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

NCT ID: NCT06761079

Last Updated: 2025-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-16

Study Completion Date

2024-12-25

Brief Summary

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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

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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).

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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LA Group

Local anesthetic infiltration (0.25%marcaine 40 ml)

Group Type ACTIVE_COMPARATOR

Local anesthetic infiltration

Intervention Type PROCEDURE

0.25%bupivacaine infiltration at surgical wound site by orthopedic surgeon

TLIP Group

Thoracolumbar interfascial plane block with 0.25%marcaine 40 ml under USG

Group Type EXPERIMENTAL

Thoracolumbar interfascial plane block

Intervention Type PROCEDURE

Ultrasound-guild bilateral Thoracolumbar interfascial plane block with a total 40 ml, 0.25% bupivacaine by anesthesiologist

Interventions

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Thoracolumbar interfascial plane block

Ultrasound-guild bilateral Thoracolumbar interfascial plane block with a total 40 ml, 0.25% bupivacaine by anesthesiologist

Intervention Type PROCEDURE

Local anesthetic infiltration

0.25%bupivacaine infiltration at surgical wound site by orthopedic surgeon

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Queen Savang Vadhana Memorial Hospital, Thailand

OTHER

Sponsor Role lead

Responsible Party

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Sophitnapa Tanasittiboon

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sophitnapa Tanasittiboon, Anesthesiologist

Role: STUDY_DIRECTOR

Queen Savang Vadhana Memorial Hospital, Thailand

Locations

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Queen Savang Vadhana Memorial Hospital

Chon Buri, Changwat Chon Buri, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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047/2566

Identifier Type: -

Identifier Source: org_study_id

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