICD-11 is a major step forward that will allow future studies to report the incidence of CPSP more accurately. Furthermore, this raises awareness of this condition as a disease rather than merely a symptom, and the need for specific treatment and management.1 Presently, chronic pain specifier is pain severity rather than pain intensity alone and it encompasses three components, a) pain intensity b) pain-related distress, and c) pain-related interference with daily activities.3 

 

The pathophysiology of chronification of pain includes central (spinal and supraspinal) and peripheral (at the site of injury) sensitization. The inflammatory and the immune response to the axonal and the tissue damage plays the forerunner. The release of neurotransmitters peripherally and centrally, microglial activation, ectopic neural activity, altered activity in the dorsal horn, changes in the supraspinal processing and endogenous, descending pain pathway modulation play vital role in chronification of pain.

Since CPSP develops due to central sensitization, it show characteristics of neuropathic pain. The patients often report atypical clinical symptoms like hyperalgesia (increased painful sensation caused by a noxious stimulus), allodynia (painful sensation caused by a usually non-painful stimulus), and dysaesthesia (unpleasant touch perception or tingling) indicating nerve damage and central sensitization very early after surgery. It is theorized that in CPSP, painful sensations change from acute post-operative pain to complex and mixed pain syndromes comprising of nociplastic, neuropathic or characteristics of both.4 CPSP is known to add to a significant disease burden and decrease the quality of life.3 With the increasing number of surgeries worldwide, the burden of CPSP continues to have a high impact on the health care sector.

 

Studies suggest that transition from acute to chronic pain by peripheral and central inflammatory and sensitization processes starts as early as 2 weeks of nociceptive input. It is known that early identification of the patients at risk of developing CPSP is an essential step in reducing the pain chronification, hence many attempts are being made to identify the risk factors for the same.

 

Various risk factors have been recognized for prediction of CPSP. Young age, female gender, type of surgery, preexisting pain, opioid use, duration of surgery being some of them. However, it is important is to understand the interaction of risk factors in a wide range of surgical interventions. Predictive models with greater reliability to predict individual outcomes in the early post-operative period can be useful for the same.

 

Van Driel et al, in (2022) developed and validated one such early predictive model for CPSP.5 The final predictive model consists of preoperative treatment with opioids, worst pain score (NRS) on post-operative day1(POD1), presence of pruritis within the painful area onPOD1, pain score (NRS) on POD14 and presence of painful cold sensations within the painful area on POD14.

 

The formal and definitive means of testing is Quantitative Sensory Testing (QST) , however it is time-consuming and not feasible to be used in routine clinical settings, so the bedside QST has been used as an alternative.

CPSP also has an impact on the Quality of life,(QOL) which has been described by numerous studies in an attempt to recognize the risk factors for the same.  SF6 is one such validated tool to assess the same.6

 

5-56% patients with laparoscopic cholecystectomy have a risk of developing CPSP. However, there is no clear relation to the modality of surgery whether open/lap or timing of surgery.7 The development of post-operative pain might be due to tissue or nerve injury or inflammatory changes. The pain due to laparoscopic cholecystectomy can be either incisional (port site), visceral or shoulder tip pain.

 

It is estimated that in India at a particular time approximately 6-8 % of the population has symptomatic cholelithiasis and need cholecystectomy. Hence, as it forms a large proportion of the surgical procedures, so there is an added need to understand not only its perioperative course but also the late sequalae, CPSP being one such element.


 
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