- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT05192278
Comparison of Different Volumes Spread of Erector Spinae Block in Post Mastectomy Pain Syndrome Management
Comparison of Different Volumes Spread of Erector Spinae Block in Post Mastectomy Pain Syndrome Management: A Randomized Controlled Trial
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This prospective randomized open comparative study will be conducted in pain clinic, Mansoura University Hospitals. The study will be approved by the Ethics Research Committee of the Faculty of Medicine, Mansoura University and will be carried out in compliance with the Helsinki Declaration. Informed written consent will be signed from every patient participating in this study after full description of all details of every aspect in this study.
Patients more than 18 years old of both genders with PMPS 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.
The exclusion criteria are 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 were excluded from the study.
All the patients will inform about the numerical rating score (NRS) from zero to 10 (where 0 no pain, 10 the worst pain) to describe their pain.
Random selection of patients:
The study participants were randomly grouped on a scale of 1:1, using a computer-generated list of random numbers. The distribution results were sealed in an opaque envelope and kept by the study administrator. On the day of block, the study manager handed the envelope to the anesthesiologist who will perform the block.
Grouping:
Group A: receive ESR 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 B: receive ESR 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%).
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Phase 2
Kontakte und Standorte
Studienkontakt
- Name: yahya m wahba, assist professor
- Telefonnummer: 01211313554
- E-Mail: yahyawahba@ymail.com
Studieren Sie die Kontaktsicherung
- Name: ghada F Amer
- Telefonnummer: 01008081333
- E-Mail: ghadafouad2018@gmail.com
Studienorte
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-
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Mansoura, Ägypten
- Rekrutierung
- Nevert adel
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Kontakt:
- Yahya M Wahba, MD
- Telefonnummer: +201211313554
- E-Mail: yahyawahba@ymail.com
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Kontakt:
- ghada F Amer, ass. prof.
- Telefonnummer: 01008081333
- E-Mail: ghadafouad2018@gmail.com
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Unterermittler:
- ghada F Amer, MD
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Aktiver Komparator: Group 20 ml
receive 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%).
|
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.
|
Aktiver Komparator: Group 30 ml
receive 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%).
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
The level spread of each volume.
Zeitfenster: immediately after injection. C arm photo will be taken to know the level of distribution
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The level spread of each volume.
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immediately after injection. C arm photo will be taken to know the level of distribution
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Numerical analogue scale
Zeitfenster: after 4 weeks from procedure
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from 0 (no pain) to 10 (sever pain)
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after 4 weeks from procedure
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Numerical analogue scale
Zeitfenster: after 8 weeks from procedure
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from 0 (no pain) to 10 (sever pain)
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after 8 weeks from procedure
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Numerical analogue scale
Zeitfenster: after 12 weeks from procedure
|
from 0 (no pain) to 10 (sever pain)
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after 12 weeks from procedure
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Patient satisfaction
Zeitfenster: after 4 weeks from the procedure
|
evaluated by using a linear scale in which 0 is very dissatisfied and 10 is very satisfied.
|
after 4 weeks from the procedure
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Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- R.21.11.1523
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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