A prospective observational study of pain assessment after operation for planned cancer surgery

Not yet recruiting

Conditions: Medical and Surgical, (2) ICD-10 Condition: D499||Neoplasm of unspecified behavior of unspecified site, (3) ICD-10 Condition: R52||Pain, unspecified,

Registration Number: CTRI/2023/09/057736

Lead Sponsor: Tata Memorial Hospital

Brief Summary: Pain after cancer surgeries procedures can be severe. Pain management is based on a subjective criterion, and works best when patient is able to understand and communicate his level of pain. The adequacy of analgesic administered is also decided according to improvement in the subjective parameters which may vary from person to person. These variations are difficult to standardise. Hence objective criteria to guide pain management may be of certain help as an adjunct to the subjective criterion. Perfusion index is a parameter obtained non-invasively by a pulse oximeter probe. (Probe attached to a finger that gives a reading of level of oxygen on monitor) Perfusion index may be used as a objective criteria for pain assessment.

If you agree to participate in the study, the following which will be monitored ( HR, blood pressure ,oxygen saturation and perfusion index) during your stay in the recovery room, post surgery, as per standard of care, will be recorded for study purpose. All the above parameters will be noted half hourly for 2 hours in recovery room. Pain scores (NRS) will be noted hourly. Whenever patient has moderate to severe pain rescue pain killer (injection tramadol) will be given. The parameters (HR, BP, Perfusion index, oxygen saturation, and temperature) will be noted prior to administration of pain killer and 30 minutes after the administration of pain killer. The change in perfusion index as well as its correlation with pain scores will be noted

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 84

Inclusion Criteria

1.Adults : Age 18â€“80 years 2.ASA 1 and 2 3.Patients posted for surface surgeries which include ,breast surgery ( without reconstruction) , orthopedic surgeries ,head and neck surgeries awake , non intubated patient.

Exclusion Criteria

1.Severe cardiac disease (ischemic/valvular/failure related) which limit the functional activities of the patient, (above NYHA class 1) 2.History of chronic kidney disease, or current deranged renal functions, 3.History of liver disease, or current deranged liver functions, 4.Patients on preoperative opioids, both strong and weak opioids like Tramadol, codeine.
5.Patients with a history of a neurological, psychiatric, disorder, who were taking psychotropic drugs 6.Patients with allergy to any drug used in the study.
7.Postoperative unstable hemodynamic status, or on ventilator support 8.Patient who have received intraoperativeregionalanalgesia (Epidural/regional blocks) 9.Patients on anti hypertensive(NTG ) / Dexmedetomidine infusion 10.Patients with blood loss more than 1 litre.
11.Postoperative temperature less than 35 degree Celsius or 95 F 12.Surgeries which lasted for more than 3 hours.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To establish correlation between NRS score and PI or delta PI in PACU patients undergoing surface surgeries at a tertiary cancer care hospital.	The PI will be recorded every 30 mins after admission to recovery room at the time of the first request for analgesia At the time of the first request for analgesia NRS for pain intensity will be recorded
To analyse the trend of perfusion index with pain score	The PI will be recorded every 30 mins after admission to recovery room at the time of the first request for analgesia At the time of the first request for analgesia NRS for pain intensity will be recorded

Secondary Outcome Measures

Name	Time	Method
- To analyse the trend of perfusion index with pain score	Thirty minutes after postoperative analgesia, second measurements of the above-mentioned parameters will be taken simultaneously. (NRS for pain intensity, PI, HR, MAP, peripheral oxygen saturation, & axillary temperature.)

Trial Locations

Locations (1): Tata memorial hospital
🇮🇳
Mumbai, MAHARASHTRA, India
Tata memorial hospital
🇮🇳Mumbai, MAHARASHTRA, India
Dr Aparna Chatterjee
Principal investigator
9322243936
aparnasanjay@hotmail.com