Clinical trial NCT05352282: Comparative Study Between the Efficacy of The Serratus Anterior Plane Block and Lumbar Intrathecal Fentanyl Injection for Postoperative Analgesia After Modified Radical Mastectomy
Official title: Comparative Study Between the Efficacy of The Serratus Anterior Plane Block and Lumbar Intrathecal Fentanyl Injection for Postoperative Analgesia After Modified Radical Mastectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients Undergoing Modified Radical Mastectomy
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Modiﬁed radical mastectomy (MRM) is one of the most common surgeries performed, and one that may be associated with signiﬁcant acute postoperative pain in breast surgery. Acute postoperative pain is an independent risk factor in the development of chronic post-mastectomy pain .

Various regional anesthetic procedures have been tried to provide better acute pain control and, consequently, less chronic pain. They can reduce perioperative opiates requirement and thereby decreasing their possible side effects. These regional procedures include local wound inﬁltration, lumbar intrathecal fentanyl injection, thoracic epidural, thoracic paravertebral block (PVB), and ultrasound (US)-guided interfascial plane blocks. Currently, Ultrasound (US)-guided interfascial plane blocks have been recommended as safe, easy, and reliable alternatives to the use of thoracic epidural and paravertebral blocks in providing analgesia for patients about to undergo breast surgery.

Serratus anterior plane block (SAPB) is one of the Ultrasound (US)-guided interfascial plane blocks, it blocks the intercostal nerves II-VI by injection above or below the serratus muscle in the mid-axillary line and spares the pectoral nerves.

We assumed that SAPB could safely provide a better analgesic proﬁle with an opioid-sparing effect than Intrathecal fentanyl. We will perform this study to evaluate this assumption.


Eligibility criteria: Inclusion Criteria:

* 50 patients with American Society of Anesthesiologists (ASA) grade I to II, 18 to 60 years of age scheduled for Modified Radical Mastectomy surgery

Exclusion Criteria:

* Patient refusal.
* Patient with significant neurological , psychiatric or neuromuscular disease
* Alcoholism .
* Drug abuse .
* Pregnancy or lactating women .
* Suspected Coagulopathy .
* Morbid obesity .
* Known allergy to study medications .
* Septicaemia and local infection at the block site.

Primary outcomes:
measure: analgesic effect of serratus anterior plane block and lumbar intrathecal fentanyl injection after modified radical mastectomy
timeFrame: 1 year
Secondary outcomes:
measure: Hemodynamics effects of serratus anterior plane block and lumbar intrathecal fentanyl injection in patient undergoing modified radical mastectomy
timeFrame: 1 year
measure: Intra venous analgesics consumption after serratus anterior plane block and lumbar intrathecal fentanyl injection in patient undergoing modified radical mastectomy
timeFrame: one year
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
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citation: Garg R, Bhan S, Vig S. Newer regional analgesia interventions (fascial plane blocks) for breast surgeries: Review of literature. Indian J Anaesth. 2018 Apr;62(4):254-262. doi: 10.4103/ija.IJA_46_18.
citation: Garg R. Regional anaesthesia in breast cancer: Benefits beyond pain. Indian J Anaesth. 2017 May;61(5):369-372. doi: 10.4103/ija.IJA_292_17. No abstract available.