Comparison of Thoracolumbar Interfascial Plane Block (TLI... | NCT06761079

Studies
Comparison of Thoracolumbar Interfascial Plane Block (TLIP-block) and Local Anesthetic (LA) Infiltration in Minimally Invasive Spine Surgery: A Randomized Controlled Trial

NCT06761079

Sponsor

Queen Savang Vadhana Memorial Hospital, Thailand

Status

Completed

Last Update Posted

Jan 7, 2025Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Percutaneous Pedicular Screw (PPS) Fixation
Minimally Invasive Transforaminal Lumbar Interbody Fusion (MIS TLIF) Surgeries

Interventions

Thoracolumbar interfascial plane block
Local anesthetic infiltration

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 16, 2024Actual

Primary Completion Date

Dec 16, 2024Actual

Completion Date

Dec 25, 2024Actual

First Submitted Date

Dec 25, 2024

First Submission Date that Met QC Criteria

Jan 4, 2025

First Posted Date

Jan 7, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 4, 2025

Last Update Posted Date

Jan 7, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sophitnapa Tanasittiboon, Principal Investigator, Queen Savang Vadhana Memorial Hospital, ThailandPrincipal Investigator

Lead Sponsor

Queen Savang Vadhana Memorial Hospital, ThailandOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this clinical trial is to compare the effectiveness of the thoracolumbar interfascial plane block (TLIP block) versus local anesthetic (LA) infiltration in managing postoperative pain in minimally invasive surgery (MIS) for spine surgery.

The primary outcome was total morphine consumption. Secondary outcomes included pain scores using the the numerical verbal scale (NRS), opioid-related side effects, time of the first request for rescue analgesia, time to ambulation and hospital length of stay.

Detailed Description

A single-center, prospective, double-blind, randomized controlled trial at Queen Savang Vadhana Memorial Hospital.

All 40 enrolled patients were randomized to receive the assigned intervention, Thoracolumbar interfascial plane group (TLIP group) and local anesthetic (LA) infiltration group (LA group).

For TLIP group, patients will receive ultrasound-guild bilateral TLIP block with a total of 40 ml of 0.25% Bupivacaine.
For LA group, patients will receive local anesthetic infiltration with a same drug by orthopedic surgeon.

At the end of surgery, patients were extubated and transferred to the PACU before being shifted to the orthopedic ward.

Postoperative assessments began upon admission to the PACU, designated as time zero, and continued at regular intervals in the orthopedic ward (6-, 8-, 12- and 24-hours post-surgery).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LA Group	Active Comparator	Local anesthetic infiltration (0.25%marcaine 40 ml)	Procedure: Local anesthetic infiltration
TLIP Group	Experimental	Thoracolumbar interfascial plane block with 0.25%marcaine 40 ml under USG	Procedure: Thoracolumbar interfascial plane block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thoracolumbar interfascial plane block	Procedure	Ultrasound-guild bilateral Thoracolumbar interfascial plane block with a total 40 ml, 0.25% bupivacaine by anesthesiologist	TLIP Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total morphine consumption	Total doses of morphine requirement during first 24 hours postoperative period (The investigators recorded at 6,8,12 and 24 hours, postoperatively)	24 hours

Secondary Outcomes

Measure	Description	Time Frame
Pain score (NRS)	The investigators recorded pain score at 6,8,12, 24 hours postoperatively. The scale ranges from 0 to 10, where 0 represents the lowest score and 10 represents the highest score	24 hours
Postoperative nausea and vomiting

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Older than 18 years
American Society of Anesthesiologists classes I-III
Able to use a patient-controlled analgesia (PCA) device
Able to rate their pain using a numerical verbal scale (NRS)

Exclusion Criteria:

Declined to participate
Uncooperative or unable to complete study assessments
Had contraindications to the medications used in the study protocol and regional anesthesia.
History of alcohol or substance abuse within two years prior to surgery,
Allergies to medication used in the study protocol
Pregnancy.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sophitnapa Tanasittiboon, Anesthesiologist	Queen Savang Vadhana Memorial Hospital, Thailand	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Queen Savang Vadhana Memorial Hospital		Chon Buri	Changwat Chon Buri	20110	Thailand

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

Intervention Model Description

Patients will be randomized into two groups using a computer-generated block-of-four randomization sequence. The randomization sequence was generated by independent support staff and concealed using sequentially numbered opaque envelopes. The investigator allocated patients by opening the corresponding envelope to determine group assignment, either to receive the Thoracolumbar interfascial plane block (TLIP group) or the local anesthetic infiltration (LA group). Anesthesiologists, nurses in the Post Anesthesia Care Unit (PACU) and the orthopedic ward staff were blinded to the group allocations.