Dexmedetomidine in Erector Spinae Block in Postoperative Analgesia

• Sponsor: Mohamed Elsayed Hassan (Other)
• Overall Status: Completed
• CT.gov ID: NCT04920669
• Collaborator: (none)
• Enrollment: 58
• Location: 1
• Arms: 3
• Actual Duration (Months): 3
• Patients Per Site Per Month: 19.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Procedure: erector spinae block with bupivacaine; Procedure: erector spinae block with bupivacaine + dexmedetomidine	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 58 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Can Dexmedetomidine Improve the Analgesic Duration and Efficacy of Erector Spinae Plane Block in Breast Cancer Surgeries?
• Actual Study Start Date: Jul 1, 2021
• Actual Primary Completion Date: Sep 30, 2021
• Actual Study Completion Date: Sep 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Total morphine consumption in first postoperative 24 hours [First 24 postoperative hours]

   The amount of morphine required to relieve pain will be recorded

2. Intraoperative fentanyl requirement [During anesthesia]

   The amount of fentanyl required during anesthesia will be recorded

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Cancer Institute	Cairo		Egypt

Sponsors and Collaborators

• Mohamed Elsayed Hassan

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohamed Elsayed Hassan, assistant professor of anesthesia and pain relief, National Cancer Institute, Egypt
• ClinicalTrials.gov Identifier: NCT04920669
• Other Study ID Numbers: AP2014-50103
• First Posted: Jun 10, 2021
• Last Update Posted: Apr 6, 2022
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mohamed Elsayed Hassan, assistant professor of anesthesia and pain relief, National Cancer Institute, Egypt: Erector spinae block.; dexmedetomidine.; Postoperative analgesia
• Additional relevant MeSH terms: Pain, Postoperative; Dexmedetomidine; Bupivacaine

Study Results

No Results Posted as of Apr 6, 2022