Injection Rate and Erector Spinae Plane Block

Sponsor

Antalya Training and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04895072

Collaborator

(none)

Enrollment

Location

Arms

6.5

Actual Duration (Months)

9.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain Breast Surgery	Procedure: Standard group Procedure: Long group	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 17, 2021

Actual Primary Completion Date :

Nov 30, 2021

Actual Study Completion Date :

Nov 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard group standard injection rate will be applied	Procedure: Standard group Ultrasound-guided ESP block with 20 mL %0.375 bupivacaine will be administered at a standard injection rate.
Active Comparator: Long group long injection rate will be applied	Procedure: Long group Ultrasound-guided ESP block with 20 mL %0.375 bupivacaine will be administered at a long injection rate.

Arm

Intervention/Treatment

Active Comparator: Standard group

standard injection rate will be applied

Procedure: Standard group

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

Active Comparator: Long group

long injection rate will be applied

Procedure: Long group

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

Outcome Measures

Primary Outcome Measures

Block sensory level [12 hours]
Number (average) of dermatomes with sensory block with pinprick and cold methods after the ESP block

Secondary Outcome Measures

Postoperative tramadol consumption [24 hours]
Postoperative tramadol consumption will be recorded at 24 hours
Assesment of postoperative analgesia [24 hours]
Post operative pain scores will be assessed using a numerical rating scala (NRS) (from 0=no pain, to10= worst pain imaginable).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation	Antalya		Turkey	07100

Sponsors and Collaborators

Antalya Training and Research Hospital

Investigators

Principal Investigator: Arzu Karaveli, Antalya TRH

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Antalya Training and Research Hospital

ClinicalTrials.gov Identifier:

NCT04895072

Other Study ID Numbers:

First Posted:

May 20, 2021

Last Update Posted:

Jan 4, 2022

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Antalya Training and Research Hospital

Erector spinae plane (ESP) block

Postoperative Pain

Breast Surgery

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Jan 4, 2022