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Clinical trial

Effect of Adding Dexmedetomidine as Adjuvant to Bupivacaine in Ultrasound Guided Erector Spinae Plane Block for Post Modified Radical Mastectomy Pain Management

ID
Name
erector spinae plane block
Description
The aim of the study is to assess the effect of adding dexmedetomidine to bupivacaine in US guided erector spinae plane block in modified radical mastectomy surgeries , Using visual analogue score and post-operative narcotics consumption. Peripheral nerve blocks are effective adjuvant options for pain management in breast surgeries. The use of Erector spinae plane block (ESPB) has been proven to be very effective in controlling pain and minimizing narcotic consumption after modified radical mastectomy surgeries. Many adjuvants to local anaesthetics were used to improve the duration and intensity of the peripheral nerve block.
Trial arms
Trial start
2023-08-15
Estimated PCD
2024-06-01
Trial end
2024-07-01
Status
Recruiting
Treatment
Use Bupivacaine 0.25% Injectable Solution
Group A Patients receiving 20 ml Bupivacaine 0.25% added to 1 ml normal saline.
Arms:
Patients receiving Block with Bupivacaine only
Bupivacaine 0.25% Injectable Solution plus Dexmedetomidine
Group B Patients receiving 20 ml Bupivacaine 0.25% added to 1 ml dexmedetomidine
Arms:
Patients receiving Block using Bupivacaine with Dexmedetomidine
Size
60
Primary endpoint
The primary outcome will be the first time to request rescue analgesia.
From the end of the surgery till 24 hours
The primary outcome will be the first time to request rescue analgesia
From the end of the surgery till 24 hours
Eligibility criteria
Inclusion Criteria: * Age:30-65years. * Physical status: ASA I,II. * BMI\<35. * Localized breast cancer Exclusion Criteria: * Age:\<30 and \>65 years. * Refusal of procedure or participation in the study by the patient. * Physical status: ASA III or above. * History of allergy to the study drug. * BMI\>35. * Bleeding disorders and coagulopathy. * Psychiatric illness that may interfere with the study. * Metastatic breast cancer.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2024-02-02

1 organization

2 products

1 indication

Organization
Ain Shams University
Product
Bupivacaine
Indication
Erector Spinae Plane Block
Product
Bupivacaine 0.25% Injectable Solution plus Dexmedetomidine