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

NCT06761079 | Completed DMC

• 1 other identifier: 047/2566
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

TLIP block; spine surgery; Thoracolumbar interfascial plane block

Outcome Measures

Primary Outcomes (1)

• 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 (5)

• Pain score (NRS)

  24 hours

• Postoperative nausea and vomiting

  24 hours

• Length of hospital stay

  2 weeks

• Time of the first request for rescue analgesia

  24 hours

• Respiratory depression

  24 hours

Study Arms (2)

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

Thoracolumbar interfascial plane block PROCEDURE

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

TLIP Group

Local anesthetic infiltration PROCEDURE

0.25%bupivacaine infiltration at surgical wound site by orthopedic surgeon

LA Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen Savang Vadhana Memorial Hospital, Thailand: lead

Study Sites (1)

Queen Savang Vadhana Memorial Hospital

Chon Buri, Changwat Chon Buri, 20110, Thailand

Location

MeSH Terms

Conditions

Popliteal Pterygium Syndrome

Study Officials

• Sophitnapa Tanasittiboon, Anesthesiologist

  Queen Savang Vadhana Memorial Hospital, Thailand

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 25, 2024
• First Posted: January 7, 2025
• Study Start: January 16, 2024
• Primary Completion: December 16, 2024
• Study Completion: December 25, 2024
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)