Dexmedetomidine in Erector Spinae Block in Postoperative Analgesia

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Procedure: erector spinae block with bupivacaine; Procedure: erector spinae block with bupivacaine + dexmedetomidine

• Registration Number: NCT04920669
• Lead Sponsor: Mohamed Elsayed Hassan

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.

Study Timeline

• Study First Submitted: 2021-05-30
• Study First Submitted QC: 2021-06-03
• Study First Posted: 2021-06-10
• Study Start: 2021-07-01
• Status Verified: 2021-08
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Last Update Submitted: 2022-04-05
• Last Update Posted: 2022-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
erector spinae block	erector spinae block with bupivacaine	erector spinae block with 20 ml bupivacaine
erector spinae block + dexmedetomidine	erector spinae block with bupivacaine + dexmedetomidine	erector spinae block with 19 ml bupivacaine + dexmedetomidine

Primary Outcome Measures

Name	Time	Method
Time to first request of analgesia	The first postoperative day	Time from recovery of anesthesia till first request for analgesia to relive pain.

Secondary Outcome Measures

Name	Time	Method
Total morphine consumption in first postoperative 24 hours	First 24 postoperative hours	The amount of morphine required to relieve pain will be recorded
Intraoperative fentanyl requirement	During anesthesia	The amount of fentanyl required during anesthesia will be recorded
Numerical rating scale	The first 24 postoperative hours	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

Trial Locations

Locations (1)

National Cancer Institute; 🇪🇬 Cairo, Egypt