Regional Block for Postoperative Free Flap Care
Phase: PHASE4
Conditions: Pain Management
Sponsor: University of Alabama at Birmingham

Regional Block for Postoperative Free Flap Care 
 
 
Study Protocol & Statistical Analysis Plan 
 
NCT04080739 
 
Date of Last Protocol Approval 
4/3/2023 
 
 
Anthony Morlandt, MD, Principal Investigator 
University of Alabama at Birmingham 
Birmingham, AL 35294 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Purpose:  
The purpose of this protocol is to evaluate the safety and efficacy of regional anesthesia for head and 
neck patients undergoing microvascular free flap reconstruction. 
 
Background: 
The increasing rate of opioid related overdose mortality is well documented in the literature and 
approached 15 per 100,000 in 2017 (1, 2). Because of a growing epidemic in the US, the medical 
community is under scrutiny to curtail opioid prescription. However, this is weighed against surgical 
outcomes; importantly, postoperative pain has adverse effects on function, recovery and quality of life 
(3, 4, 5).  
 
Regional anesthesia provides a non opioid based, pain control strategy. First, regional anesthesia 
decreases systemic adverse events including respiratory failure in abdominal surgery (6), decreases 
length of stay and improves rehabilitation in common orthopedic procedures such as total knee 
arthroplasty (7) and shoulder arthroplasty (8). Second, the physiologic benefits of regional anesthesia 
are compelling including augmented micro and macrocirculation, maintenance of body temperature and 
decreased systemic stress response through chemical sympathectomy (9, 10). Finally, regional 
anesthesia has been established as safe in the microvascular and anesthesia literature for pediatric (11), 
and adult patients (12, 13). 
 
Participants (Screening and Selection) 
a. How many participants are to be enrolled at UAB (if other sites relying on UAB IRB, list the 
number for each site)? 50 
b. Describe the characteristics of anticipated or planned participants (if multiple groups, 
repeat list for each group). 
Sex: All 
Race/Ethnicity: All 
Age: 18+ 
Health status: All 
c. From what population(s) will the participants be derived? Patients who have presented to 
Departments of Oral and Maxillofacial Surgery and Otolaryngology for evaluation and 
treatment of head and neck disorders requiring free flap reconstruction. 
 
Describe your ability to obtain access to the proposed population that will allow recruitment of 
the necessary number of participants: The PI and sub-Is have practices specifically designated 
for treating head and neck disorders, with potential for enrollment. These patients will be 
identified from individuals treated by the investigators in their clinics. 
 
 
d. Describe the inclusion/exclusion criteria:  
Inclusion criteria: 

• Age > 18 
• Able to consent for themselves 
• Undergoing a head and neck surgery at UAB with reconstruction using either a 
forearm free flap or a fibula free flap 
Exclusion criteria: 
• Age < 18 
• Unable to consent for themselves 
• Non-English speakers 
• Non-resectable tumor 
• Have a known opioid tolerance, or are on a home opioid regimen for a chronic 
condition. (Short-term opioid use for diagnostic procedures (i.e. biopsy) or new 
cancer diagnosis will be allowed).  
• Patients with known hepatic failure, renal failure, or sulfa allergy, as 
determined by standard of care labs drawn within 30 days of enrollment 
 
e. If participants will comprise more than one group or stratification, describe each group (e.g., 
treatment/intervention, placebo, controls, sham treatment) and provide the number of 
participants anticipated in each group. There will be two arms of the study: 
• Control Group (to have 25 participants) will no regional anesthetic pain block 
intraoperatively. Participants will post-operatively receive acetaminophen 650 
mg Q6hr, ibuprofen 400 mg Q6hr if GFR >60, oxycodone 5 mg Q6hr x 2 weeks 
for pain control. This will be our control group. 
• Treatment Group (to have 25 participants) will receive a regional anesthetic 
pain block intraoperatively (US-guided ipsilateral sciatic nerve block for fibula 
free flap patients; US-guided infraclavicular brachial plexus nerve block and 
ropivacaine 0.2% for forearm free lap patients). Participants will post-
operatively receive acetaminophen 650 mg Q6hr, ibuprofen 400 mg Q6hr if 
GFR >60, oxycodone 5 mg Q6hr x 2 weeks for pain control. This will be our 
control group 
 
Procedures: 
Potential participants will be approached during their regularly-scheduled clinic visit about participation 
in the study. Only patients who have already been deemed appropriate surgical candidates prior to 
enrollment will be approached. If they agree to participate, they will sign an informed consent form. 
During this visit, we will collect demographic information, medical history, concomitant medications, 
vital signs, height, and weight.  
Participants will be randomized to one of the two following groups: 
• 
Control Group (to have 25 participants) will no regional anesthetic pain block 
intraoperatively. Participants will post-operatively receive acetaminophen 650 mg Q6hr, 
ibuprofen 400 mg Q6hr if GFR >60, oxycodone 5 mg Q6hr x 2 weeks for pain control. 
This will be our control group. 
• 
Treatment Group (to have 25 participants) will receive a regional anesthetic pain block 
intraoperatively (US-guided ipsilateral sciatic nerve block for fibula free flap patients; 
US-guided infraclavicular brachial plexus nerve block and ropivacaine 0.2% for forearm 
free lap patients). Participants will post-operatively receive acetaminophen 650 mg 

