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Clinical Trials/NCT06761079
NCT06761079
Completed
N/A

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

Queen Savang Vadhana Memorial Hospital, Thailand1 site in 1 country40 target enrollmentJanuary 16, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Percutaneous Pedicular Screw (PPS) Fixation
Sponsor
Queen Savang Vadhana Memorial Hospital, Thailand
Enrollment
40
Locations
1
Primary Endpoint
Total morphine consumption
Status
Completed
Last Updated
last year

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 16, 2024
End Date
December 25, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Queen Savang Vadhana Memorial Hospital, Thailand
Responsible Party
Principal Investigator
Principal Investigator

Sophitnapa Tanasittiboon

Principal Investigator

Queen Savang Vadhana Memorial Hospital, Thailand

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • Length of hospital stay(2 weeks)
  • Pain score (NRS)(24 hours)
  • Postoperative nausea and vomiting(24 hours)
  • Time of the first request for rescue analgesia(24 hours)
  • Respiratory depression(24 hours)

Study Sites (1)

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