Injection Rate and Erector Spinae Plane Block

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04895072
• Other study ID #: 4/5
• Status: Completed
• Phase: N/A
• Start date: May 17, 2021
• Est. completion date: November 30, 2021

Study information

• Verified date: May 2021
• Source: Antalya Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Surgery
• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Standard group
Ultrasound-guided ESP block with 20 mL %0.375 bupivacaine will be administered at a standard injection rate.
• Long group
Ultrasound-guided ESP block with 20 mL %0.375 bupivacaine will be administered at a long injection rate.

Locations

Country	Name	City	State
Turkey	Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Antalya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Barrios A, Camelo J, Gomez J, Forero M, Peng PWH, Visbal K, Cadavid A. Evaluation of Sensory Mapping of Erector Spinae Plane Block. Pain Physician. 2020 Jun;23(3):E289-E296. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Block sensory level	Number (average) of dermatomes with sensory block with pinprick and cold methods after the ESP block	12 hours
Secondary	Postoperative tramadol consumption	Postoperative tramadol consumption will be recorded at 24 hours	24 hours
Secondary	Assesment of postoperative analgesia	Post operative pain scores will be assessed using a numerical rating scala (NRS) (from 0=no pain, to10= worst pain imaginable).	24 hours