Q6hr, ibuprofen 400 mg Q6hr if GFR >60, oxycodone 5 mg Q6hr x 2 weeks for pain 
control. This will be our control group 
 
Participants will have their scheduled functional endoscopic sinus surgery procedure. Participants 
randomized to the Treatment Group) will receive the appropriate regional anesthetic during the surgery. 
After surgery, participants will be given a pain diary to record their pain score on a scale of 1-10, and a 
place to record their use of opioids, as well as over-the-counter non-steroid anti-inflammatories such as 
acetaminophen and ibuprofen. Participants will record their scores and drug use daily for ten days post-
surgery. At their first post-operative clinic visit, the diary will be reviewed, and their opioid use will also 
be evaluated by counting the pills left on their prescription. 
 
Data points/variables to be collected during the study could include the following, to be ascertained 
from the medical record and/or patient report:  
• 
Name 
• 
Medical Record Number 
• 
Age 
• 
Gender 
• 
Medications given by anesthesia intra- and post-operatively 
• 
Post-operative pain medication used prior to and after discharge 
• 
Post-operative complications 
• 
Post-discharge/post-operative pain evaluation by patient diary 
 
Benefits: 
Benefits of this research include using a more effective and less risky pain regimen for head and neck 
surgery patients. We propose that the new pain regimen will result in better pain control and result in 
less opioid pain medication usage which would be safer for patients. 
 
Risks: 
There will be no additional clinical or surgical risks other than the normal risks for patients in this 
population undergoing this type of treatment. 
There is a risk of randomization associated with this protocol, in that the treatment for the treatment 
group may prove less effective or have more side effects than the control group.  
Though both the treatment group and the control group will receive be prescribed the exact same 
amount of opioid medication for use for post-operative surgical pain, there is a chance that the control 
group will use more of the medication than the treatment group for relief of their post-surgical pain. 
 
Statistical Analysis Plan: 
All statistical analyses will be completed using SPSS software, version 28 (SPSS Inc., Chicago, IL). For all 
tests, the statistical significance will be set at P values of <.05. 
 

References: 
 
1. Bohnert AS, Valenstein M, Bair MJ, et al. Association between opioid prescribing patterns and 
opioid overdose-related deaths. JAMA. 2011;305(13):1315-21. 
 
2. Scholl L, Seth P, Kariisa M, Wilson N, Baldwin G. Drug and Opioid-Involved Overdose Deaths - 
United States, 2013-2017. MMWR Morb Mortal Wkly Rep. 2018;67(5152):1419-1427. 
 
3. Gan TJ. Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain 
Res. 2017;10:2287-2298. 
 
4. Wu CL, Naqibuddin M, Rowlingson AJ, Lietman SA, Jermyn RM, Fleisher LA. The effect of pain 
on health-related quality of life in the immediate postoperative period. Anesth Analg. 
2003;97(4):1078-85, table of contents. 
 
5. Peters ML, Sommer M, De rijke JM, et al. Somatic and psychologic predictors of long-term 
unfavorable outcome after surgical intervention. Ann Surg. 2007;245(3):487-94. 
 
6. Rigg JR, Jamrozik K, Myles PS, et al. Epidural anaesthesia and analgesia and outcome of major 
surgery: a randomised trial. Lancet. 2002;359(9314):1276-82. 
 
7. Macfarlane AJ, Prasad GA, Chan VW, Brull R. Does regional anesthesia improve outcome after 
total knee arthroplasty?. Clin Orthop Relat Res. 2009;467(9):2379-402. 
 
8. Warrender WJ, Syed UAM, Hammoud S, et al. Pain Management After Outpatient Shoulder 
Arthroscopy: A Systematic Review of Randomized Controlled Trials. Am J Sports Med. 
2017;45(7):1676-1686. 
 
9. Macdonald DJ. Anaesthesia for microvascular surgery. A physiological approach. Br J Anaesth. 
1985;57(9):904-12. 
 
10. Hahnenkamp K, Theilmeier G, Van aken HK, Hoenemann CW. The effects of local anesthetics 
on perioperative coagulation, inflammation, and microcirculation. Anesth Analg. 2002;94(6):1441-
7. 
 

11. Bjorklund KA, Venkatramani H, Venkateshwaran G, Boopathi V, Raja sabapathy S. Regional 
anesthesia alone for pediatric free flaps. J Plast Reconstr Aesthet Surg. 2015;68(5):705-8. 
 
12. Parikh RP, Sharma K, Guffey R, Myckatyn TM. Preoperative Paravertebral Block Improves 
Postoperative Pain Control and Reduces Hospital Length of Stay in Patients Undergoing 
Autologous Breast Reconstruction after Mastectomy for Breast Cancer. Ann Surg Oncol. 
2016;23(13):4262-4269. 
 
13. Ruan QZ, Diamond S, Zimmer S, Iorio ML. Assessing the Safety and Efficacy of Regional 
Anesthesia for Lower Extremity Microvascular Reconstruction: Enhancing Recovery. J Reconstr 
Microsurg. 2018;34(4):293-299.