Dexmedetomidine in Erector Spinae Block in Postoperative Analgesia

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04920669
• Other study ID #: AP2014-50103
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: August 2021
• Source: National Cancer Institute, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
Egypt	National Cancer Institute	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Mohamed Elsayed Hassan

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first request of analgesia	Time from recovery of anesthesia till first request for analgesia to relive pain.	The first postoperative day
Secondary	Total morphine consumption in first postoperative 24 hours	The amount of morphine required to relieve pain will be recorded	First 24 postoperative hours
Secondary	Intraoperative fentanyl requirement	The amount of fentanyl required during anesthesia will be recorded	During anesthesia
Secondary	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