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NCT Number: NCT05126394

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

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)

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Key information

Conditions

Injection Site Haematoma Agnosia Local Anesthetic Toxicity Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

20 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University Hospitals

Cairo, Abbasia, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

Ultrasound guided serratus anterior plane block

Procedure

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

Primary outcomes

  1. the time of first rescue analgesic

    Time frame: 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).

  2. total dose of rescue analgesics

    Time frame: it is measured for 24 hours after the end of surgery.

    the total dose of Pethidine needed by each patient measured in mg.

Secondary outcomes

  1. patients satisfaction

    Time frame: 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.

  2. incidence of nausea and vomiting

    Time frame: 24 hours after the end of surgery.

    patients are assessed for incidence of postoperative nausea and vomiting.

  3. incidence of any block related complications.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Acronym: SAPB

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 19, 2021
Registry last updated
Nov 19, 2021

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

View the official ClinicalTrials.gov record (opens in a new tab)

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.

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