Skip to main content
OpenTrials
Completed

NCT Number: NCT04050059

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anesthesia, Spinal Cesarean Section Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pregnancy Signs and Symptoms

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aga Khan University

Karachi, Sindh, 74800, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 8, 2019
Registry last updated
Apr 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.