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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05312866
Enrollment
72
Registered
2022-04-06
Start date
2022-05-01
Completion date
2022-12-01
Last updated
2022-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Free Anesthesia

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.

Interventions

PROCEDUREStandard analgesia (paracetamol +fentanyl)

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

PROCEDURERetrolaminar 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.

Sponsors

Zagazig University
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
The recovery timeup to 1 hour postoperativeThe 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

MeasureTime frameDescription
pain intensityup to 24 hours postoperativepain intensity measured using visual analogue scale from 0= no pain to 10= worst pain

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026