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Dexmedetomidine in Erector Spinae Block in Postoperative Analgesia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04920669
Enrollment
58
Registered
2021-06-10
Start date
2021-07-01
Completion date
2021-09-30
Last updated
2022-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

Erector spinae block., dexmedetomidine., Postoperative analgesia

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.

Interventions

Patients will receive a sonar-guided erector spinae plane block with 20 ml of bupivacaine 0.5%

PROCEDUREerector spinae block with bupivacaine + dexmedetomidine

Patients will receive a sonar-guided erector spinae plane block with 19 ml of bupivacaine 0.5%+ 1 ml dexmedetomidine

Sponsors

Mohamed Elsayed Hassan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Time to first request of analgesiaThe first postoperative dayTime from recovery of anesthesia till first request for analgesia to relive pain.

Secondary

MeasureTime frameDescription
Total morphine consumption in first postoperative 24 hoursFirst 24 postoperative hoursThe amount of morphine required to relieve pain will be recorded
Intraoperative fentanyl requirementDuring anesthesiaThe amount of fentanyl required during anesthesia will be recorded
Numerical rating scaleThe first 24 postoperative hoursNumerical 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026