Comparison of Two Analgesic Pretreatment Techniques Before Spinal Needle Insertion for Pain Reduction and Maternal Satisfaction Level Assessment in Women Undergoing LSCS.

Not Applicable

Completed

• Conditions: Pain; Pregnancy; Cesarean Section; Anesthesia, Spinal
• Interventions: Drug: EMLA cream; Drug: 2% lidocaine

• Registration Number: NCT04050059
• Lead Sponsor: Aga Khan University

Brief Summary

Nowadays lower segment cesarean sections are preferably carried out under regional anesthesia due to multiple advantages.

Local infiltration of lidocaine or any other anesthetic is used before lumber puncture in many centers to reduce needle stick pain.

EMLA (eutectic mixture of local anesthetic) cream is the combination of lidocaine and prilocaine which have been effectively used in few studies to reduce needle prick pain.

We would like to see which analgesic pretreatment is superior in terms of reducing pain of spinal needle insertion and have better maternal satisfaction levels.

Detailed Description

OBJECTIVES: To compare the pain reduction and maternal satisfaction levels of two analgesic pretreatment modalities on pain reduction of spinal needle insertion i.e. 2% lidocaine infiltration and EMLA in patients undergoing elective LSCS.

Hypothesis: Analgesic pre-treatment with EMLA is superior to local skin infiltration with lidocaine

Study Timeline

• Study First Submitted: 2019-08-04
• Study First Submitted QC: 2019-08-07
• Study First Posted: 2019-08-08
• Study Start: 2019-11-13
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-15
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-07
• Last Update Posted: 2020-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 62

Inclusion Criteria

• All adult women undergoing elective LSCS under spinal anesthesia

Exclusion Criteria

• BMI of more than 35 kg/m2
• Contraindication to spinal anesthesia
• Spinal deformity
• Refusal of regional anesthesia
• Patients with a history of back surgery
• confirmed allergy to local anesthetics
• More than three attempts of needle insertion for inducing spinal anesthesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EMLA cream group	EMLA cream	In EMLA (Eutectic Mixture of Local Anesthesia- lidocaine 2.5% and prilocaine 2.5%) cream group, EMLA cream (5g tube Aspen pharma trading limited) will be applied topically in dose of 2.5 grams (half tube of cream) and area will be covered with tegaderm dressing. Application of EMLA will at least stay for 30 minutes before spinal needle insertion
2% Lidocaine group	2% lidocaine	In 2% lidocaine group infiltration (Xylocaine 2% Barrett Hodgson Pakistan Pvt limited) skin and subcutaneous tissue will be infiltrated with 3 ml of 2% lidocaine (dose of 60 mg) before spinal anesthesia induction.

Primary Outcome Measures

Name	Time	Method
Maternal Satisfaction	After 10 minutes (right after spinal anesthesia procedure is complete)	Maternal Satisfaction Score (end of spinal anesthesia): Very Satisfied Satisfied No comments Unsatisfied Very Unsatisfied
Pain Score (Subjective)	After 10 minutes (right after spinal anesthesia procedure is complete)	Visual Analogue Scale pain Score in cm
Pain Score (Objective)	During spinal anesthesia procedure	Objective scoring: 1= No pain 2 = Mild flinch 3 = Wince 4= Yelp 5= Pulled away

Trial Locations

Locations (1)

Aga Khan University; 🇵🇰 Karachi, Sindh, Pakistan