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

Not Applicable

Completed

• Conditions: Injection Site Haematoma; Local Anesthetic Toxicity
• Interventions: Procedure: ultrasound guided serratus anterior plane block

• Registration Number: NCT05126394
• Lead Sponsor: Ain Shams University

Brief Summary

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)

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 Timeline

• Status Verified: 2020-03
• Study Start: 2020-03-10
• Primary Completion: 2021-10-10
• Study Completion: 2021-10-10
• Study First Submitted: 2021-10-26
• Study First Submitted QC: 2021-11-16
• Last Update Submitted: 2021-11-16
• Study First Posted: 2021-11-19
• Last Update Posted: 2021-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A ( SAPB) group	ultrasound guided serratus anterior plane block	this group of patients receives serratus anterior plane block, just after induction of anesthesia.

Primary Outcome Measures

Name	Time	Method
the time of first rescue analgesic	it is measured for 24 hours after the end of surgery.	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).
total dose of rescue analgesics	it is measured for 24 hours after the end of surgery.	the total dose of Pethidine needed by each patient measured in mg.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ain Shams University Hospitals; 🇪🇬 Cairo, Abbasia, Egypt