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Clinical Trials/CTRI/2025/07/089936
CTRI/2025/07/089936Not yet recruitingNot Applicable

Comparative analysis of pain on Propofol injection with pretreatment using Cold saline Lignocaine Cold saline plus Lignocaine and Normal saline in patients undergoing general anaesthesia A Prospective Observational Study

Hrithika1 site in 1 country132 target enrollmentStarted: July 14, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
132
Locations
1
Primary Endpoint
Incidence and severity of pain on propofol injection in patients pretreated with cold saline, lignocaine, cold saline + lignocaine and normal saline using pain score

Study Overview

Brief Summary

In this study "**COMPARATIVE ANALYSIS OF PAIN ON PROPOFOL INJECTION WITH PRETREATMENT USING COLD SALINE, LIGNOCAINE, COLD SALINE PLUS LIGNOCAINE AND NORMAL SALINE IN PATIENTS UNDERGOING GENERAL ANAESTHESIA: A PROSPECTIVE OBSERVATIONAL STUDY”**This prospective observational study is designed to evaluate pain during propofol injection in patients pretreated with cold saline, lignocaine, cold saline plus lignocaine and normal saline, to compare the efficacy of pre-treatment methods: cold saline, lignocaine and their combination to normal saline in providing pain relief on propofol injection (POPI) during various surgeries under general anaesthesia (G.A)

Attending anaesthesiologist will provide pretreatment and principal investigator will only observe and document the pain score

 The anaesthesia protocol will adhere to standard practices and anaesthesia will be provided by experienced anaesthesiologist. Monitoring will encompass standard parameters. A standard 20-gauge peripheral intravenous (IV) cannula will be placed into largest visible vein, preferably on dorsum of hand as standard practice to administer propofol. This study will include 132 participants of American Society of Anaesthesiologist physical Status (ASA PS) 1 or 2, of all genders in age group of 19-65 years undergoing GA will be enrolled in the study. Attending Anaesthesiologist will provide pretreatment as per patient posted for surgery under general anaesthesia, the patients will be assigned to one of the four pretreatment groups: In Group C-33 patients will receive 10ml cold saline at .Group L -33 patients will receive 3ml of lignocaine. Group CL- 33 patients will receive Cold saline plus lignocaine. In Group N- 33 patients will receive 10 ml of normal saline at room temperature, following pretreatment, patients will be given 5ml of propofol over 5 second. Soon after propofol injection, Principal investigator will ask the patient for any pain and signs of pain observed will be graded on pain score from none to severe. Principal investigator  will  record Heart rate before and after the propofol injection. After the surgery, patients will be shifted to the post-anesthesia care unit (PACU). Post-operative recall of pain on propofol injection will be assessed in the PACU by the principal investigator, once fully conscious, the patient will grade pain using the Numerical Rating Scale (NRS)

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
19.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1.The patient who are undergoing general anaesthesia and eligible cases during the study period are covered 2.American Society of Anaesthesiologist physical status (ASA PS) I and II 3.BMI 18-24 Kg/m2.

Exclusion Criteria

  • 1.Allergy to study medication 2.Serious venous insufficiency 3.Pregnant/lactating women.

Outcomes

Primary Outcomes

Incidence and severity of pain on propofol injection in patients pretreated with cold saline, lignocaine, cold saline + lignocaine and normal saline using pain score

Time Frame: pain score is taken Immediately after giving 5ml of propofol injection (within 5 to 10 seconds)

Secondary Outcomes

  • Post operative recall of pain on propofol injection in patients pretreated with cold saline, lignocaine, cold saline + lignocaine and normal saline(post-operatively patient will grade pain using numerical rating scale when fully conscious within 1-2 hours)

Investigators

Sponsor
Hrithika
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Hrithika

Yenepoya School Of Allied Health Sciences

Study Sites (1)

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