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CTRI Number  CTRI/2025/08/092171 [Registered on: 01/08/2025] Trial Registered Prospectively
Last Modified On: 01/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Impact on acute pain services on post operative patients  
Scientific Title of Study   Impact of acute pain services on post operative patients in tertiary care hospital: 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  Mehak Bhasin 
Designation  Junior Resident 
Affiliation  King Georges Medical University Lucknow 
Address  Department of Anaesthesiology Gandhi memorial and Associated Hospital King George Medical University Shahmina road
Chowk Lucknow Uttar Pradesh
Lucknow
UTTAR PRADESH
226003
India 
Phone    
Fax    
Email  mehakbhasin99@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manish Kumar Singh 
Designation  Professor 
Affiliation  King Georges Medical University Lucknow 
Address  Department of Anaesthesiology Gandhi memorial and Associated Hospital King George Medical University Shahmina road
Chowk Lucknow Uttar Pradesh
Lucknow
UTTAR PRADESH
226003
India 
Phone  9453625852  
Fax    
Email  manish.is.singh34@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Manish Kumar Singh 
Designation  Professor 
Affiliation  King Georges Medical University Lucknow 
Address  Department of Anaesthesiology Gandhi memorial and Associated Hospital King George Medical University Shahmina road
Chowk Lucknow Uttar Pradesh

UTTAR PRADESH
226003
India 
Phone  9453625852  
Fax    
Email  manish.is.singh34@gmail.com  
 
Source of Monetary or Material Support  
Room No 1 Department of Anaesthesiology Gandhi Memorial and Associated Hospital King Georges Medical University Shahmina Road Chowk Lucknow 226003 Uttar Pradesh  
 
Primary Sponsor  
Name  Department of Anaesthesiology King Georges Medical CollegeLucknow 
Address  Department of Anaesthesiology Gandhi memorial and Associated Hospital King George Medical University Shahmina road Chowk Lucknow 226003 Uttar Pradesh  
Type of Sponsor  Government 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 Manish Kumar Singh  Department of Anaesthesiology  Department of Anaesthesiology Gandhi memorial and Associated Hospital King George Medical University Shahmina road Chowk Lucknow Uttar Pradesh
Lucknow
UTTAR PRADESH 
9453625852

manish.is.singh34@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G891||Acute pain, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Observational cohort. No comparator included in design of study.   Observational cohort. No comparator taken in design.  
Intervention  Pain assessment using vas  post surgical patients using VAS scale at 1,3 and 7 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients giving written informed consent
Adult patients (aged 18 years and above) undergoing elective major surgeries.
 
 
ExclusionCriteria 
Details  Patients not giving informed consent
Patients with pre-existing chronic pain conditions, those unable to consent, and individuals with significant cognitive impairments.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Pain scores will be recorded using the VAS scale at post op 1,3 and 7 days post-surgery  VAS scale at post op 1,3 and 7 days post-surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Analgesic consumption, patient-reported satisfaction, & adverse effects will be documented. Postoperative complications & recovery parameters, including time to mobilization & length of hospital stay, will be also collected  4 weeks 8 weeks & 12 weeks 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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)   15/08/2025 
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="1"
Months="0"
Days="1" 
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  

BACKGROUND AND RATIONALE 

 

