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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2% Lidocaine group | Active Comparator | 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. |
|
| EMLA cream group | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMLA cream | Drug | 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
Female pregnant patient planned for elective cesarean section under spinal anesthesia
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aga Khan University | Karachi | Sindh | 74800 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10193230 | Background | Koscielniak-Nielsen Z, Hesselbjerg L, Brushoj J, Jensen MB, Pedersen HS. EMLA patch for spinal puncture. A comparison of EMLA patch with lignocaine infiltration and placebo patch. Anaesthesia. 1998 Dec;53(12):1218-22. doi: 10.1046/j.1365-2044.1998.00608.x. | |
| 8956393 | Background | Sharma SK, Gajraj NM, Sidawi JE, Lowe K. EMLA cream effectively reduces the pain of spinal needle insertion. Reg Anesth. 1996 Nov-Dec;21(6):561-4. |
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| 2% lidocaine | Drug | 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 |
|
| Background | Wenk M, Massoth C, Weidlich S, Pöpping D M, Gurlit S, et al. Effects of local skin anaesthesia on pain during lumbar puncture. J Anaesthesiol Crit Care. 2017;1 (1):1-5 |
| 8913402 | Background | Juarez Gimenez JC, Oliveras M, Hidalgo E, Cabanas MJ, Barroso C, Moraga FA, Gallego S, de Toledo JS. Anesthetic efficacy of eutectic prilocaine-lidocaine cream in pediatric oncology patients undergoing lumbar puncture. Ann Pharmacother. 1996 Nov;30(11):1235-7. doi: 10.1177/106002809603001104. |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077442 | Lidocaine, Prilocaine Drug Combination |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D011318 | Prilocaine |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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