Clinical trial NCT04920669: Dexmedetomidine in Erector Spinae Block in Postoperative Analgesia
Official title: Can Dexmedetomidine Improve the Analgesic Duration and Efficacy of Erector Spinae Plane Block in Breast Cancer Surgeries?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Erector spinae block.
dexmedetomidine.
Postoperative analgesia
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Time to first request of analgesia
timeFrame: The first postoperative day
Secondary outcomes:
measure: Total morphine consumption in first postoperative 24 hours
timeFrame: First 24 postoperative hours
measure: Intraoperative fentanyl requirement
timeFrame: During anesthesia
measure: Numerical rating scale
timeFrame: The first 24 postoperative hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Cancer Institute
Study officials:
affiliation: National Cancer Institute, Cairo University, Egypt
name: Mohamed E Hassan, MD
role: PRINCIPAL_INVESTIGATOR
References: