Percutaneous Pedicular Screw (PPS) Fixation, Minimally Invasive Transforaminal Lumbar Interbody Fusion (MIS TLIF) Surgeries
Conditions
Keywords
TLIP block, spine surgery, Thoracolumbar interfascial plane block
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).
Interventions
Ultrasound-guild bilateral Thoracolumbar interfascial plane block with a total 40 ml, 0.25% bupivacaine by anesthesiologist
PROCEDURELocal anesthetic infiltration
0.25%bupivacaine infiltration at surgical wound site by orthopedic surgeon
Sponsors
Queen Savang Vadhana Memorial Hospital, Thailand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total morphine consumption | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain score (NRS) | 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 |
| Postoperative nausea and vomiting | 24 hours | The investigators recorded the occurrence of postoperative nausea and vomiting (PONV) as present or absent. |
| Length of hospital stay | 2 weeks | The investigators recorded the number of hospital days from admission to discharge. |
| Time of the first request for rescue analgesia | 24 hours | Time when a patient first asks for pain relief after their surgery. |
| Respiratory depression | 24 hours | The investigators recorded the occurrence of respiratory depression as present or absent. |
Countries
Thailand
Outcome results
None listed