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

NCT05126394 | Completed

• 1 other identifier: FMASU MD 209a / 2021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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)

Conditions

Injection Site Haematoma; Local Anesthetic Toxicity

Keywords

"SAPB"; "MRM"; "pain management"

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• patients satisfaction

  24 hours after the end of surgery.

• incidence of nausea and vomiting

  24 hours after the end of surgery.

• incidence of any block related complications.

  24 hours after the end of surgery.

Study Arms (2)

Group A ( SAPB) group

EXPERIMENTAL

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

Procedure: ultrasound guided serratus anterior plane block

Group B: control group

NO INTERVENTION

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

Interventions

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.

Group A ( SAPB) group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \- 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)

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Abbasia, Egypt

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hala Gomaa Salama, Medical Doctorate

  Anesthesia department, Ain Shams University, Cairo, Egypt.

  STUDY DIRECTOR

• Hanan Mahmoud Farag, Medical Doctorate

  Anesthesia department, Ain Shams University, Cairo, Egypt.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blind
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective, randomized, controlled clinical trial.

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 19, 2021
• Study Start: March 10, 2020
• Primary Completion: October 10, 2021
• Study Completion: October 10, 2021
• Last Updated: November 19, 2021

Record last verified: 2020-03

Locations

EG (1)