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

Aga Khan University

Status: Completed

Conditions: Cesarean Section; Anesthesia, Spinal; Pain; Pregnancy

Treatments: Drug: EMLA cream; Drug: 2% lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04050059

2019-1791-4956

Details and patient eligibility

About

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.

Full 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

Enrollment: 62 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

2% Lidocaine group

Active Comparator group

Description:

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.

Treatment:

Drug: 2% lidocaine

EMLA cream group

Active Comparator group

Description:

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

Treatment:

Drug: EMLA cream