Dexmedetomidine in Erector Spinae Block in Postoperative Analgesia

NCT04920669 | Completed

• 1 other identifier: AP2014-50103
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Keywords

Erector spinae block.; dexmedetomidine.; Postoperative analgesia

Outcome Measures

Primary Outcomes (1)

• Time to first request of analgesia

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

  The first postoperative day

Secondary Outcomes (3)

• Total morphine consumption in first postoperative 24 hours

  First 24 postoperative hours

• Intraoperative fentanyl requirement

  During anesthesia

• Numerical rating scale

  The first 24 postoperative hours

Study Arms (3)

erector spinae block

EXPERIMENTAL

erector spinae block with 20 ml bupivacaine

Procedure: erector spinae block with bupivacaine

erector spinae block + dexmedetomidine

EXPERIMENTAL

erector spinae block with 19 ml bupivacaine + dexmedetomidine

Procedure: erector spinae block with bupivacaine + dexmedetomidine

control group

NO INTERVENTION

standard general anesthesia without any block

Interventions

erector spinae block with bupivacaine PROCEDURE

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

erector spinae block

erector spinae block with bupivacaine + dexmedetomidine PROCEDURE

Patients will receive a sonar-guided erector spinae plane block with 19 ml of bupivacaine 0.5%+ 1 ml dexmedetomidine

erector spinae block + dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mohamed Elsayed Hassan: lead

Study Sites (1)

National Cancer Institute

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Dexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mohamed E Hassan, MD

  National Cancer Institute, Cairo University, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant professor of anesthesia and pain relief

Study Record Dates

• First Submitted: May 30, 2021
• First Posted: June 10, 2021
• Study Start: July 1, 2021
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: April 6, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)