Anesthesia, Spinal, Pain, Pregnancy, Cesarean Section
Conditions
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
Interventions
DRUGEMLA cream
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
DRUG2% 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 needle insertion
Sponsors
Aga Khan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
Pakistan
Outcome results
None listed