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Is ultrasound-guided serratus plane block effective for acute and chronic pain after modified radical mastectomy?

Ultrasound-guided serratus plane block for acute pain and chronic pain after modified radical mastectomy: a prospective randomized trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000794404
Enrollment
198
Registered
2016-06-17
Start date
2016-07-04
Completion date
2018-04-23
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Breast cancer has continued to be the most common cancer afflicting women, every year, thousands of patients undergo surgery in the region of the breast and axilla. These procedures cause significant acute pain and may progress to chronic pain states in 25–60% of cases .A novel ultrasound-guided anaesthetic technique that may achieve complete paraesthesia of the hemithorax.Patients were allocated to either the general anesthesia group (group control) or SPB (serratus plane block) + general anesthesia groups (group SPB) by using randomized central computer-generated sequence software (SAS 18.0). The allocation ratio was 1:1 for the two groups. Group assignment was concealed by opaque sticking envelops and was given to the researchers.We will evaluate the pain in resting state and movement state by visual analog scale (visual analogue score, VAS), and to study the effect of serratus plane block on the acute pain and chronic pain after modified radical mastectomy.We predict this technique can block primarily the thoracic intercostal nerves and to provide complete analgesia of the lateral part of the thorax. We believe that this may be a viable alternative to paravertebral blockade and thoracic epidural analgesia in this patient population,and may theoretically be associated with a more desirable side-effect profile.

Interventions

30 minutes prior to induction of intravenous anesthesia, patients were received an ultrasound-guided serratus plane block., SPB group was performed with 0.5% ropivacaine 20ml by a single consultant anaesthetist. Patient controlled intravenous analgesia (PCIA) was starting at emergence from anaesthesia : sufentanil 3ug/kg+ tropisetron hydrochloride 0.01mg/kg (diluted with normal saline 100ml) were taken as protocol. The loading dosage was 2ml which administered at emergence from anaesthesia. , ba

30 minutes prior to induction of intravenous anesthesia, patients were received an ultrasound-guided serratus plane block., SPB group was performed with 0.5% ropivacaine 20ml by a single consultant anaesthetist. Patient controlled intravenous analgesia (PCIA) was starting at emergence from anaesthesia : sufentanil 3ug/kg+ tropisetron hydrochloride 0.01mg/kg (diluted with normal saline 100ml) were taken as protocol. The loading dosage was 2ml which administered at emergence from anaesthesia. , background infusion was 1ml/h; bolus dose was 1ml with 15 min lock out). The duration of PCIA is the first 48 hours post surgery.

Sponsors

Fujian Provincal Health and Family Planning Commission
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

Patients (aged 18 to 60 years) with American Society of Anesthesiologists (ASA) Physical Status class I or II scheduled for first modified radical mastectomy were included in the study.

Exclusion criteria

1. chronic ethanol, long-term use of psychotropic drugs (e.g. sedative drugs and antidepressant; 2. contraindications for Paravertebral block including coagulopathy, infection at the puncture site, trauma or history of spine surgery; 3. unable to cooperate with this research due to cognitive impairment, psychopathy or not willing for the hospital follow-up; 4. administration of other test drugs or joining in other clinical study in 3 months before our study; 5. received radiotherapy or chemotherapy before surgery; 6. other conditions not allocated for this study out of the researchers consideration.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026