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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

Tracking Information
First Submitted Date  ICMJE October 26, 2021
First Posted Date  ICMJE November 19, 2021
Last Update Posted Date November 19, 2021
Actual Study Start Date  ICMJE March 10, 2020
Actual Primary Completion Date October 10, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2021)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2021)
  • 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.
  • incidence of nausea and vomiting [ Time Frame: 24 hours after the end of surgery. ]
    patients are assessed for incidence of postoperative nausea and vomiting.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE U/S Guided SAPB Versus Conventional IV Analgesics in Postoperative Pain Management in MRM
Official Title  ICMJE A Comparative Study Between Ultrasound-guided Serratus Anterior Plane Block and Conventional IV Analgesics in Postoperative Pain Management in Modified Radical Mastectomy
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Injection Site Haematoma
  • Local Anesthetic Toxicity
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Group A ( SAPB) group
    this group of patients receives serratus anterior plane block, just after induction of anesthesia.
    Intervention: Procedure: ultrasound guided serratus anterior plane block
  • No Intervention: Group B: control group
    this group of patients does not receive any blockade, they receive conventional IV analgesics.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 16, 2021)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 10, 2021
Actual Primary Completion Date October 10, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05126394
Other Study ID Numbers  ICMJE FMASU MD 209a / 2021
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Ain Shams University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Ain Shams University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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.
PRS Account Ain Shams University
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP