Comparison of Different Volumes Spread of Erector Spinae Block in Post Mastectomy Pain Syndrome Management
1 other identifier
interventional
50
1 country
1
Brief Summary
Cancer breast is one of the most common tumors among women and surgery is still the key for its management and cure. Post-mastectomy pain control is crucial as acute postoperative pain is a significant factor in the development of persistent chronic pain in the form of post-mastectomy pain syndrome. Post-mastectomy pain syndrome (PMPS) is a common complication after breast cancer surgery and is often challenging to manage. It is estimated that PMPS occurs in 20%-44% of patients after breast surgery. Adequate pain control for PMPS has become one of the most important goals and recently can achieve by multiple tools including multimodal analgesia and regional techniques. Erector spinae block (ESB) is one of the new described regional techniques. Although its mechanism is not clear, the published data agree that it is promising block for chronic and acute pain and its simplicity and safety compared with thoracic epidural or bilateral paravertebral blocks. ESB can be performed using a superficial approach between the large rhomboid muscle and the erector spinae muscle or the deep method beneath the erector spinae. The use of the ESPB for chronic pain has recently expanded for various neuropathic pain conditions. Also, it reported with several volumes range from 10 to 30 ml of total volume.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 breast-cancer
Started Dec 2021
Shorter than P25 for phase_2 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 12, 2021
CompletedFirst Submitted
Initial submission to the registry
December 13, 2021
CompletedFirst Posted
Study publicly available on registry
January 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedJanuary 14, 2022
December 1, 2021
6 months
December 13, 2021
December 30, 2021
Conditions
Outcome Measures
Primary Outcomes (4)
The level spread of each volume.
The level spread of each volume.
immediately after injection. C arm photo will be taken to know the level of distribution
Numerical analogue scale
from 0 (no pain) to 10 (sever pain)
after 4 weeks from procedure
Numerical analogue scale
from 0 (no pain) to 10 (sever pain)
after 8 weeks from procedure
Numerical analogue scale
from 0 (no pain) to 10 (sever pain)
after 12 weeks from procedure
Secondary Outcomes (1)
Patient satisfaction
after 4 weeks from the procedure
Study Arms (2)
Group 20 ml
ACTIVE COMPARATORreceive ESB with 1mL of methylprednisolone 40mg/mL with 10 mL of 0.5% bupivacaine and 2mL of nonionic contrast in 7 ml saline 0.9% (total 20 ml with bupivacaine 0.25%).
Group 30 ml
ACTIVE COMPARATORreceive ESB with 1mL of methylprednisolone 40mg/mL with 15 mL of 0.5% bupivacaine and 2mL of nonionic contrast in 12 ml saline 0.9% (total 30 ml with bupivacaine 0.25%).
Interventions
The patients will do the procedure under fluoroscopic guidance. The patients were placed in prone position. After the identification of the T4 transverse process, the targeted injection site was anesthetized with 3-4 ml of 2% lidocaine. A 25-gauge spinal needle was advanced until it contacted the transverse process at the T4 level. Next, a solution of 1mL of methylprednisolone 40mg/mL with 7 mL of 0.25% bupivacaine and 2mL of nonionic contrast in 10 ml saline 0.9% (group A) and in 20 ml saline 0.9% (group B) will injected. Then another photo will be taken with the fluoroscopy to determine the level of spread in each group. After finished, the patients will transfer to the post-operative care unit and will monitored for any complication for one hour.
Eligibility Criteria
You may qualify if:
- Patients more than 18 years old of both genders
- with post-mastectomy pain syndrome not responding to medical treatments,
- and numeric rating scale (NRS) ≥ 4 that ranged from 0 (no pain) to 10 (extreme pain).,
- American society of Anesthesiology Physical Status class I and II,
- and Body mass index ˂ 30 were included in this study
You may not qualify if:
- patient refusal,
- local or systemic sepsis,
- coagulopathy,
- unstable cardiovascular
- and respiratory diseases,
- previous neurological deficits,
- history of psychiatric disorders,
- history of drug abuse,
- distorted local anatomy,
- and those who were allergic to the used medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nevert adel
Al Mansurah, Egypt
Related Publications (1)
Abdelghaffar NA, Amer GF. Comparison of different volumes spread of erector spinae block in postmastectomy pain syndrome management: a prospective randomized comparative study. BMC Anesthesiol. 2023 Aug 22;23(1):282. doi: 10.1186/s12871-023-02239-1.
PMID: 37608269DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assist. prof. of anesthesia and pain management
Study Record Dates
First Submitted
December 13, 2021
First Posted
January 14, 2022
Study Start
December 12, 2021
Primary Completion
June 1, 2022
Study Completion
September 1, 2022
Last Updated
January 14, 2022
Record last verified: 2021-12