NCT06725680

Brief Summary

The aim of this study is to compare retrolaminar block and erector spine plane block as opioid-free anesthesia for enhanced recovery after posterior lumbar discectomy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 10, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

December 11, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2025

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

10 months

First QC Date

December 5, 2024

Last Update Submit

November 18, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to the 1st rescue analgesia

    Time from end of surgery to first dose of morphine administrated.

    24 hours postoperatively

Secondary Outcomes (7)

  • Recovery time

    Till first response to verbal command (Up to 1 hour)

  • Time to discharge

    Till the Aldrete score is ≥9 (Up to 3 hours)

  • Intraoperative fentanyl consumption

    Intraoperatively

  • Total morphine consumption

    24 hours postoperatively

  • Degree of pain

    24 hours postoperatively

  • +2 more secondary outcomes

Study Arms (2)

Retrolaminar block group

EXPERIMENTAL

Patients will receive retrolaminar block after the induction of general anesthesia.

Other: Retrolaminar block

Erector spinae plane block group

EXPERIMENTAL

Patients will receive erector spinae plane block after the induction of general anesthesia.

Other: Erector spinae plane block

Interventions

Patients will receive retrolaminar block after the induction of general anesthesia.

Retrolaminar block group

Patients will receive erector spinae plane block after the induction of general anesthesia.

Erector spinae plane block group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age from 18 to 65 years.
  • Both sexes.
  • American Society of Anesthesiology (ASA) physical status I-II.
  • Undergoing elective posterior lumbar discectomy under general anesthesia.

You may not qualify if:

  • Body mass index (BMI) \>35 kg/m2.
  • Patients with disturbed mental status.
  • Allergies to the drugs used in the study.
  • Local infection at the puncture site.
  • Cardiac insufficiency.
  • Renal insufficiency.
  • Coagulopathy.
  • Chronic opioid use.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

First Submitted

December 5, 2024

First Posted

December 10, 2024

Study Start

December 11, 2024

Primary Completion

October 7, 2025

Study Completion

October 7, 2025

Last Updated

November 19, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Locations