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Completed

NCT Number: NCT06761079

Comparison of Thoracolumbar Interfascial Plane Block (TLIP-block) and Local Anesthetic (LA) 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Savang Vadhana Memorial Hospital

Chon Buri, Changwat Chon Buri, 20110, Thailand

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thoracolumbar interfascial plane block

Procedure

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

local anesthetic infiltration

Procedure

0.25%bupivacaine infiltration at surgical wound site by orthopedic surgeon

Primary outcomes

  1. Total morphine consumption

    Time frame: 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 outcomes

  1. Pain score (NRS)

    Time frame: 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

  2. Postoperative nausea and vomiting

    Time frame: 24 hours

    The investigators recorded the occurrence of postoperative nausea and vomiting (PONV) as present or absent.

  3. Length of hospital stay

    Time frame: 2 weeks

    The investigators recorded the number of hospital days from admission to discharge.

  4. Time of the first request for rescue analgesia

    Time frame: 24 hours

    Time when a patient first asks for pain relief after their surgery.

  5. Respiratory depression

    Time frame: 24 hours

    The investigators recorded the occurrence of respiratory depression as present or absent.

Sponsors and collaborators

Lead sponsor

Queen Savang Vadhana Memorial Hospital, Thailand

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 7, 2025
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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