PATIENT SATISFACTION SURVEY - PAIN MANAGEMENT

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/05/004620
• Date of registration: 22-05-2014
• Prospective Registration: No
• Primary sponsor: Dr Balavenkat Subremanian
• Public title: PATIENT SATISFACTION SURVEY - PAIN MANAGEMENT
• Scientific title: PATIENT SATISFACTION SURVEY - PAIN MANAGEMENT - ASSIST
• Date of first enrolment: 12-05-2014
• Target sample size: 1200
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=9180
• Study type: Observational
• Study design: Other; Method of generating randomization sequence: Method of allocation concealment: Blinding and masking:
• Phase: N/A

Countries of recruitment

Bangladesh, India, Sri Lanka

Contacts

• Name: Dr Balavenkat Subramanian
• Affiliation: Ganga Medical Centre and Hospitals Pvt. Ltd

• Name: Dr Balavenkat Subramanian
• Affiliation: Ganga Medical Centre and Hospitals Pvt. Ltd

Key inclusion & exclusion criteria

Inclusion criteria: 1. Male or female patients aged over 18 years

2. Patients who have undergone any of the following elective surgeries

Orthopedics: Joint replacements, spine surgeries (open back surgeries)

Cardiology: Coronary artery bypass graft (CABG)

Open abdominal surgery

3. Postoperative pain management requiring administration of analgesics either by

intravenous or epidural route.

4. Patients willing to provide an informed consent, to be signed either by themselves or by

their legal representative.
Exclusion criteria: 1. Patients <18 years of age

2. Patients with a history of allergy to analgesics

3. Refusal to sign informed consent forms

4. Patients undergoing surgical procedures other than those specified in the inclusion

criteria to be excluded

4. Patients undergoing minimal invasive surgeries such as but not limited to laparoscopy,

arthroscopy, endoscopy, orthoscopy shall be excluded

5. Patients with ASA grade 4 to be excluded

6. Patients undergoing emergency surgeries to be excluded

7. Patients undergoing psychiatry treatment to be excluded

8. Patients receiving antiepileptic medication

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Patients who have undergone any of the following elective surgeries, such as Joint replacements, spine surgeries, Coronary artery bypass graft, Open abdominal surgery

Primary Outcome(s)

Mean postoperative pain and patient satisfaction scores comparison at rest and ambulation between the different modalities of pain managementTimepoint: 24 Hours, 48 hours and 72 hours

Secondary Outcome(s)

Difference in mean pain scores on pain scales and the patient satisfaction in the group receiving epidural route Vs. the IV routeTimepoint: 24 Hours, 48 hours and 72 hours

Caregiverâ??s perspective on difference in pain relief between the two groupsTimepoint: at 72 hours

Difference in amount of analgesic administered between the two groups (PCA Vs.non-PCA)Timepoint: 24 Hours, 48 hours and 72 hours

Difference in mean scores in patient satisfaction between the subgroups

ï?§ IV PCA vs. IV non-PCA

ï?§ Epidural PCA vs. Epidural non-PCATimepoint: 24 Hours, 48 hours and 72 hours

Secondary ID(s)

NIL

Source(s) of Monetary Support

Smiths Medical India Pvt Ltd

Ethics review

Status: Approved
Approval date: 15/01/2014
Contact:

Research and Ethical Practices Committee, Apollo Hospitals, Dhaka

Status: Approved
Approval date: 28/01/2014
Contact:

The Independent Ethics Committe, Fortis Escorts Heart Institute

Status: Approved
Approval date: 24/02/2014
Contact:

IEC, SGPGI, Lucknow

Status: Approved
Approval date: 19/03/2014
Contact:

Institutional Review Board, Ganga Medical Centre and Hospital Pvt Ltd, Coimbatore

Status: Approved
Approval date: 15/04/2014
Contact:

Ethics Committee, SAL Hospital and Medical Institute

Status: Approved
Approval date: 18/04/2014
Contact:

Medanta Institutional Ethics Committee

Status: Approved
Approval date: 29/04/2014
Contact:

Ethics Committee Sir Ganga Ram Hospital

Status: Not Approved
Approval date:
Contact:

ETHICS REVIEW COMMITTEE, NATIONAL HOSPITAL OF SRI LANKA, COLOMBO

Status: Not Approved
Approval date:
Contact:

Fernandez Hospital Ethics committee

Status: Not Approved
Approval date:
Contact:

Fortis Hospital Mulund Ethics Committee

Status: Not Approved
Approval date:
Contact:

Institute Ethics Committee, AIIMS

Status: Not Approved
Approval date:
Contact:

INSTITUTIONAL ETHICS COMMITTEE (IEC) NIZAMâ??S INSTITUTE OF MEDICAL SCIENCES

Status: Not Approved
Approval date:
Contact:

Institutional Ethics Committee (IEC), PGIMER, Chandigarh

Status: Not Approved
Approval date:
Contact:

Institutional Ethics Committee, PD Hinduja National Hospital and Medical Research Center