Intraoperative Retrolaminar Block as Opioid Free Anesthesia After Posterior Lumber Spine Discectomy

NCT05312866 | Completed

• 1 other identifier: 9325
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Opioid-free intraoperative protocols have been successfully used in specific surgical populations with equal or superior results to classic general anesthetic approaches. In instances where opioid-free anesthesia may not be entirely feasible, there exists a continually growing body of evidence that the modern anesthesiologist has a potent pharmacologic and regional anesthetic arsenal that can reduce the amount of opioids required to effectively treat pain. Retrolaminar block is considered a new, easy and simple technique with decreasing incidence of complications such as hypotension, pleural and nerve injury. Its efficacy had been investigated in trauma patients

Conditions

Opioid Free Anesthesia

Outcome Measures

Primary Outcomes (1)

• The recovery time

  The recovery time (time from discontinuation of isoflurane to first response to verbal command) will be recorded, then the patient will be transferred to the post anesthesia care unite (PACU) on standard monitors.

  up to 1 hour postoperative

Secondary Outcomes (1)

• pain intensity

  up to 24 hours postoperative

Study Arms (2)

Standard analgesia (paracetamol +fentanyl)

ACTIVE COMPARATOR

Patients will receive standard analgesia (paracetamol 15mg/kg plus fentanyl 1ug/kg) iv

Procedure: Standard analgesia (paracetamol +fentanyl)

Retrolaminar block with bupivacaine + magnesium sulfate + dexamethasone

ACTIVE COMPARATOR

Patients will receive intraopertative retrolaminar block: 15 ml of bupivacaine 0. 25 % plus 2ml magnesium sulfate 10% (200mg) plus 2ml (8mg) dexamethasone on each side by slipping the needle of injection on the bone of spinous process and lamina.

Procedure: Retrolaminar block with bupivacaine + magnesium sulfate + dexamethasone

Interventions

Standard analgesia (paracetamol +fentanyl) PROCEDURE

Patients will receive standard analgesia (paracetamol 15mg/kg plus fentanyl 1ug/kg) iv

Standard analgesia (paracetamol +fentanyl)

Retrolaminar block with bupivacaine + magnesium sulfate + dexamethasone PROCEDURE

Patients will receive intraopertative retrolaminar block: 15 ml of bupivacaine 0. 25 % plus 2ml magnesium sulfate 10% (200mg) plus 2ml (8mg) dexamethasone on each side by slipping the needle of injection on the bone of spinous process and lamina.

Retrolaminar block with bupivacaine + magnesium sulfate + dexamethasone

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent from the patient.
• Age: 21-60 years old.
• Sex: both sex (males and females).
• American Society of Anesthesiologist Physical status: ASA 1\& II.
• Body Mass Index (BMI) = (25-30 kg/m2).
• Type of operation: elective posterior Lumbar discectomy from L3 to L5 disc space.

You may not qualify if:

• Altered mental state.
• Patients with known history of allergy to study drugs.
• Advanced hepatic, renal, cardiovascular, and respiratory diseases.
• Patients with chronic pain.
• Patients receiving anticoagulants.
• Contraindications of regional anesthesia, e.g., allergy to local anesthetics, coagulopathy, or septic focus at site of injection.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Faculty of Human Medicine, Zagazig University

Zagazig, Alsharquia, 44511, Egypt

Location

MeSH Terms

Interventions

Bupivacaine; Magnesium Sulfate; Dexamethasone

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Alshaimaa Kamel, M.D

  Zagazig University

  PRINCIPAL INVESTIGATOR

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 GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: March 27, 2022
• First Posted: April 6, 2022
• Study Start: May 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 16, 2022

Record last verified: 2022-12

Locations

EG (1)