The goal of this clinical trial is to assess how the location of local anesthetic medication affects pain control capabilities in adult patients undergoing thoracic(chest)-only minimally invasive surgery. The main questions it aims to answer are:
* Is pain decreased when local analgesia is provided as a combination of serratus anterior plane block and intercostal nerve block when compared to either block administered individually? * How does location of local analgesia administration impact length-of-stay, cost-of-care, and quality-of-life?
Researchers will compare three treatment options including long-acting local anesthetic (Exparel®) administered as (1) intercostal nerve block, (2) serratus anterior plane block, or (3) combination of intercostal nerve block and serratus anterior plane block to see if pain and opioid use are reduced dependent upon treatment group.
All participants will receive a local anesthetic nerve block. Participants will be asked to describe their pain after surgery and to answer various questionnaires before and after surgery.
Plan to undergo planned (elective) minimally invasive isolated R-VATS procedure, to include pulmonary anatomic resections (anatomic lobectomy, segmentectomy, and wedge resection if performed robotically)
Age ≥ 18 years old
Ability to understand and capacity/willingness to sign a written informed consent form
Age < 18 years old
Unwilling to sign informed consent form, mentally challenged/delayed, or lacking capacity/unable to consent to participation in the trial own their own behalf
Vulnerable populations
Incarcerated individuals
Parallel
Arm 1 "LipoB-I": Liposomal Bupivacaine via Multi-Level Intercostal Nerve Block
Procedure/SurgeryThe anesthetic mixture is prepared by combining 266 mg (20 mL) of Liposomal Bupivacaine (Exparel®) with 50 mg (20 mL) of 0.25% Bupivacaine Hydrochloride, creating a mixture of 40 mL. This mixture is administered via multi-level intercostal nerve block (ICNB). One injection is administered by a surgeon per intercostal space (ICS), given at the origin of the nerve space junction where the nerve and the inferior aspect of the rib meet after the nerve immerges from the intervertebral foramina. At least 5 mL, and no more than 8mL, will be injected in each ICS with the ideal injection consisting of 3 mL just beneath the pleura and 5 mL deeper in the intercostal muscular tissue for a total of 8 mL per ICS. Injections will be completed utilizing a 21-guage needle and two 20-mL syringes.
Arm 2 "LipoB-S": Liposomal Bupivacaine via Serratus Anterior Plane Block
Procedure/SurgeryThe anesthetic mixture is prepared by combining 266 mg (20 mL) of Liposomal Bupivacaine (Exparel®) with 50 mg (20 mL) of 0.25% Bupivacaine Hydrochloride, creating a mixture of 40 mL. This mixture is administered via serratus anterior plane block. One injection is administered by an anesthesiologist in the serratus anterior fascial plane, immediately prior to incision while in the operating room. The total volume of 40 mL is administered using a single-shot technique with a short-bevel, 21-guage needle, ensuring a negative aspiration for blood upon entry, no paresthesia on injection, and incremental injection under ultrasound guidance.
Arm 3 "LipoB-C": Liposomal Bupivacaine Administered via Combination Block
Procedure/SurgeryPatients randomized to Arm 3 will receive both a multi-level intercostal nerve block (ICNB) and a serratus anterior plane block (SAPB), with each containing half the dose of Liposomal Bupivacaine (LipoB) as compared to when administered as a single block in Arm 1 and Arm 2. The mixtures are as follows: 133mg (10mL) LipoB mixed with 25mg (10mL) 0.25% Bupivacaine Hydrochloride and 20mL of saline administered as SAPB by anesthesiologist immediately prior to incision while in the operating room AND 133mg (10mL) LipoB mixed with 25mg (10mL) 0.25% Bupivacaine Hydrochloride and 20mL of saline administered as ICNB prior to closure in at least 5 intercostal spaces as determined by administering surgeon, while in the operating room.
NRS AUC 72
The investigators will obtain the NRS NRS AUC 72 (units: NRS·hours) (units 0-10) from time 0, entry into the recovery room, to 72 hours after entry into the recovery room. Pain will be assessed by the nursing staff, typically every 4 hours, and by research staff at least once on post-operative days 1-3. The times t0,t1,…,tk in hours within the range of 0 to 72 hours will correspond to NRS scores y0,y1,…,yk. Using the trapezoidal rule over the observed interval (assuming irregular and irregular timing), where: AUC=∑i((yi+yi+1)/2)(ti+1-ti), the maximum NRS·hours would be 10 x 72 hours + 720. If an individual patient measurement is taken off-schedule, the actual time stamps will be utilized. The trapezoidal rule naturally accommodates irregular spacing. If a patient is discharged early, or there is missing data, the AUC will be computed over the observed intervals and reported as time-standardized AUC = (AUC over observed time)/observed hours x 72.
Numeric Rating Scale (NRS)
A pain numeric rating scale will be administered to all patients in the trial from post-operative day 0 to post-operative day 3 in the hospital. Study personnel will gather a NRS value once a day for post-operative day 1-3 and nursing staff will gather a NRS value multiple times a day, typically every 4 hours, per their protocol. Average and maximum values (Likert scale 0-10) will be recorded each day.
Quality-of-Life (Measured by Quality of Recovery Scale)
Investigators will measure post-operative side effects, functional status, and quality-of-life using the Quality of Recovery 15 scale (QR-15). The QR-15 scale measures pain as well as patient daily functioning, enjoyment, relationships, and overall well-being. The QR-15 has previously been validated among the minimally-invasive Thoracic Surgery population, with large-scale studies demonstrating significantly different medial QR-15 scores before to after surgery, with the QR-15 showing significant negative correlations with pain intensity and during coughing in the post-operative period. Further, the pain dimension of the QR-15 correlated to patient "emotional state, physical comfort, and physical independence" at 24, 48, and 72 hours post-operatively. QR-15 may assess nausea, appetite, constipation, and fatigue levels, as well as return to baseline function including return to oral intake, bowel function and ambulation. This scale is favored in clinical use by many anesthesiologists.
Pain Interference via PROMIS Pain Interference (PROMIS-PI)
The PROMIS Pain Interference item banks assess self-reported consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Pain Interference also incorporates items probing sleep and enjoyment in life, though the item bank only contains one sleep item. The pain interference short forms are universal rather than disease-specific. All assess pain interference over the past seven days.
Quality of Sleep via PROMIS Sleep Disturbance Short Form (SF)
The PROMIS Sleep Disturbance-SF questionnaire will be administered on post-operative day 1, as well as during clinic and telephone follow-up. This questionnaire assesses overall quality of sleep.
Opioid Usage
All opioid usage-including medication type, dosage, and time of administration- will be documented in the medical record. Opioid usage will be converted in a standard fashion to morphine milligram equivalents (MME) per day which will be recorded for all patients. Total cumulative opioid consumption will also be noted. This data will allow the research team to note time until first opioid use after surgery, time until cessation of opioid use after surgery, and whether a patient is utilizing opioids at time of discharge.
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University of Texas Southwestern Medical Center
Lead sponsor
The University of Texas at Dallas
Collaborator
Simmons Cancer Center
Collaborator
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