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

Not Applicable

Completed

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

• Registration Number: NCT06761079
• Lead Sponsor: Queen Savang Vadhana Memorial Hospital, Thailand

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).

Study Timeline

• Study Start: 2024-01-16
• Primary Completion: 2024-12-16
• Study Completion: 2024-12-25
• Study First Submitted: 2024-12-25
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-04
• Last Update Submitted: 2025-01-04
• Study First Posted: 2025-01-07
• Last Update Posted: 2025-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Queen Savang Vadhana Memorial Hospital; 🇹🇭 Chon Buri, Chonburi, Thailand