Effectiveness of Combining Erector Spinea Block With Non Opioid Infusions as Opioid Free Anesthesia in Spine Surgeries.

Opioid Use Clinical Trial

Official title:

Assistant Professor of Anesthesia, Intensive Care and Pain Management

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05850468
• Other study ID #: MS81/2023
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2023
• Est. completion date: November 2023

Study information

• Verified date: March 2023
• Source: Ain Shams University
• Contact: sanaa wasfy, professor
• Phone: 01061262757
• Email: sanaawasfy[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

opioid free anesthesia consists of combination of pharmacological and non pharmacological modalities that target different pathways of pain mechanism. combining myofascial plane blocks with infusion of adjuvants such as lidocaine or dexmedetomidine can offer equivalent intraoperative hemodynamic stability compared to that of opioid with better pain control postoperatively. this study will investigate the efficacy of combined erector spina block with lidocaine and dexmedetomidine infusion as opioid sparing anesthesia in spine surgeries

Description:

patients who will undergo spine surgery will be allocated into two groups. after general anesthesia, bilateral erector spine block will be applied in both groups. group A will have intraoperative fentanyl infusion and group B will have lidocaine and dexmedetomidine infusion in 50 ml syringe till end of surgery

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: November 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• spine surgery ASAI,II

Exclusion Criteria:

• revision surgery hypotension bradycardia

Related Conditions & MeSH terms

• Opioid Use
• Spine Fusion

Intervention

Drug:
• fentanyl infusion after general anesthesia and erector spinea block
intraoperative opioid infusion in active comparative group
• lidocaine 2% and dextometometidine infusion after general anesthesia and erector spinea block
intraoperative non opioid infusion in experimental group

Locations

Country	Name	City	State
Egypt	Ainshams hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Rowland M, Thomson PD, Guichard A, Melmon KL. Disposition kinetics of lidocaine in normal subjects. Ann N Y Acad Sci. 1971 Jul 6;179:383-98. doi: 10.1111/j.1749-6632.1971.tb46915.x. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients (percentage) having intraoperative systolic hypertension	blood pressure more than 160 mmhg	during operation(intraoperatively)
Primary	number of patients(percentage) having tachycardia	heart rate more than 100 beat /minute	during operation(intraoperatively)
Secondary	VAS score	score from 0 to 10, 0 is no pain and 10 the worst pain	every 30 minutes for 2 hours postoperatively
Secondary	incidence of bradycardia	heart rate less than 45 beat per minute	intraoperatively