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

Intraoperative Retrolaminar Block as Opioid Free Anesthesia and Enhanced Recovery After Posterior Lumber Spine Discectomy: A Randomized Controlled Study

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

Study Overview

• Status: Completed
• Conditions: Opioid Free Anesthesia
• Intervention / Treatment: Procedure: Standard analgesia (paracetamol +fentanyl); Procedure: Retrolaminar block with bupivacaine + magnesium sulfate + dexamethasone

Detailed Description

• Null hypothesis: Intraoperative retrolaminar block will not produce opioid sparing anesthetic effect and enhanced recovery after posterior lumber spine discectomy.
• Alternative hypothesis: Intraoperative retrolaminar block will produce opioid sparing anesthetic effect and enhanced recovery after posterior lumber spine discectomy.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alsharquia
    • Zagazig, Alsharquia, Egypt, 44511
      • Faculty of Human Medicine, Zagazig University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard analgesia (paracetamol +fentanyl); Patients will receive standard analgesia (paracetamol 15mg/kg plus fentanyl 1ug/kg) iv	Procedure: Standard analgesia (paracetamol +fentanyl); Patients will receive standard analgesia (paracetamol 15mg/kg plus fentanyl 1ug/kg) iv
Active Comparator: Retrolaminar block with bupivacaine + magnesium sulfate + dexamethasone; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain intensity	pain intensity measured using visual analogue scale from 0= no pain to 10= worst pain	up to 24 hours postoperative

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: March 27, 2022
• First Submitted That Met QC Criteria: April 5, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Actual): December 16, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antipyretics; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Analgesics, Opioid; Narcotics; Membrane Transport Modulators; Adjuvants, Anesthesia; Anticonvulsants; Anesthetics, Local; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Dexamethasone; Fentanyl; Acetaminophen; Bupivacaine; Magnesium Sulfate
• Other Study ID Numbers: 9325

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No