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

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ClinicalTrials.gov Identifier: NCT04050059
Recruitment Status : Completed
First Posted : August 8, 2019
Last Update Posted : April 8, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Malika Hameed, Aga Khan University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Anesthesia, Spinal Pain Pregnancy Cesarean Section Drug: EMLA cream Drug: 2% lidocaine Not Applicable

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : November 13, 2019
Actual Primary Completion Date : December 1, 2019
Actual Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 2% Lidocaine group
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
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
Active Comparator: EMLA cream group
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
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


Outcome Measures
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Primary Outcome Measures :
  1. Pain Score (Subjective) [ Time Frame: After 10 minutes (right after spinal anesthesia procedure is complete) ]
    Visual Analogue Scale pain Score in cm

  2. Pain Score (Objective) [ Time Frame: During spinal anesthesia procedure ]

    Objective scoring:

    1= No pain 2 = Mild flinch 3 = Wince 4= Yelp 5= Pulled away


  3. Maternal Satisfaction [ Time Frame: 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



Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female pregnant patient planned for elective cesarean section under spinal anesthesia
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04050059


Locations
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Pakistan
Aga Khan University
Karachi, Sindh, Pakistan, 74800
Sponsors and Collaborators
Aga Khan University
More Information
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Publications:
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

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Responsible Party: Dr. Malika Hameed, Fellow Obstetric Anesthesiology, Aga Khan University
ClinicalTrials.gov Identifier: NCT04050059    
Other Study ID Numbers: 2019-1791-4956
First Posted: August 8, 2019    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lidocaine
Lidocaine, Prilocaine Drug Combination
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
 Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anesthetics, Combined