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

NCT05850468 | Unknown

• 1 other identifier: MS81/2023
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Conditions

Opioid Use; Spine Fusion

Keywords

multimodal analgesia, regional blocks, spine surgeries

Outcome Measures

Primary Outcomes (2)

• number of patients (percentage) having intraoperative systolic hypertension

  blood pressure more than 160 mmhg

  during operation(intraoperatively)

• number of patients(percentage) having tachycardia

  heart rate more than 100 beat /minute

  during operation(intraoperatively)

Secondary Outcomes (2)

• VAS score

  every 30 minutes for 2 hours postoperatively

• incidence of bradycardia

  intraoperatively

Study Arms (2)

traditinal balanced anesthesia

ACTIVE COMPARATOR

fentanyl infusion after general anesthesia and erector spinea block

Drug: fentanyl infusion after general anesthesia and erector spinea block

opioid free anesthesia

EXPERIMENTAL

lidocaine and dextometidine infusion after general anesthesia and erector spinea block

Drug: lidocaine 2% and dextometometidine infusion after general anesthesia and erector spinea block

Interventions

fentanyl infusion after general anesthesia and erector spinea block DRUG

intraoperative opioid infusion in active comparative group

Also known as: opioid infusion

traditinal balanced anesthesia

lidocaine 2% and dextometometidine infusion after general anesthesia and erector spinea block DRUG

intraoperative non opioid infusion in experimental group

Also known as: lidocaine 2% and precedex infusion

opioid free anesthesia

Eligibility Criteria

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

You may qualify if:

• \- spine surgery ASAI,II

You may not qualify if:

• revision surgery hypotension bradycardia

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ainshams hospitals

Cairo, 11591, Egypt

Location

Related 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.

  PMID: 5285383 BACKGROUND

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• sanaa wasfy, professor

  assistant professor of anesthesia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

sanaa wasfy, professor

CONTACT

01061262757; sanaawasfy@gmail.com

wael behairy, professor

CONTACT

01282269727; wailbehairy@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2023
• First Posted: May 9, 2023
• Study Start: May 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: November 1, 2023
• Last Updated: May 9, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)