Postoperative pain control is crucial for patients to return to normal function and minimize the negative effects of acute postsurgical pain. Traditionally, opioid analgesic therapy has been the primary treatment, but the rise in opioid misuse has necessitated more research into multimodal pain treatment strategies. In tertiary care hospitals, where surgery complexity and patient volume are high, the demand for efficient pain management strategies becomes even more pronounced. Acute Pain Services (APS) are a structured, multidisciplinary approach developed to address postoperative pain challenges. These services involve a team of healthcare professionals, including anesthesiologists, pain specialists, nurses, and physiotherapists, who collaborate to create and implement individualized pain management plans. The primary goal is to enhance pain control, reduce reliance on opioids, and minimize side effects associated with conventional pain relief methods. Multimodal analgesia has been shown to limit opioid consumption and provide more effective pain control than opioids alone. Hospitals are introducing APS to increase awareness of the importance of perioperative opioid-sparing analgesia and create surgery-specific analgesic protocols. APS employs multimodal analgesia, an evidence-based strategy that combines different classes of analgesic agents and techniques to provide synergistic pain relief. Techniques such as regional anesthesia, patient-controlled analgesia (PCA), and continuous peripheral nerve blocks are commonly used by APS to optimize pain management. Despite the proven benefits of APS, the implementation and impact vary widely among healthcare institutions. Factors such as resource availability, staff training, and institutional protocols influence the effectiveness of these services. Studies have shown that hospitals with well-established APS report better patient outcomes, including reduced postoperative pain scores, quicker mobilization, decreased length of hospital stay, and improved overall patient satisfaction. Sharma et al (2020) conducted a study on acute postoperative pain experiences, its interference with daily activities, emotions, sleep, and intra-operative pain response (IPR), and satisfaction with pain management among elective surgery patients. The results showed a high incidence of acute pain (82.5%), with significant interference with ADLs, sleep, and emotions. Most patients reported pain being assessed once or twice in each shift. Despite poor pain control, a majority of patients were satisfied with overall pain treatment (69%). Cruz et al (2021) conducted a prospective cross-sectional study on 2508 patients who underwent gynaecological and obstetrical surgery between January 2011 and February 2016. The study found that interventions with the highest reported pain scores were laparoscopic removal of ovarian cysts and caesarean section. Factors associated with higher pain intensity included younger age, chronic pain, and surgery performed outside the regular day shift. Shorter duration of surgery, peridural or local analgesic, and preoperative sedation reduced postoperative pain. Sundaram Venkatesan G et al (2022) conducted a prospective observational study in a tertiary care center in Coimbatore, India, to assess the efficacy of an ongoing pain management system. The results suggested the need for a policy change for quality improvement. Banerjee et al (2023) aimed to evaluate the intensity and severity of postoperative pain in patients undergoing orthopaedic, gastrointestinal, general surgery, obstetrics, and gynaecological surgeries in New Delhi, India. The study found that 48.7% of patients had moderate-to-severe pain on the first day after surgery, with pain severity being associated with poor recovery and patient satisfaction. Yoon et al (2024) developed a smartphone application for postoperative pain management and conducted a feasibility study. The SmartAPS application offered tools for postoperative pain assessment and educational materials for pain management. The TASMAN Collaborative (2024) study compared the outcomes for patients discharged with opioid versus opioid-free analgesia after common surgical procedures. After adjustment for confounders, opioid analgesia on discharge was independently associated with increased pain severity and re-presentation to healthcare providers owing to side-effects of medication. Opioid-free discharge analgesia should be adopted routinely to improve postoperative pain management in China.

Aims and Objectives

AIM:

·        To evaluate the impact of Acute Pain Services (APS) on postoperative outcomes (VAS scale at post op days 1,3 and 7) in patients at a tertiary care hospital

Objectives:

Primary Objective:

·        To assess the impact of APS on post op pain in post surgical patients using VAS scale at 1,3 and 7 days

Secondary Objectives:

·        To assess impact of APS on patient’s satisfaction on post op Day 1,3 and at the time of discharge using Likert scale

·        To assess impact of APS on evaluation recovery time

To assess impact of APS on post operative complications


 

MATERIAL AND METHODS

Study setting:

The study will be conducted in Department of Anaesthesiology, King George’s Medical University, Lucknow after written informed consent will be obtained from either of the patients/Guardian.  All patients undergoing major surgeries who consented to participate.

Study duration:

18 months

Study design:

Prospective Observational study

Sample size: For paired comparisons (e.g., VAS scores on postoperative days 1, 3, and 7 for the same patient), the following formula can be used:

n=43.56=44

The study uses a conservative sample size of 100 cases to ensure robustness, account for potential dropouts, and increase reliability, ensuring sufficient power and confidence in detecting meaningful changes in VAS scores postoperatively.

Inclusion Criteria:

·        Patients giving written informed consent

·        Adult patients (aged 18 years and above) undergoing elective major surgeries.

Exclusion Criteria:

·        Patients not giving informed consent

·        Patients with pre-existing chronic pain conditions, those unable to consent, and individuals with significant cognitive impairments.

Methodology:

Eligible patients will be enrolled preoperatively and followed postoperatively. The APS team provided a structured pain management protocol tailored to each patient, which included multimodal analgesia, regular pain assessments, and necessary adjustments to pain management plans.

