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

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

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.

Study Overview

• Status: Completed
• Conditions: Percutaneous Pedicular Screw (PPS) Fixation; Minimally Invasive Transforaminal Lumbar Interbody Fusion (MIS TLIF) Surgeries
• Intervention / Treatment: Procedure: Local anesthetic infiltration; Procedure: Thoracolumbar interfascial plane block

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).

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Chonburi
    • Chon Buri, Chonburi, Thailand, 20110
      • Queen Savang Vadhana Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: LA Group; Local anesthetic infiltration (0.25%marcaine 40 ml)	Procedure: Local anesthetic infiltration; 0.25%bupivacaine infiltration at surgical wound site by orthopedic surgeon
Experimental: TLIP Group; Thoracolumbar interfascial plane block with 0.25%marcaine 40 ml under USG	Procedure: Thoracolumbar interfascial plane block; Ultrasound-guild bilateral Thoracolumbar interfascial plane block with a total 40 ml, 0.25% bupivacaine by anesthesiologist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	The investigators recorded the occurrence of postoperative nausea and vomiting (PONV) as present or absent.	24 hours
Length of hospital stay	The investigators recorded the number of hospital days from admission to discharge.	2 weeks
Time of the first request for rescue analgesia	Time when a patient first asks for pain relief after their surgery.	24 hours
Respiratory depression	The investigators recorded the occurrence of respiratory depression as present or absent.	24 hours

Collaborators and Investigators

• Sponsor: Queen Savang Vadhana Memorial Hospital, Thailand
• Investigators: Study Director: Sophitnapa Tanasittiboon, Anesthesiologist, Queen Savang Vadhana Memorial Hospital, Thailand

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2024
• Primary Completion (Actual): December 16, 2024
• Study Completion (Actual): December 25, 2024

Study Registration Dates

• First Submitted: December 25, 2024
• First Submitted That Met QC Criteria: January 4, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 4, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: spine surgery; TLIP block; Thoracolumbar interfascial plane block
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: 047/2566

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes