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
|Condition or disease||Intervention/treatment||Phase|
|Injection Site Haematoma Local Anesthetic Toxicity||Procedure: ultrasound guided serratus anterior plane block||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A prospective, randomized, controlled clinical trial.|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||double blind|
|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|
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.
- 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.
- 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.
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
|Ain Shams University Hospitals|
|Cairo, Abbasia, Egypt|
|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.|