Data Collection: Pain scores will be recorded using the VAS scale at post op 1,3 and 7 days post-surgery. Analgesic consumption, patient-reported satisfaction, and adverse effects will be  documented. Postoperative complications and recovery parameters, including time to mobilization and length of hospital stay, will be also collected.

 

Statistical analysis

The study used SPSS 26th for data analysis, analyzing categorical and continuous demographic variables. The study analyzed data using descriptive statistics, paired t-tests, and chi-square tests to compare pain scores and outcomes before and after APS intervention, with a p-value <0.05.

 


 

REFERENCES

1.      Bartels K, Mayes LM, Dingmann C, Bullard KJ, Hopfer CJ, Binswanger IA. Opioid Use and Storage Patterns by Patients after Hospital Discharge following Surgery. PLoS One. 2016;11(1):e0147972. [PMC free article] [PubMed]

2.      Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists’ Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. [PubMed]

3.      Suner ZC, Kalayci D, Sen O, Kaya M, Unver S, Oguz G. Postoperative analgesia after total abdominal hysterectomy: Is the transversus abdominis plane block effective? Niger J Clin Pract. 2019 Apr;22(4):478-484. [PubMed]

4.      Lovich-Sapola J, Smith CE, Brandt CP. Postoperative pain control. Surg Clin North Am. 2015 Apr;95(2):301-18. [PubMed]

5.      Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71.

6.      Glowacki D. Effective pain management and improvements in patients’ outcomes and satisfaction. Crit Care Nurse. 2015 Jun;35(3):33-41; quiz 43. doi: 10.4037/ccn2015440. PMID: 26033099.

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10. Ahmed A, Yasir M. Role of acute pain service in optimizing postoperative pain relief in a tertiary care teaching hospital. J Pak Med Assoc. 2015 Nov;65(11):1164-8. PMID: 26564285.

11. Sundaram Venkatesan G, Thulasiraman SV, Kesavan B, Chinnaraju N, Manoharan EV, Kesavan P. An Observational Study to Assess Postoperative Pain Control and Formulate a Comprehensive Approach to the Implementation of Policy Change for Pain Control in Postoperative Units. Cureus. 2022 Dec 27;14(12):e33026. doi: 10.7759/cureus.33026. PMID: 36589705; PMCID: PMC9797766.

12. Toro MM, John S, Faruqui AR.Pattern of use of analgesics in post-operative pain management in adults undergoing laparotomy surgery: a prospective observational study. Int Surg J2018;5:662-7.

13. Anwesha Banerjee, Ashok K Saxena, Neha Bhardwaj, Mohit K Srivastava. Postoperative Pain Management and Patient Satisfaction in an Indian Tertiary Care CentreA Prospective Observational Study. Journal of Clinical and Diagnostic Research. 2023 Apr, Vol-17(4): UC31-UC34

14. Jiménez Cruz, J., Kather, A., Nicolaus, K. et al. Acute postoperative pain in 23 procedures of gynaecological surgery analysed in a prospective open registry study on risk factors and consequences for the patient. Sci Rep 11, 22148 (2021). https://doi.org/10.1038/s41598-021-01597-5

15. Liu Y, Xiao S, Yang H, Lv X, Hou A, Ma Y, Jiang Y, Duan C, Mi W; CAPOPS Group. Postoperative pain-related outcomes and perioperative pain management in China: a population-based study. Lancet Reg Health West Pac. 2023 Jun 10;39:100822. doi: 10.1016/j.lanwpc.2023.100822. PMID: 37927993; PMCID: PMC10625022.

16. Yoon SH, Yoon S, Jeong DS, Lee M, Lee E, Cho YJ, Lee HJ. A smart device application for acute pain service in surgical patients at a tertiary hospital in South Korea: a prospective observational feasibility study. Anesth Pain Med (Seoul). 2024 Jul;19(3):216-226. doi: 10.17085/apm.24059. Epub 2024 Jul 23. PMID: 39069648; PMCID: PMC11317321.

17. TASMAN Collaborative , Impact of opioid-free analgesia on pain severity and patient satisfaction after discharge from surgery: multispecialty, prospective cohort study in 25 countries, British Journal of Surgery, Volume 111, Issue 1, January 2024, znad421

 

 

 
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