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Dexmedetomidine in Erector Spinae Block in Postoperative Analgesia

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
erector spinae block with bupivacaine
erector spinae block with bupivacaine + dexmedetomidine
Sponsored by
Mohamed Elsayed Hassan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain focused on measuring Erector spinae block., dexmedetomidine., Postoperative analgesia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • National Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

erector spinae block

erector spinae block + dexmedetomidine

control group

Arm Description

erector spinae block with 20 ml bupivacaine

erector spinae block with 19 ml bupivacaine + dexmedetomidine

standard general anesthesia without any block

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Total morphine consumption in first postoperative 24 hours
The amount of morphine required to relieve pain will be recorded
Intraoperative fentanyl requirement
The amount of fentanyl required during anesthesia will be recorded
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

Full Information

First Posted
May 30, 2021
Last Updated
April 5, 2022
Sponsor
Mohamed Elsayed Hassan
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1. Study Identification

Unique Protocol Identification Number
NCT04920669
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mohamed Elsayed Hassan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Erector spinae block., dexmedetomidine., Postoperative analgesia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
erector spinae block
Arm Type
Experimental
Arm Description
erector spinae block with 20 ml bupivacaine
Arm Title
erector spinae block + dexmedetomidine
Arm Type
Experimental
Arm Description
erector spinae block with 19 ml bupivacaine + dexmedetomidine
Arm Title
control group
Arm Type
No Intervention
Arm Description
standard general anesthesia without any block
Intervention Type
Procedure
Intervention Name(s)
erector spinae block with bupivacaine
Intervention Description
Patients will receive a sonar-guided erector spinae plane block with 20 ml of bupivacaine 0.5%
Intervention Type
Procedure
Intervention Name(s)
erector spinae block with bupivacaine + dexmedetomidine
Intervention Description
Patients will receive a sonar-guided erector spinae plane block with 19 ml of bupivacaine 0.5%+ 1 ml dexmedetomidine
Primary Outcome Measure Information:
Title
Time to first request of analgesia
Description
Time from recovery of anesthesia till first request for analgesia to relive pain.
Time Frame
The first postoperative day
Secondary Outcome Measure Information:
Title
Total morphine consumption in first postoperative 24 hours
Description
The amount of morphine required to relieve pain will be recorded
Time Frame
First 24 postoperative hours
Title
Intraoperative fentanyl requirement
Description
The amount of fentanyl required during anesthesia will be recorded
Time Frame
During anesthesia
Title
Numerical rating scale
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed E Hassan, MD
Organizational Affiliation
National Cancer Institute, Cairo University, Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Institute
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Dexmedetomidine in Erector Spinae Block in Postoperative Analgesia

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