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

Z

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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