Transcutaneous Electrical Nerve Stimulation Reduces Movement-Evoked Pain and Fatigue: A Randomized, Controlled Trial.
Dana L Dailey, Carol G T Vance, Barbara A Rakel...
https://pubmed.ncbi.nlm.nih.gov/31738014/Actively Recruiting
Led by University of Iowa · Updated on 2026-03-27
50
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating the use of thoracolumbar interfascial plane TLIP blocks in older adults undergoing spinal fusion surgery. This early phase study aims to test the feasibility of implementing TLIP blocks, which involve anesthesia applied to the back near the surgery site. The goal is to gather information on recruitment, assessment completion, dropout rates, patient feedback, and potential barriers to using TLIP blocks. This feasibility study will also help plan a larger randomized trial to assess the impact of TLIP blocks on pain, physical function, opioid use, and delirium in this population. Participants will be randomly assigned to one of two groups one receiving standard anesthesia care without TLIP blocks, and the other receiving standard anesthesia plus a TLIP block with bupivacaine during surgery. The TLIP block is given after anesthesia but before spinal fusion. The study includes various questionnaires and assessments related to pain, anxiety, depression, disability, delirium, and cognitive function. Blood tests will measure inflammation markers before and after surgery. During the study, participants will complete multiple assessments from before surgery up to 12 weeks post-operation, including pain scores, mental health evaluations, and delirium severity ratings. Researchers will monitor opioid use, side effects, hospital stay length, readmission rates, and disposition to care facilities over 16 months. The study will also collect patient-reported adverse events and use several detailed questionnaires to measure recovery and function after surgery.
CONDITIONS
Regional Nerve Blocks to Improve Analgesia and Recovery in Older Adults Undergoing Spinal Fusion
A
Alex R Coffman, BS
C
Catherine R Olinger, MD
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University of Iowa
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Standard anesthesia with TLIP block (bupivacaine) | Standard anesthesia without TLIP block |
|---|---|---|
| What it is | Intraoperative regional nerve block (TLIP) with bupivacaine is added to standard anesthesia to manage pain during and after spinal fusion surgery. | Participants receive standard general anesthesia for elective lumbar spinal fusion without an added nerve block. |
| Role in the trial | Investigational group: assesses whether adding TLIP block improves pain control, opioid use, delirium rates, and recovery. | Active comparator: evaluates routine anesthesia practice without regional blocks for this surgery. |
| Primary use | Used to test if regional nerve block can reduce postoperative pain and complications, especially delirium, in older adults. | Serves as a basis to compare the effectiveness of nerve blocks and track outcomes under usual perioperative care conditions. |
| How it is given or performed | TLIP block with bupivacaine is injected under anesthesia before surgical incision for spinal fusion. | Patients receive standard anesthesia without a nerve block for the procedure. |
| Evidence status | Recent clinical studies and meta-analyses suggest TLIP blocks may reduce postoperative pain and opioid consumption after spine surgery, with variability in impact on delirium or recovery time. | Standard general anesthesia alone provides variable postoperative pain control and may require higher opioid use; it is associated with typical rates of postoperative delirium and recovery outcomes for this type of surgery. |
| Important limitations | Effectiveness of TLIP block can vary due to differences in technique, patient anatomy, and limited data in the oldest adult populations; rare risks include local anesthetic complications. | Standard anesthesia without a nerve block may result in higher pain levels, increased need for opioids, and potentially greater risk of delirium after surgery in older adults. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day plus hospital stay
Participants undergo lumbar spinal fusion surgery and receive either standard anesthesia alone or with an additional regional nerve block called the Thoracolumbar Interfascial Plane (TLIP) Block of bupivacaine during surgery.
1 surgical visit and hospital stay
Duration - Up to 12 weeks post-operatively
Participants are monitored for pain, cognitive function, opioid use, and recovery through questionnaires and blood tests after surgery.
Weekly visits for up to 12 weeks
Duration - Up to 16 months post-operatively
Participants are observed for longer-term outcomes including hospitalization length, readmission, and disposition to skilled facilities.
Periodic follow-up contacts during 16 months
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/31787005/University of Iowa
Lead Sponsor