The effect of erector spinae plane block on chronic pain after total mastectomy and immediate reconstruction with breast implant

The effect of erector spinae plane block on chronic pain after total mastectomy and immediate reconstruction with breast implant: a double-blind, randomized, placebo-controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005878

Enrollment

140

Registered

2021-02-09

Start date

2021-04-20

Completion date

Unknown

Last updated

2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Procedure/Surgery : The experimental group receive ultrasound-guided erector spinae plane block with 20 ml of 0.5% ropivacaine on the ipsilateral side of the surgical site before induction of anesthes

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Adult female patients undergoing total mastectomy and immediate reconstruction with breast implant

Exclusion criteria

Exclusion criteria: A. ASA physical status classification 3-4 B. Patients allergic to local anesthetics C. Patients with chronic pain, patients taking analgesics, antidepressants, and anticonvulsants D. Patients with medical or mental illness that will affect the response to treatment E. Patients requiring mechanical ventilation for more than 2 hours after surgery F. Patients determined to be inappropriate for the clinical trial by the researcher

Design outcomes

Primary

Measure	Time frame
Incidence of resting pain at the surgical site assessed using an 11-pointed numerical rating scale (NRS) pain score > 3	—

Secondary

Measure	Time frame
Quality of recovery assessed using a Korean version of the Quality of Recovery-15 questionnaire (QoR-15K);Postoperative pain and dose of analgesics;numerical rating scale (NRS) pain score;Postoperative nausea and vomiting;Resting pain at the surgical site assessed using an 11-pointed numerical rating scale (NRS) pain score;Pain during exercise at the surgical site assessed using an 11-pointed numerical rating scale (NRS) pain score;Quality of life assessed using a Korean version of the Euro-QoL-5D (EQ-5D) questionnaire	—

Measure

Time frame

Quality of recovery assessed using a Korean version of the Quality of Recovery-15 questionnaire (QoR-15K);Postoperative pain and dose of analgesics;numerical rating scale (NRS) pain score;Postoperative nausea and vomiting;Resting pain at the surgical site assessed using an 11-pointed numerical rating scale (NRS) pain score;Pain during exercise at the surgical site assessed using an 11-pointed numerical rating scale (NRS) pain score;Quality of life assessed using a Korean version of the Euro-QoL-5D (EQ-5D) questionnaire

—

Countries

Korea, Republic of

Contacts

Public ContactJinyoung Bae

Seoul National University Hospital

baejy88@gmail.com+82-2-2072-2467

Outcome results