Back to resultsSerratus Plane Block in Preventing Postoperative Pain of Mastectomy
Primary Purpose
Serratus Plane Block, Chronic Pain, Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
serratus plane block with local anesthetic
serratus plane block with saline
Sponsored by
About this trial
This is an interventional treatment trial for Serratus Plane Block
Eligibility Criteria
Inclusion Criteria:
- women undergoing radical mastectomy with either sentinel lymph node dissection or axillary lymph node dissection or no axillary lymph node dissection
- between the ages of 18 and 85 yr
- with an American Society of Anesthesiology (ASA) physical status I or II
- without any significant cardiopulmonary, renal and hepatic dysfunction
Exclusion Criteria:
- Patients with any previous cancer other than breast cancer
- occurrence of allergy to local anesthetics
- occurrence of opioid-tolerant subjects
- occurrence of consuming analgesics, sedatives, antidepressants or any history of substance abuse before surgery
Sites / Locations
- Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-Sen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control group
SPB group
Arm Description
saline control group, 15 mL of the saline was administered to superficial and deep surface of serratus anterior in Control group via ultrasound before the surgery
Serratus plane block group, 15ml of 0.25% ropivacaine, a widely used local anesthetic for peripheral nerve block, was administered to superficial and deep surface of serratus anterior in SPB group via ultrasound before the surgery
Outcomes
Primary Outcome Measures
Numerical Rating Scale (NRS) of chronic pain
Pain intensity of patients was evaluated by Numerical Rating Scale, rating from 0 (no pain) to 10 (extreme pain) in order to evaluate the effect of SPB in preventing chronic pain
Secondary Outcome Measures
the change trend of Numerical Rating Scale (NRS) after surgery
Pain intensity of patients was evaluated by Numerical Rating Scale, rating from 0 (no pain) to 10 (extreme pain) in order to evaluate the analgesic effect of SPB
Morphine consumption
extra need of analgesic
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03615430
Brief Title
Serratus Plane Block in Preventing Postoperative Pain of Mastectomy
Official Title
The Effect of Serratus Plane Block in Preventing Postoperative Pain and Chronic Pain After Breast Cancer Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Feng Xia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
A prospective, double-blinded randomized controlled, 1-year follow-up study was designed to compare the analgesic effect of serratus plane block (SPB) after breast cancer surgery. Women undergoing radical mastectomy were dIvided into Control group and SPB group. The postoperative acute pain was evaluated by numerical rating scale (NRS) and the effect of preventing chronic pain was assessed at 3, 6, 12 months after surgery by NRS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Serratus Plane Block, Chronic Pain, Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
saline control group, 15 mL of the saline was administered to superficial and deep surface of serratus anterior in Control group via ultrasound before the surgery
Arm Title
SPB group
Arm Type
Experimental
Arm Description
Serratus plane block group, 15ml of 0.25% ropivacaine, a widely used local anesthetic for peripheral nerve block, was administered to superficial and deep surface of serratus anterior in SPB group via ultrasound before the surgery
Intervention Type
Procedure
Intervention Name(s)
serratus plane block with local anesthetic
Intervention Description
The high-frequency linear array ultrasound transducer (UST) was placed parallel to the cephalocaudal axis of the body in T4 levels on the side of the mid-axillary line, identifying latissimus dorsi and serratus anterior, through the thoracic artery to help to find the serratus anterior and 15 ml 0.25% ropivacaine was administered.
Intervention Type
Procedure
Intervention Name(s)
serratus plane block with saline
Intervention Description
The high-frequency linear array ultrasound transducer (UST) was placed parallel to the cephalocaudal axis of the body in T4 levels on the side of the mid-axillary line, identifying latissimus dorsi and serratus anterior, through the thoracic artery to help to find the serratus anterior and 15 ml saline was administered.
Primary Outcome Measure Information:
Title
Numerical Rating Scale (NRS) of chronic pain
Description
Pain intensity of patients was evaluated by Numerical Rating Scale, rating from 0 (no pain) to 10 (extreme pain) in order to evaluate the effect of SPB in preventing chronic pain
Time Frame
3 months after surgery
Secondary Outcome Measure Information:
Title
the change trend of Numerical Rating Scale (NRS) after surgery
Description
Pain intensity of patients was evaluated by Numerical Rating Scale, rating from 0 (no pain) to 10 (extreme pain) in order to evaluate the analgesic effect of SPB
Time Frame
0-24 hours after operation
Title
Morphine consumption
Description
extra need of analgesic
Time Frame
0-24 hours after operation
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
subject undergoing radical mastectomy
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women undergoing radical mastectomy with either sentinel lymph node dissection or axillary lymph node dissection or no axillary lymph node dissection
between the ages of 18 and 85 yr
with an American Society of Anesthesiology (ASA) physical status I or II
without any significant cardiopulmonary, renal and hepatic dysfunction
Exclusion Criteria:
Patients with any previous cancer other than breast cancer
occurrence of allergy to local anesthetics
occurrence of opioid-tolerant subjects
occurrence of consuming analgesics, sedatives, antidepressants or any history of substance abuse before surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xia Feng, MD.
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29227351
Citation
Kamiya Y, Hasegawa M, Yoshida T, Takamatsu M, Koyama Y. Impact of pectoral nerve block on postoperative pain and quality of recovery in patients undergoing breast cancer surgery: A randomised controlled trial. Eur J Anaesthesiol. 2018 Mar;35(3):215-223. doi: 10.1097/EJA.0000000000000762.
Results Reference
background
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Serratus Plane Block in Preventing Postoperative Pain of Mastectomy
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