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

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ClinicalTrials.gov Identifier: NCT05126394
Recruitment Status : Completed
First Posted : November 19, 2021
Last Update Posted : November 19, 2021
Sponsor:
Information provided by (Responsible Party):
Ain Shams University

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)

Condition or disease Intervention/treatment Phase
Injection Site Haematoma Local Anesthetic Toxicity Procedure: ultrasound guided serratus anterior plane block Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A prospective, randomized, controlled clinical trial.
Masking: Double (Participant, Investigator)
Masking Description: double blind
Primary Purpose: Other
Official Title: A Comparative Study Between Ultrasound-guided Serratus Anterior Plane Block and Conventional IV Analgesics in Postoperative Pain Management in Modified Radical Mastectomy
Actual Study Start Date : March 10, 2020
Actual Primary Completion Date : October 10, 2021
Actual Study Completion Date : October 10, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A ( SAPB) group
this group of patients receives serratus anterior plane block, just after induction of anesthesia.
Procedure: 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.

No Intervention: Group B: control group
this group of patients does not receive any blockade, they receive conventional IV analgesics.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05126394


Locations
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Egypt
Ain Shams University Hospitals
Cairo, Abbasia, Egypt
Sponsors and Collaborators
Ain Shams University
Investigators
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Study Director: 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.
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Responsible Party: Ain Shams University
ClinicalTrials.gov Identifier: NCT05126394    
Other Study ID Numbers: FMASU MD 209a / 2021
First Posted: November 19, 2021    Key Record Dates
Last Update Posted: November 19, 2021
Last Verified: March 2020

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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
Keywords provided by Ain Shams University:
"SAPB"
"MRM"
"pain management"
Additional relevant MeSH terms:
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Pain, Postoperative
Hematoma
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Hemorrhage