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Completed

NCT Number: NCT04895072

Injection Rate and Erector Spinae Plane Block

To evaluate the effect of injection rate on the block sensory level in the ESP block.

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Key information

Conditions

Postoperative Pain Bites and Stings Breast Surgery Chemically-Induced Disorders Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Poisoning Postoperative Complications Signs and Symptoms Wounds and Injuries

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation

Antalya, 07100, Turkey (Türkiye)

About this study

Many women experience severe acute postoperative pain after breast cancer surgery. Regional techniques are frequently used as a part of multimodal analgesia in breast surgery. Ultrasound-guided erector spinae plane (ESP) block is a preferred method to reduce the postoperative opioid requirement for postoperative pain management. In this study, we aimed to evaluate the effect of injection rate on the block sensory level in the ESP block.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • aged between eighteen and sixty-five
  • ASA I-III
  • undergo elective breast cancer surgery

Exclusion criteria

  • under 18 years of age or over 65 years of age
  • ASA IV and above
  • declined to give written informed consent
  • contraindications of peripheral blocks or local anesthetic infiltration
  • history of allergy against local anesthetics
  • chronic pain history
  • history of hepatic, neuromuscular, cardiac and/or renal failure
  • infection at the injection site

Treatment and study plan

Standard group

Procedure

Ultrasound-guided ESP block with 20 mL %0.375 bupivacaine will be administered at a standard injection rate.

Long group

Procedure

Ultrasound-guided ESP block with 20 mL %0.375 bupivacaine will be administered at a long injection rate.

Primary outcomes

  1. Block sensory level

    Time frame: 12 hours

    Number (average) of dermatomes with sensory block with pinprick and cold methods after the ESP block

Secondary outcomes

  1. Postoperative tramadol consumption

    Time frame: 24 hours

    Postoperative tramadol consumption will be recorded at 24 hours

  2. Assesment of postoperative analgesia

    Time frame: 24 hours

    Post operative pain scores will be assessed using a numerical rating scala (NRS) (from 0=no pain, to10= worst pain imaginable).

Sponsors and collaborators

Lead sponsor

Antalya Training and Research Hospital

Other Gov

Registry information

Official study title

Effect of Injection Rate on the Block Sensory Level in the Erector Spine Plane Block

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 20, 2021
Registry last updated
Jan 4, 2022

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.

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