Percutaneous Pedicular Screw (PPS) FixationNCT06761079
Comparison of Thoracolumbar Interfascial Plane Block (TLIP-block) and Local Anesthetic (LA) Infiltration in Minimally Invasive Spine Surgery: A Randomized Controlled Trial
A study testing Thoracolumbar interfascial plane block and Local anesthetic infiltration in people with Percutaneous Pedicular Screw (PPS) Fixation and Minimally Invasive Transforaminal Lumbar Interbody Fusion (MIS TLIF) Surgeries, run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Pedicular Screw (PPS) Fixation, Minimally Invasive Transforaminal Lumbar Interbody Fusion (MIS TLIF) Surgeries
- What is being tested?
- Thoracolumbar interfascial plane block and Local anesthetic infiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- 16 Jan 2024to 25 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Queen Savang Vadhana Memorial Hospital
Chon Buri, Changwat Chon Buri, 20110
About this study
Official title: Comparison of Thoracolumbar Interfascial Plane Block (TLIP-block) and Local Anesthetic 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.
Read the 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).
- Conditions
- Percutaneous Pedicular Screw (PPS) Fixation, Minimally Invasive Transforaminal Lumbar Interbody Fusion (MIS TLIF) Surgeries
- Being tested
- Thoracolumbar interfascial plane block, Local anesthetic infiltration
- Keywords
- TLIP block, spine surgery, Thoracolumbar interfascial plane block
- Medical subject headings
- Popliteal Pterygium Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracolumbar interfascial plane blockProcedure or surgery
Ultrasound-guild bilateral Thoracolumbar interfascial plane block with a total 40 ml, 0.25% bupivacaine by anesthesiologist
Local anesthetic infiltrationProcedure or surgery
0.25%bupivacaine infiltration at surgical wound site by orthopedic surgeon
| Study group | Role | What they receive |
|---|---|---|
| LA Group | Active comparator | Local anesthetic infiltration (0.25%marcaine 40 ml) Receives: Procedure: Local anesthetic infiltration |
| TLIP Group | Experimental | Thoracolumbar interfascial plane block with 0.25%marcaine 40 ml under USG Receives: Procedure: Thoracolumbar interfascial plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 24 hours
Secondary outcomes (5)
Pain score (NRS)
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
Measured: 24 hours
Postoperative nausea and vomiting
The investigators recorded the occurrence of postoperative nausea and vomiting (PONV) as present or absent.
Measured: 24 hours
Length of hospital stay
The investigators recorded the number of hospital days from admission to discharge.
Measured: 2 weeks
Time of the first request for rescue analgesia
Time when a patient first asks for pain relief after their surgery.
Measured: 24 hours
Respiratory depression
The investigators recorded the occurrence of respiratory depression as present or absent.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start16 Jan 2024
- Primary completion16 Dec 2024
- Study completion25 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Pedicular Screw (PPS) FixationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, Thailand
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sophitnapa Tanasittiboon, Queen Savang Vadhana Memorial Hospital, Thailand
- Investigators
- Sophitnapa Tanasittiboon, Anesthesiologist, Study director, Queen Savang Vadhana Memorial Hospital, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761079
- Sponsor's protocol ID
- 047/2566
- Status last verified
- Jan 2025
- First submitted
- 25 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Thoracolumbar Interfascial Plane Block (TLIP-block) and Local Anesthetic Infiltration in Minimally Invasive Spine Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06761079
- Acronym / sponsor ID
- 047/2566
- Conditions
- Percutaneous Pedicular Screw (PPS) Fixation, Minimally Invasive Transforaminal Lumbar Interbody Fusion (MIS TLIF) Surgeries
- Keywords
- TLIP block, spine surgery, Thoracolumbar interfascial plane block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, ThailandUniversity, hospital or other
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 25 Dec 2024 (actual)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| LA Group | Active comparator | Procedure: Local anesthetic infiltrationLocal anesthetic infiltration (0.25%marcaine 40 ml) |
| TLIP Group | Experimental | Procedure: Thoracolumbar interfascial plane blockThoracolumbar interfascial plane block with 0.25%marcaine 40 ml under USG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracolumbar interfascial plane blockUltrasound-guild bilateral Thoracolumbar interfascial plane block with a total 40 ml, 0.25% bupivacaine by anesthesiologist | Procedure or surgery | TLIP Group |
| Local anesthetic infiltration0.25%bupivacaine infiltration at surgical wound site by orthopedic surgeon | Procedure or surgery | LA Group |
Primary outcome
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)
5 secondary outcomes
Pain score (NRS)
Time frame: 24 hours
Postoperative nausea and vomiting
Time frame: 24 hours
Length of hospital stay
Time frame: 2 weeks
Time of the first request for rescue analgesia
Time frame: 24 hours
Respiratory depression
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophitnapa Tanasittiboon, Anesthesiologist study director
Queen Savang Vadhana Memorial Hospital, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracolumbar interfascial plane block and Local anesthetic infiltration in people with Percutaneous Pedicular Screw (PPS) Fixation and Minimally Invasive Transforaminal Lumbar Interbody Fusion (MIS TLIF) Surgeries, run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total morphine consumption (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.