comparing the efficacy of 3 medicated plasters for reducing of pain during placement of a needle into the veins in patients undergoing surgery

Not yet recruiting

Conditions: Medical and Surgical,

Registration Number: CTRI/2021/04/032982

Lead Sponsor: M S Ramaiah Medical College

Brief Summary: Peripheral Venous Cannulation (PVC) is an everyday practice in hospitals during which many patients experience pain and discomfort. It is a mandatory step during anaesthesia and in many other critical situations like resuscitation.Inadequate pain relief is not only unpleasant but may cause anxiety about further treatment deterring patients from seeking medical care in future.Topical anaesthetics applied locally to the vein before cannulation are non-invasive, well tolerated by patients and have been proven to be safe and efficacious.

Lidocaine is a synthetic amino ethylamide. It stabilizes the neuronal membrane by inhibiting ionic influxes required for the initiation and propagation of nerve impulses. A 5% lidocaine transdermal patch is available for topical analgesia. It comes as a single layer matrix patch which diffuses across the upper layers of the skin via passive diffusion from an area of high concentration to low concentration to produce an analgesic effect.

Ketoprofen is a propionic acid derivative and a non-steroidal anti-inflammatory drug (NSAID). It inhibits the activity of Cyclo-oxygenase (COX) 1 and 2 resulting in inhibition of prostaglandin and thrombaxane synthesis thereby decreasing the inflammatory response to cannulation and hence pain.Ketoprofen Transdermal patch when applied on the intact skin produces sufficient analgesia and has an advantage of minimizing thrombophlebitis due to its anti-inflammatory action.

Eutectic mixture of local anaesthetic (EMLA) Cream, a liquid emulsion is a eutectic mixture of the two amide local anaesthetics, namely Lidocaine 2.5% and Prilocaine 2.5%. When applied to the intact skin under occlusive dressing, EMLA cream releases lidocaine and prilocaine into the epidermal and dermal layers of the skin and provides analgesia by the accumulation of these anaesthetics in the vicinity of dermal pain receptors and nerve endings.A potential disadvantage of these topical agents could be the occurrence of erythema, induration or blanching at the site of their application. In the present study we seek to compare the analgesic efficacy of transdermal lidocaine 5% patch with transdermal ketoprofen patch and EMLA cream during PVC, as these modalities are easy to administer, non-invasive and with minimal adverse effects and drug interactions.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 240

Inclusion Criteria

ASA-1 to ASA-3 patients undergoing elective surgeries planned under General Anaesthesia.

Exclusion Criteria

Patients refusal to participate in the study.
Patients with documented allergy to the study drugs.
Patients with allergy to egg white.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess severity of pain on venous Cannulation among the 3 groups(Group Lidocaine, Group Ketoprofen and Group EMLA)	BASELINE

Secondary Outcome Measures

Name	Time	Method
1.To assess the severity of pain on injection of 20mg of 1	1% Propofol.

Trial Locations

Locations (1): M S Ramaiah Medical College
🇮🇳
Bangalore, KARNATAKA, India
M S Ramaiah Medical College
🇮🇳Bangalore, KARNATAKA, India
Dr Rahul Ramesh Pola
Principal investigator
8495000133
rahulsaysthat@gmail.com