Dexmedetomidine in Erector Spinae Block in Postoperative Analgesia

Study Overview
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Brief Summary
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60 female patients scheduled for breast cancer surgeries, allocated in 3 groups for erector spinae block with bupivacaine and erector spinae block with dexmedetomidine added to bupivacaine and control group. During anesthesia: total intraoperative fentanyl required will be recorded. After surgery the first time of request for analgesic will be recorded. after request of analgesia all patients will be connected to PCA device containing morphine solution, the amount of morphine consumed during the first 24 hours will be recorded.

Detailed Description
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60 female patients scheduled for breast cancer surgeries, allocated in 3 groups for erector spinae block with bupivacaine and erector spinae block with dexmedetomidine added to bupivacaine and control group. During anesthesia: total intraoperative fentanyl required will be recorded. After surgery the first time of request for analgesic will be recorded. after request of analgesia all patients will be connected to PCA device containing morphine solution, the amount of morphine consumed during the first 24 hours will be recorded. Other secondary outcomes are numerical rating scales and incidence of opioid side effects.

Official Title
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Can Dexmedetomidine Improve the Analgesic Duration and Efficacy of Erector Spinae Plane Block in Breast Cancer Surgeries?

Conditions
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Postoperative Pain

Intervention / Treatment
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* Procedure: erector spinae block with bupivacaine
* Procedure: erector spinae block with bupivacaine + dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Female, aged (18-70) years Belongs to American Society of Anaesthesiologists physical status class II. Scheduled for breast cancer surgeries. Exclusion Criteria: Patient refusal. Local infection at the site of the block. Cardiac dysfunction (ejection fraction <45%). Preexisting neurological or psychiatric disease, communication difficulties, inability to use the patient-controlled analgesia (PCA) device. Allergy to one of the study drugs. Pregnancy. Coagulopathy (PC <60% and platelet count<100.000).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: erector spinae block<br>erector spinae block with 20 ml bupivacaine | Procedure: erector spinae block with bupivacaine<br>* Patients will receive a sonar-guided erector spinae plane block with 20 ml of bupivacaine 0.5%<br>|
| Experimental: erector spinae block + dexmedetomidine<br>erector spinae block with 19 ml bupivacaine + dexmedetomidine | Procedure: erector spinae block with bupivacaine + dexmedetomidine<br>* Patients will receive a sonar-guided erector spinae plane block with 19 ml of bupivacaine 0.5%+ 1 ml dexmedetomidine<br>|
| No Intervention: control group<br>standard general anesthesia without any block | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first request of analgesia | Time from recovery of anesthesia till first request for analgesia to relive pain. | The first postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total morphine consumption in first postoperative 24 hours | The amount of morphine required to relieve pain will be recorded | First 24 postoperative hours | 
| Intraoperative fentanyl requirement | The amount of fentanyl required during anesthesia will be recorded | During anesthesia | 
| Numerical rating scale | Numerical rating scale (from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain) will be recorded in different time intervals during the first 24 hours after surgery | The first 24 postoperative hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erector spinae block., dexmedetomidine., Postoperative analgesia