Comparative Study Between the Efficacy of The Serratus Anterior Plane Block and Lumbar Intrathecal Fentanyl Injection for Postoperative Analgesia After Modified Radical Mastectomy

NCT05352282 | Completed

• 1 other identifier: Soh-Med-22_03_02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients Undergoing Modified Radical Mastectomy

Outcome Measures

Primary Outcomes (1)

• analgesic effect of serratus anterior plane block and lumbar intrathecal fentanyl injection after modified radical mastectomy

  compare the analgesic effect between serratus anterior plane block and lumbar intrathecal fentanyl injection by using visual analogue score (vas). -Postoperative pain will be assessed using visual analog score (VAS) \[0-10\]. 0 - 3 mild pain 4 - 6 moderate pain 7 - 10 severe pain 10 \<unbearable pain)

  1 year

Secondary Outcomes (2)

• Hemodynamics effects of serratus anterior plane block and lumbar intrathecal fentanyl injection in patient undergoing modified radical mastectomy

  1 year

• Intra venous analgesics consumption after serratus anterior plane block and lumbar intrathecal fentanyl injection in patient undergoing modified radical mastectomy

  one year

Study Arms (2)

Group A

ACTIVE COMPARATOR

Procedure: Serratus Anterior Plane Block

Group B

ACTIVE COMPARATOR

Procedure: Lumbar Intrathecal Fentanyl Injection

Interventions

Serratus Anterior Plane Block PROCEDURE

SAPB will be done preoperative before induction of anesthesia under songraphic guidance and aseptic conditions with the patient in the lateral position, with the side of the surgical side up and the upper limb hanging over the patient's head. The ribs will be then counted, and when the 5th rib is identified, the high-frequency probe will be put over it, in the mid-axillary line in a sagittal plane. The ribs, pleura, overlying serratus muscle and latissimus dorsi muscle will be identified, and the needle will be advanced cephalic in-plane until the tip reaches the plane between the serratus anterior and latissimus dorsi. Afterward, 2 mL dextrose 5% will be injected; then, 30 mL of bupivacaine 0.25% will be injected in the plane between the serratus anterior and latissimus dorsi.

Group A

Lumbar Intrathecal Fentanyl Injection PROCEDURE

Patients will receive 25 microgram intracthecal fentanyl immediately preoperative.

Group B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related Publications (4)

• Amaya F, Hosokawa T, Okamoto A, Matsuda M, Yamaguchi Y, Yamakita S, Taguchi T, Sawa T. Can acute pain treatment reduce postsurgical comorbidity after breast cancer surgery? A literature review. Biomed Res Int. 2015;2015:641508. doi: 10.1155/2015/641508. Epub 2015 Oct 1.

  PMID: 26495309 BACKGROUND

• Wang L, Guyatt GH, Kennedy SA, Romerosa B, Kwon HY, Kaushal A, Chang Y, Craigie S, de Almeida CPB, Couban RJ, Parascandalo SR, Izhar Z, Reid S, Khan JS, McGillion M, Busse JW. Predictors of persistent pain after breast cancer surgery: a systematic review and meta-analysis of observational studies. CMAJ. 2016 Oct 4;188(14):E352-E361. doi: 10.1503/cmaj.151276. Epub 2016 Jul 11.

  PMID: 27402075 BACKGROUND

• 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.

  PMID: 29720750 BACKGROUND

• 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.

  PMID: 28584344 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at anesthesia and ICU department

Study Record Dates

• First Submitted: April 17, 2022
• First Posted: April 28, 2022
• Study Start: April 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

EG (1)