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Completed

NCT Number: NCT05312866

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

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

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Key information

Conditions

Opioid Free Anesthesia

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Human Medicine, Zagazig University

Zagazig, Alsharquia, 44511, Egypt

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard analgesia (paracetamol +fentanyl)

Procedure

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

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.

Primary outcomes

  1. The recovery time

    Time frame: 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 outcomes

  1. pain intensity

    Time frame: up to 24 hours postoperative

    pain intensity measured using visual analogue scale from 0= no pain to 10= worst pain

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 6, 2022
Registry last updated
Dec 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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