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

NCT02483923 | Completed

• 1 other identifier: 4-2015-0363
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

serratus anterior block; ultrasound; breast cancer; postoperative pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Postoperative pain scale (Numeric rating scale 0-10) at PACU

  chang from 3,6,12,24 to 48hrs after operation end

• Total intraoperative remifentanil consumption(mcg)

  within 24 hrs after mastectomy

• Additional analgesics requirements (dose/number)

  within 24 hrs after mastectomy

• incidence and intensity of postoperative nausea and vomiting(NRS:0-10)

  within 24 hrs after mastectomy

• Total hospital staying time

  within 24 hrs after mastectomy

Study Arms (2)

Group S

EXPERIMENTAL

Drug: Ultrasound guided serratus anterior block with ropivacaine

Group C

PLACEBO COMPARATOR

Drug: intravenous PCA only

Interventions

Ultrasound guided serratus anterior block with ropivacaine DRUG

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.

Group S

intravenous PCA only DRUG

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.

Group C

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA 1\~3
• Age 20\~80
• Breast cancer patient twho are scheduled for elective mastectomy

You may not qualify if:

• Allergy to local anesthetics or contraindication to use of ropivacaine
• Pregnancy
• Severe cardiovascular disease
• Renal failure
• Liver failure
• Neurologic and psychologic disease
• Chronic treatment with analgesics
• Previous history of mastectomy or thoracic surgery.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2015
• First Posted: June 29, 2015
• Study Start: June 16, 2015
• Primary Completion: February 28, 2016
• Study Completion: February 28, 2016
• Last Updated: July 17, 2018

Record last verified: 2018-07

Locations

KR (1)