Dexmedetomidine in Erector Spinae Block in Postoperative Analgesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2021-09-30

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.

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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erector spinae block

erector spinae block with 20 ml bupivacaine

Group Type EXPERIMENTAL

erector spinae block with bupivacaine

Intervention Type PROCEDURE

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

erector spinae block + dexmedetomidine

erector spinae block with 19 ml bupivacaine + dexmedetomidine

Group Type EXPERIMENTAL

erector spinae block with bupivacaine + dexmedetomidine

Intervention Type PROCEDURE

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

control group

standard general anesthesia without any block

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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erector spinae block with bupivacaine

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

Intervention Type PROCEDURE

erector 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

Intervention Type PROCEDURE

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No