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

Study Overview
=================
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.

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

Conditions
-----------------
Injection Site Haematoma, Local Anesthetic Toxicity

Intervention / Treatment
-----------------
* Procedure: ultrasound guided serratus anterior plane block


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective, randomized, controlled clinical trial.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A ( SAPB) group<br>this group of patients receives serratus anterior plane block, just after induction of anesthesia. | Procedure: ultrasound guided serratus anterior plane block<br>* the patients receive local anesthetic (20 ml of Bupivacaine 0.25 %), injected superficial to the serratus muscle under ultrasound guidance.<br>|
| No Intervention: Group B: control group<br>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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SAPB, MRM, pain management