Clinical trial NCT04050059: Comparison of Two Analgesic Pretreatment Techniques Before Spinal Needle Insertion for Pain Reduction and Maternal Satisfaction Level Assessment in Women Undergoing LSCS.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Spinal
Pain
Pregnancy
Cesarean Section
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2019-08-08
Enrollment: 62
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: Pain Score (Subjective)
timeFrame: After 10 minutes (right after spinal anesthesia procedure is complete)
measure: Pain Score (Objective)
timeFrame: During spinal anesthesia procedure
measure: Maternal Satisfaction
timeFrame: After 10 minutes (right after spinal anesthesia procedure is complete)
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University
state: Sindh
Study officials:
References:
citation: 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.
citation: 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.
citation: 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
citation: 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.