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

Not Applicable

Completed

• Conditions: Opioid Free Anesthesia
• Interventions: Procedure: Retrolaminar block with bupivacaine + magnesium sulfate + dexamethasone; Procedure: Standard analgesia (paracetamol +fentanyl)

• Registration Number: NCT05312866
• Lead Sponsor: Zagazig University

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

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 Timeline

• Study First Submitted: 2022-03-27
• Study First Submitted QC: 2022-04-05
• Study First Posted: 2022-04-06
• Study Start: 2022-05-01
• Status Verified: 2022-12
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01
• Last Update Submitted: 2022-12-13
• Last Update Posted: 2022-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Retrolaminar block with bupivacaine + magnesium sulfate + dexamethasone	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.
Standard analgesia (paracetamol +fentanyl)	Standard analgesia (paracetamol +fentanyl)	Patients will receive standard analgesia (paracetamol 15mg/kg plus fentanyl 1ug/kg) iv

Primary Outcome Measures

Name	Time	Method
The recovery time	up to 1 hour postoperative	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.

Secondary Outcome Measures

Name	Time	Method
pain intensity	up to 24 hours postoperative	pain intensity measured using visual analogue scale from 0= no pain to 10= worst pain

Trial Locations

Locations (1)

Faculty of Human Medicine, Zagazig University; 🇪🇬 Zagazig, Alsharquia, Egypt