NCT04920669 - Dexmedetomidine in Erector Spinae Block in Postoperative Analgesia | Crick

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

58

Conditions

Postoperative Pain

Interventions

erector spinae block with bupivacainePROCEDURE

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

erector spinae block with bupivacaine + dexmedetomidinePROCEDURE

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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).

Locations (1)

National Cancer Institute

Cairo, Egypt

Outcomes

Primary Outcomes

Time to first request of analgesia

Time from recovery of anesthesia till first request for analgesia to relive pain.

Time frame: The first postoperative day

Secondary Outcomes

Total morphine consumption in first postoperative 24 hours

The amount of morphine required to relieve pain will be recorded

Time frame: First 24 postoperative hours

Intraoperative fentanyl requirement

The amount of fentanyl required during anesthesia will be recorded

Time frame: 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

Time frame: The first 24 postoperative hours