Clinical trial NCT06761079: Comparison of Thoracolumbar Interfascial Plane Block (TLIP-block) and Local Anesthetic (LA) Infiltration in Minimally Invasive Spine Surgery: A Randomized Controlled Trial
Official title: Comparison of Thoracolumbar Interfascial Plane Block (TLIP-block) and Local Anesthetic Infiltration in Minimally Invasive Spine Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Percutaneous Pedicular Screw (PPS) Fixation
Minimally Invasive Transforaminal Lumbar Interbody Fusion (MIS TLIF) Surgeries
Keywords: TLIP block
spine surgery
Thoracolumbar interfascial plane block
Lead sponsor: Queen Savang Vadhana Memorial Hospital, Thailand
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Total morphine consumption
timeFrame: 24 hours
Secondary outcomes:
measure: Pain score (NRS)
timeFrame: 24 hours
measure: Postoperative nausea and vomiting
timeFrame: 24 hours
measure: Length of hospital stay
timeFrame: 2 weeks
measure: Time of the first request for rescue analgesia
timeFrame: 24 hours
measure: Respiratory depression
timeFrame: 24 hours
Other outcomes:
Locations:
city: Chon Buri
country: Thailand
facility: Queen Savang Vadhana Memorial Hospital
state: Chonburi
Study officials:
affiliation: Queen Savang Vadhana Memorial Hospital, Thailand
name: Sophitnapa Tanasittiboon, Anesthesiologist
role: STUDY_DIRECTOR
References: