Serratus Plane BlockNCT03615430
Serratus Plane Block in Preventing Postoperative Pain of Mastectomy
A study testing serratus plane block with local anesthetic and serratus plane block with saline in people with Serratus Plane Block and Chronic Pain, run by Feng Xia at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Serratus Plane Block, Chronic Pain, Breast Cancer
- What is being tested?
- serratus plane block with local anesthetic and serratus plane block with saline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2018to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong
About this study
Official title: The Effect of Serratus Plane Block in Preventing Postoperative Pain and Chronic Pain After Breast Cancer Surgery
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.
- Conditions
- Serratus Plane Block, Chronic Pain, Breast Cancer
- Being tested
- serratus plane block with local anesthetic, serratus plane block with saline
- Medical subject headings
- Chronic Pain, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serratus plane block with local anestheticProcedure or surgery
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.
serratus plane block with salineProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | 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 Receives: Procedure: serratus plane block with saline |
| SPB group | Experimental | 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 Receives: Procedure: serratus plane block with local anesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months after surgery
Secondary outcomes (2)
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
Measured: 0-24 hours after operation
Morphine consumption
extra need of analgesic
Measured: 0-24 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start1 Aug 2018
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Serratus Plane BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Feng Xia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Feng Xia, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Xia Feng, MD., Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03615430
- Sponsor's protocol ID
- [2016]124
- Status last verified
- Apr 2020
- First submitted
- 23 Jul 2018
- Last updated
- 8 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29227351
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Serratus Plane Block in Preventing Postoperative Pain and Chronic Pain After Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT03615430
- Acronym / sponsor ID
- [2016]124
- Conditions
- Serratus Plane Block, Chronic Pain, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Feng XiaUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 3 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Procedure: serratus plane block with salinesaline 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 |
| SPB group | Experimental | Procedure: serratus plane block with local anestheticSerratus 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serratus plane block with local anestheticThe 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. | Procedure or surgery | SPB group |
| serratus plane block with salineThe 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. | Procedure or surgery | Control group |
Primary outcome
Numerical Rating Scale (NRS) of chronic pain
Time frame: 3 months 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 effect of SPB in preventing chronic pain
2 secondary outcomes
the change trend of Numerical Rating Scale (NRS) after surgery
Time frame: 0-24 hours after operation
Morphine consumption
Time frame: 0-24 hours after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
- Background: PubMed 29227351Kamiya 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xia Feng, MD. principal investigator
First Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing serratus plane block with local anesthetic and serratus plane block with saline in people with Serratus Plane Block and Chronic Pain, run by Feng Xia at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale (NRS) of chronic pain (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03615430, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2020.