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

NCT04050059 | Completed DMC

• 1 other identifier: 2019-1791-4956
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia, Spinal; Pain; Pregnancy; Cesarean Section

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (2)

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.

Drug: 2% lidocaine

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

Drug: EMLA cream

Interventions

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

EMLA cream group

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

2% Lidocaine group

Eligibility Criteria

• Gender Eligibility Details: Female pregnant patient planned for elective cesarean section under spinal anesthesia
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult women undergoing elective LSCS under spinal anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

Location

Related Publications (4)

• 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.

  PMID: 10193230 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.

  PMID: 8956393 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

  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.

  PMID: 8913402 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Lidocaine, Prilocaine Drug Combination; Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow Obstetric Anesthesiology

Study Record Dates

• First Submitted: August 4, 2019
• First Posted: August 8, 2019
• Study Start: November 13, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 15, 2019
• Last Updated: April 8, 2020

Record last verified: 2020-04

Locations

PA (1)