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?

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: erector spinae block with bupivacaine; Procedure: erector spinae block with bupivacaine + dexmedetomidine

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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • National Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mohamed Elsayed Hassan
• Investigators: Principal Investigator: Mohamed E Hassan, MD, National Cancer Institute - Cairo University - Egypt

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: May 30, 2021
• First Submitted That Met QC Criteria: June 3, 2021
• First Posted (Actual): June 10, 2021

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: April 5, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Postoperative analgesia; Erector spinae block.; dexmedetomidine.
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Anesthetics, Local; Dexmedetomidine; Bupivacaine
• Other Study ID Numbers: AP2014-50103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No