Completed

NCT Number: NCT05352282

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

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.

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Key information

Conditions

Patients Undergoing Modified Radical Mastectomy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sohag University Hospital

Sohag, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Lumbar Intrathecal Fentanyl Injection

Procedure

Patients will receive 25 microgram intracthecal fentanyl immediately preoperative.

Primary outcomes

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

Time frame: 1 year

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)

Secondary outcomes

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

Time frame: 1 year

compare between serratus anterior plane block and lumbar intrathecal fentanyl injection as regard, hemodynamics of patient undergoing modified radical mastectomy.

-The heart rate (HR), noninvasive arterial systolic blood pressure (SBP), diastolic blood pressure (DBP) and peripheral oxygen saturation (SpO2) will be recorded at baseline, after induction and with skin incision and every 5 minutes intraoperative till the end of surgery. And postoperative at 30 min, 1, 2, 3, 6, 12 and 24 hours.
Intra venous analgesics consumption after serratus anterior plane block and lumbar intrathecal fentanyl injection in patient undergoing modified radical mastectomy

Time frame: one year

compare between serratus anterior plane block and lumbar intrathecal fentanyl injection in patient undergoing modified radical mastectomy as regard intra venous analgesics consumption.

All patients will receive paracetamol (15mg/KG/dose) immediately postoperative and after 6 hours. Patients will be assessed every one hour in the first 6 hours then every 3 hours in the next 18 hours.

Patients will receive ketorolac 30 mg if VAS 3-5 . If VAS>5 ,morphine 0.1mg/kg will be given then total ketorolac and morphine consumption in 24 hours will be calculated and compared between both groups .

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Apr 28, 2022
Registry last updated: Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.