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

Not Applicable

Not yet recruiting

• Conditions: Opioid Use; Spine Fusion
• Interventions: Drug: fentanyl infusion after general anesthesia and erector spinea block; Drug: lidocaine 2% and dextometometidine infusion after general anesthesia and erector spinea block

• Registration Number: NCT05850468
• Lead Sponsor: Ain Shams University

Brief 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

Detailed 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

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-18
• Study First Submitted QC: 2023-04-29
• Last Update Submitted: 2023-04-29
• Study Start: 2023-05
• Study First Posted: 2023-05-09
• Last Update Posted: 2023-05-09
• Primary Completion: 2023-10
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• spine surgery ASAI,II

Exclusion Criteria

• revision surgery hypotension bradycardia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
traditinal balanced anesthesia	fentanyl infusion after general anesthesia and erector spinea block	fentanyl infusion after general anesthesia and erector spinea block
opioid free anesthesia	lidocaine 2% and dextometometidine infusion after general anesthesia and erector spinea block	lidocaine and dextometidine infusion after general anesthesia and erector spinea block

Primary Outcome Measures

Name	Time	Method
number of patients (percentage) having intraoperative systolic hypertension	during operation(intraoperatively)	blood pressure more than 160 mmhg
number of patients(percentage) having tachycardia	during operation(intraoperatively)	heart rate more than 100 beat /minute

Secondary Outcome Measures

Name	Time	Method
VAS score	every 30 minutes for 2 hours postoperatively	score from 0 to 10, 0 is no pain and 10 the worst pain
incidence of bradycardia	intraoperatively	heart rate less than 45 beat per minute

Trial Locations

Locations (1)

Ainshams hospitals; 🇪🇬 Cairo, Egypt