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

Study Overview
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Brief Summary
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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
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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

Official Title
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Comparison of Two Analgesic Pretreatment Techniques (2% Lidocaine Infiltration vs. EMLA Cream Application) Before Spinal Needle Insertion for Pain Reduction and Maternal Satisfaction Level Assessment in Women Undergoing LSCS. A Prospective Randomized Control Trial

Conditions
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Anesthesia, Spinal, Pain, Pregnancy, Cesarean Section

Intervention / Treatment
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* Drug: EMLA cream
* Drug: 2% lidocaine


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2% Lidocaine group<br>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. | Drug: 2% lidocaine<br>* 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 needle insertion<br>|
| Active Comparator: EMLA cream group<br>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 | Drug: EMLA cream<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

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