Comparison of analgesic efficacy of topical lignocaine-prilocaine cream with local infiltration of 2% lignocaine prior to spinal anaesthesia.

Completed

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2022/08/044614
• Lead Sponsor: Pandit BD Sharma PGIMS Rohtak

Brief Summary

Spinal anaesthesia is a simple, fast, safe and reliable method for surgery of the lower body that provides profound sensory and motor block by a single use of spinal needle to administer local anaesthetics into the subarachnoid space.1It is usually administered in the lumbar region in L3-L4 or L4-L5 space. The main reasons for rejecting neuraxial blocks are fear of needle, backache as well as anticipated immediate pain associated with lumbar puncture.2 Lumbar puncture requires more cooperation of the patients and may at times need multiple punctures which may cause pain and apprehensions in patients. Relieving the lumbar puncture pain not only increases the patient’s satisfaction and comfort, but also let the anaesthetist apply spinal puncture fast and easily.3

Lignocaine 2% solution is routinely used for infiltration of skin and subcutaneous tissues before lumbar puncture to reduce needle prick pain. Infiltration of local anaesthetics requires needle insertion which may itself cause acute pain and discomfort to the patient, may cause masking of anatomical landmarks which are used to identify the lumbar spaces and risks of accidental intravascular administrations.4 EMLA cream provides a non-invasive analgesia and has been effectively used in many studies to reduce needle prick pain.5,6

Eutectic mixture of local anaesthetics (EMLA) is an effective topical anaesthetic mixture containing lignocaine and prilocaine. The mixture is termed eutectic as it has a melting point lower than its individual components. The mixture is liquid at room temperature while the individual components are crystalline substances. EMLA is used for relieving the pain caused during venous and intra-arterial cannula insertions in paediatrics and adult patients, excision of cutaneous lesions, radiofrequency ablation of warts, fine-needle aspiration of thyroid nodules, minor surgical procedures such as during perineal repair after childbirth, for pain control during shockwave lithotripsy, humeral block placement in non-sedated patients, peribulbar injection, mammography, transrectal biopsy of prostate, hysterosalpingography, IUD insertions,  dental procedures, epidural injections and lumbar punctures.5,6

The purpose of this study is to find out the efficacy of topical EMLA cream in comparison to the standard infiltration technique in reducing pain of needle insertion during lumbar subarachnoid block and have better patient satisfaction level.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-15
• Study Completion: 2022-11-23
• Last Update Posted: 2024-01-28

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients of the age 18-60 years, of either sex belonging to ASA grade I and grade II undergoing 1.
• elective lower abdominal surgery 2.
• pelvic surgery 3.lower limb surgeries will be selected.

Exclusion Criteria

• Following patients will be excluded 1.Patients allergic EMLA cream or any other local anaesthetics.
• Pregnant and lactating females.
• Patients with methaemoglobinaemia 4.
• Psychiatric disorders 5.
• Fractures 6.
• More than 3 attempts at lumbar puncture.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•Primary objective - To compare the VAS score and 4-point pain score of topical EMLA cream with Lignocaine infiltration during subarachnoid block.	1.VAS Score will be assessed immediately (within 5 minutes) after lumbar subarachnoid block on the scale of 0-10. | 2.the 4-point pain scale will be assessed at the time of spinal needle insertion as: | 0 – no response | 1 - mild facial grimace | 2 - verbal response | 3 - movement of the back

Secondary Outcome Measures

Name	Time	Method
Secondary objective -	1. Haemodynamic response to pain,

Trial Locations

Locations (1)

Pandit BD Sharma Post Graduate Institute of Medical Sciences, Rohtak; 🇮🇳 Rohtak, HARYANA, India

Pandit BD Sharma Post Graduate Institute of Medical Sciences, Rohtak

🇮🇳Rohtak, HARYANA, India

Teyiesito Yano

Principal investigator

9774921342

teyie.yano@gmail.com