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

Zagazig University

Status: Completed

Conditions: Opioid Free Anesthesia

Treatments: Procedure: Retrolaminar block with bupivacaine + magnesium sulfate + dexamethasone; Procedure: Standard analgesia (paracetamol +fentanyl)

Study type: Interventional

Funder types: Other

Identifiers

NCT05312866

9325

Details and patient eligibility

About

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

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 21 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

72 participants in 2 patient groups

Standard analgesia (paracetamol +fentanyl)

Active Comparator group

Description:

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

Treatment:

Procedure: Standard analgesia (paracetamol +fentanyl)

Retrolaminar block with bupivacaine + magnesium sulfate + dexamethasone

Active Comparator group

Description:

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.

Treatment:

Procedure: Retrolaminar block with bupivacaine + magnesium sulfate + dexamethasone