Skip to main content
Clinical Trials/NCT05126394
NCT05126394
Completed
Not Applicable

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

Ain Shams University1 site in 1 country40 target enrollmentMarch 10, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Injection Site Haematoma
Sponsor
Ain Shams University
Enrollment
40
Locations
1
Primary Endpoint
the time of first rescue analgesic
Status
Completed
Last Updated
4 years ago

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.

Registry
clinicaltrials.gov
Start Date
March 10, 2020
End Date
October 10, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

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/ m
  • 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/ m
  • 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)

Outcomes

Primary Outcomes

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).

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

  • incidence of nausea and vomiting(24 hours after the end of surgery.)
  • patients satisfaction(24 hours after the end of surgery.)
  • incidence of any block related complications.(24 hours after the end of surgery.)

Study Sites (1)

Loading locations...

Similar Trials