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

NCT ID: NCT05126394

Last Updated: 2021-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-10

Study Completion Date

2021-10-10

Brief Summary

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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

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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.

Conditions

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Injection Site Haematoma Local Anesthetic Toxicity

Keywords

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"SAPB" "MRM" "pain management"

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A prospective, randomized, controlled clinical trial.
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators
double blind

Study Groups

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Group A ( SAPB) group

this group of patients receives serratus anterior plane block, just after induction of anesthesia.

Group Type EXPERIMENTAL

ultrasound guided serratus anterior plane block

Intervention Type PROCEDURE

the patients receive local anesthetic (20 ml of Bupivacaine 0.25 %), injected superficial to the serratus muscle under ultrasound guidance.

Group B: control group

this group of patients does not receive any blockade, they receive conventional IV analgesics.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hala Gomaa Salama, Medical Doctorate

Role: STUDY_DIRECTOR

Anesthesia department, Ain Shams University, Cairo, Egypt.

Hanan Mahmoud Farag, Medical Doctorate

Role: STUDY_DIRECTOR

Anesthesia department, Ain Shams University, Cairo, Egypt.

Locations

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Ain Shams University Hospitals

Cairo, Abbasia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FMASU MD 209a / 2021

Identifier Type: -

Identifier Source: org_study_id