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

Opioid Free Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05312866
• Other study ID #: 9325
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: December 1, 2022

Study information

• Verified date: December 2022
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Opioid Free Anesthesia

Intervention

Procedure:
• Standard analgesia (paracetamol +fentanyl)
Patients will receive standard analgesia (paracetamol 15mg/kg plus fentanyl 1ug/kg) iv
• 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.

Locations

Country	Name	City	State
Egypt	Faculty of Human Medicine, Zagazig University	Zagazig	Alsharquia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The recovery time	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.	up to 1 hour postoperative
Secondary	pain intensity	pain intensity measured using visual analogue scale from 0= no pain to 10= worst pain	up to 24 hours postoperative