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

Primary Purpose

Injection Site Haematoma, Local Anesthetic Toxicity

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ultrasound guided serratus anterior plane block
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Injection Site Haematoma focused on measuring "SAPB", "MRM", "pain management"

Eligibility Criteria

20 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Ain Shams University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group A ( SAPB) group

Group B: control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
incidence of nausea and vomiting
patients are assessed for incidence of postoperative nausea and vomiting.
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.

Full Information

First Posted
October 26, 2021
Last Updated
November 16, 2021
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05126394
Brief Title
U/S Guided SAPB Versus Conventional IV Analgesics in Postoperative Pain Management in MRM
Acronym
SAPB
Official Title
A Comparative Study Between Ultrasound-guided Serratus Anterior Plane Block and Conventional IV Analgesics in Postoperative Pain Management in Modified Radical Mastectomy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 10, 2020 (Actual)
Primary Completion Date
October 10, 2021 (Actual)
Study Completion Date
October 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injection Site Haematoma, Local Anesthetic Toxicity
Keywords
"SAPB", "MRM", "pain management"

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective, randomized, controlled clinical trial.
Masking
ParticipantInvestigator
Masking Description
double blind
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A ( SAPB) group
Arm Type
Experimental
Arm Description
this group of patients receives serratus anterior plane block, just after induction of anesthesia.
Arm Title
Group B: control group
Arm Type
No Intervention
Arm Description
this group of patients does not receive any blockade, they receive conventional IV analgesics.
Intervention Type
Procedure
Intervention Name(s)
ultrasound guided serratus anterior plane block
Intervention Description
the patients receive local anesthetic (20 ml of Bupivacaine 0.25 %), injected superficial to the serratus muscle under ultrasound guidance.
Primary Outcome Measure Information:
Title
the time of first rescue analgesic
Description
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).
Time Frame
it is measured for 24 hours after the end of surgery.
Title
total dose of rescue analgesics
Description
the total dose of Pethidine needed by each patient measured in mg.
Time Frame
it is measured for 24 hours after the end of surgery.
Secondary Outcome Measure Information:
Title
patients satisfaction
Description
patients satisfaction is measured on a scale from 0 to 10, where 0 means not satisfied at all and 10 means the ultimate satisfaction.
Time Frame
24 hours after the end of surgery.
Title
incidence of nausea and vomiting
Description
patients are assessed for incidence of postoperative nausea and vomiting.
Time Frame
24 hours after the end of surgery.
Title
incidence of any block related complications.
Description
incidence of any serratus anterior plane block complications (e.g. injection site hematoma, signs and/or symptoms of local anesthetic toxicity ) is detected.
Time Frame
24 hours after the end of surgery.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hala Gomaa Salama, Medical Doctorate
Organizational Affiliation
Anesthesia department, Ain Shams University, Cairo, Egypt.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hanan Mahmoud Farag, Medical Doctorate
Organizational Affiliation
Anesthesia department, Ain Shams University, Cairo, Egypt.
Official's Role
Study Director
Facility Information:
Facility Name
Ain Shams University Hospitals
City
Cairo
State/Province
Abbasia
Country
Egypt

12. IPD Sharing Statement

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

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