Analgesic Effect to Postoperative Pain After Mastectomy: Ultrasound-guided Serratus Anterior Plane Block

Breast Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02483923
• Other study ID #: 4-2015-0363
• Status: Completed
• Phase: N/A
• Start date: June 16, 2015
• Est. completion date: February 28, 2016

Study information

• Verified date: July 2018
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Ultrasound guided serratus anterior plane block may decrease acute postoperative pain and consumption of opioid after mastectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 28, 2016
• Est. primary completion date: February 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. ASA 1~3

2. Age 20~80

3. Breast cancer patient twho are scheduled for elective mastectomy

Exclusion Criteria:

1. Allergy to local anesthetics or contraindication to use of ropivacaine

2. Pregnancy

3. Severe cardiovascular disease

4. Renal failure

5. Liver failure

6. Neurologic and psychologic disease

7. Chronic treatment with analgesics

8. Previous history of mastectomy or thoracic surgery.

Related Conditions & MeSH terms

• Breast Cancer
• Pain, Postoperative

Intervention

Drug:
• Ultrasound guided serratus anterior block with ropivacaine
After induction of anesthesia, patients take ultrasound guided serratus anterior plane block with 0.5ml/kg of ropivacaine 0.375%. 30minutes before the end of operation, intravenous patient controlled analgesia (Basal rate 0ml/hr, 0.5mcg/kg of fentanyl, lock-out time 10minutes) is connected to patient.
• intravenous PCA only
same dose of intravenous patient controlled analgesia (Basal rate 0ml/hr, 0.5mcg/kg of fentanyl, lock-out time 10minutes) is connected to patient only.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total opioid consumption	Assessing total opioid consumption (total number of bolus injection and total dose of fentanyl via intravenous patient controlled analgesia) within 24hours after operation finished.	within 24 hrs after mastectomy
Secondary	Postoperative pain scale (Numeric rating scale 0-10) at PACU		chang from 3,6,12,24 to 48hrs after operation end
Secondary	Total intraoperative remifentanil consumption(mcg)		within 24 hrs after mastectomy
Secondary	Additional analgesics requirements (dose/number)		within 24 hrs after mastectomy
Secondary	incidence and intensity of postoperative nausea and vomiting(NRS:0-10)		within 24 hrs after mastectomy
Secondary	Total hospital staying time		within 24 hrs after mastectomy