U/S Guided SAPB Versus Conventional IV Analgesics in Postoperative Pain Management in MRM (SAPB)

A Comparative Study Between Ultrasound-guided Serratus Anterior Plane Block and Conventional IV Analgesics in Postoperative Pain Management in Modified Radical Mastectomy

The aim of this study is to compare the effect of ultra-sound guided serratus anterior plane block versus conventional IV analgesics in postoperative pain management in modified radical mastectomy (MRM)

Study Overview

• Status: Completed
• Conditions: Local Anesthetic Toxicity; Injection Site Haematoma
• Intervention / Treatment: Procedure: ultrasound guided serratus anterior plane block

Detailed Description

All patients undergoing modified radical mastectomy were assigned to one of the following two groups:Group A: Serratus anterior plane block group (SAPB group): this group consists of 20 patients who received ultra sound guided serratus anterior plane block just after induction of anesthesia and Group B: IV analgesics group (control group): this group consists of 20 patients who did not receive any type of block.Further evaluations were carried out by a different investigator who was unaware of the patients' grouping. The degree of post-operative pain was assessed at: just upon arrival to the PACU, 2, 4, 8, 12 and 24 hours using the VAS score and the haemodynamic data and respiratory rate were measured during the first 24 hours after the end of the surgery. Postoperative analgesia regimen was standard in both groups; patients from each groups received 1 gm of Paracetamol Q 8 hours.

Patients reporting VAS ( visual analogue score) score greater than 40, mean arterial blood pressure, heart rate or respiratory rate >20% from the baseline, were given Pethidine (50 mg IV) as rescue analgesic. While, those reporting VAS score less than 40 with mean arterial blood pressure, heart rate or respiratory rate >20% from the baseline but still complaining; Ketoralac (30 mg IV) was given with a maximum dose of 120 mg/ day.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Abbasia
    • Cairo, Abbasia, Egypt
      • Ain Shams University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Females aged between 20-60 years old.
• Preoperative physical status: ASA (American Society of Anesthesiology) I & II.
• Body mass index (BMI) < 35 Kg/ m2.
• Candidate for unilateral modified radical mastectomy.
• Informed consent to participate in the study.

Exclusion Criteria:

• - Females aged < 20 years old or > 60 years old.
• Preoperative physical status: ASA III & IV.
• Morbid obese patients with BMI > 35 Kg/ m2.
• Refusal to participate in the study.
• Addiction to narcotics or psycho-active drugs.
• Psychological disorders.
• Contra-indications to regional anesthesia (coagulopathy, injection site infection or allergy to any of the study drugs)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A ( SAPB) group; this group of patients receives serratus anterior plane block, just after induction of anesthesia.	Procedure: ultrasound guided serratus anterior plane block; the patients receive local anesthetic (20 ml of Bupivacaine 0.25 %), injected superficial to the serratus muscle under ultrasound guidance.
No Intervention: Group B: control group; this group of patients does not receive any blockade, they receive conventional IV analgesics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the time of first rescue analgesic	the time taken by the patient to receive first dose of rescue analgesia, guided by the patients VAS score ( if the patients VAS score is 4 or more, the patient receives 50 mg of Pethidine).	it is measured for 24 hours after the end of surgery.
total dose of rescue analgesics	the total dose of Pethidine needed by each patient measured in mg.	it is measured for 24 hours after the end of surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patients satisfaction	patients satisfaction is measured on a scale from 0 to 10, where 0 means not satisfied at all and 10 means the ultimate satisfaction.	24 hours after the end of surgery.
incidence of nausea and vomiting	patients are assessed for incidence of postoperative nausea and vomiting.	24 hours after the end of surgery.
incidence of any block related complications.	incidence of any serratus anterior plane block complications (e.g. injection site hematoma, signs and/or symptoms of local anesthetic toxicity ) is detected.	24 hours after the end of surgery.

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Hala Gomaa Salama, Medical Doctorate, Anesthesia department, Ain Shams University, Cairo, Egypt.; Study Director: Hanan Mahmoud Farag, Medical Doctorate, Anesthesia department, Ain Shams University, Cairo, Egypt.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2020
• Primary Completion (Actual): October 10, 2021
• Study Completion (Actual): October 10, 2021

Study Registration Dates

• First Submitted: October 26, 2021
• First Submitted That Met QC Criteria: November 16, 2021
• First Posted (Actual): November 19, 2021

Study Record Updates

• Last Update Posted (Actual): November 19, 2021
• Last Update Submitted That Met QC Criteria: November 16, 2021
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: "SAPB"; "MRM"; "pain management"
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Hemorrhage; Pain, Postoperative; Hematoma
• Other Study ID Numbers: FMASU MD 209a / 2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No