Clinical trial NCT02280291
Conditions: Pain Fracture
Sponsor: NYU Langone Health
Start date: 2013-08-01; Completion date: 2018-12-13
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Peripheral nerve blocks have been well studied in the literature with generally good results for controlling post operative pain following orthopaedic surgery. Regional anesthesia has many benefits. It provides excellent intraoperative anesthesia and muscle relaxation as well as analgesia that continues into the post-operative period. These regional blocks are also effective in controlling pain in the immediate post-operative period. However, as the block wears off, patients begin experiencing increased pain. Compared to patients treated without regional blocks, these patients will often experience a "rebound pain"--pain occurring 12-24 hours after surgery that is subjectively worse than that in patients treated without regional blocks. Therefore, the investigators propose to use a continuous infusion of anesthetic in order to provide sustained pain control post-operatively. Preoperatively, patients will be randomized into a single shot peripheral nerve block versus a continuous infusion of peripheral nerve block. Post-operatively, pain will be assessed using the Visual Analogue Scale (1-100) prior to being discharged from PACU. Time to discharge and amount of pain medication taken will be recorded. Patients will be contacted at certain time intervals postoperatively to assess their pain scale and pain medication intake. Patients will be seen for routine post-operative follow-up visits where they will be assessed for satisfaction, pain, residual neurological symptoms, and signs of infection.

Detailed description:
Purpose The purpose of this randomized prospective study will be to compare post-operative pain control after extremity fracture fixation surgery between patients who receive single shot versus continuous peripheral nerve blocks.

Scientific or Scholarly Rationale Peripheral nerve blocks have been well studied in the literature with generally good results for controlling post operative pain following orthopaedic surgery 1-4. Regional anesthesia has many benefits. It provides excellent intraoperative anesthesia and muscle relaxation as well as analgesia that continues into the post-operative period. Airway manipulations are avoided, post-operative nausea and vomiting are diminished, post-anesthesia care unit stay are shortened, and fewer nursing interventions in the post-anesthesia care unit are required5-6.

Patients who have operative fixation of extremity fractures (ankle, wrist, forearm) are typically ambulatory patients. However, many become hospitalized overnight secondary to inadequate pain control, increasing hospital costs. Goldstein et al. showed that patients who underwent popliteal blocks after ankle fracture fixation demonstrated significantly better pain control immediately postoperatively7. The need for overnight hospitalization secondary to pain is decreased, as are nonsurgical operating room times.

Despite the success of regional anesthesia, a phenomenon known as "rebound pain" has been shown to occur as the original block wears off7-9. Patients with blocks will experience significantly increased pain compared to those without blocks approximately 12-24 hours after surgery. This can be controlled with early narcotic administration but can be a source of significant discomfort to a patient if not recognized and treated in time. A few studies have shown that continuous infusions of various numbing agents are efficacious in prolonged pain control, even in the ambulatory setting10-12. Nevertheless, no studies have thus performed a randomized prospective control trial studying the efficacy of continuous infusion therapy on pain control following extremity fracture surgery.

Aims

1. To determine the effectiveness of continuously infused regional anesthetic for pain control in extremity fracture surgery
2. To determine the effect of rebound pain on patient satisfaction of surgery Description of study and study procedure Consent All patients being treated with open reduction internal fixation for foot, ankle, tibia, elbow, forearm and wrist fractures at New York University Medical Center, NYU-Hospital for Joint Diseases will be asked to participate in this study. At the patients preoperative office visit, they will be asked to participate in the study and provided a copy of the consent form at that time which they can take home with them. All questions will be answered and they will be asked verbally if they will consent to being a part of the study. Patients will then have the opportunity to either sign the written consent forms or wait till the surgical date to think about the study and any additional questions they may have. At the time of surgery, patients will be consented for surgery. If the patient did not give written consent at the preoperative visit, they will be asked if they have any questions about the study. All questions will again be answered. They will then be asked verbally if they are willing to participate in the study, if they respond yes, then written consent will be obtained at that time.

Randomization Patients will then be randomized (using an online randomizer, similar to a flip of a coin) to one of two anesthetic protocols: regional block with single dose of anesthetic versus regional block with continuous infusion using an OnQ pump. If for some reason, the anesthesiologist feels that a patient would benefit from one type of anesthesia over another, the patient will be removed from the study and given that type of anesthesia.

Intervention Patients will be randomized to one of two anesthetic protocols: general anesthesia/sedation with a single shot, peripheral nerve block versus general anesthesia/sedation with a continuous, peripheral nerve block.

All anesthesia will be provided by an attending anesthesiologist with or without an anesthesiology resident/CRNA. Patients will have standard ASA monitors placed (pulse oximeter, blood pressure, EKG) and an intravenous line started. Sedation will be given using a combination of midazolam (1-4 mg) and fentanyl (25-100 mcg). Patients in both groups will receive an ultrasound-guided peripheral nerve block. The block will be either an infraclavicular brachial plexus block or a popliteal nerve block, depending on the location of the fracture. The appropriate region will be prepped with a chlorohexidine solution on the appropriate surgical side and the appropriate site will be visualized under ultrasound. For the group receiving a single shot block, a 22 gauge, 3.5 inch needle will be used and 20cc of 2% lidocaine with 1:200,000 epinephrine + 20 cc of 0.5% bupivacaine with 1:300,000 epinephrine will be injected around the nerve after confirming negative aspiration every 5 cc. For those receiving a continuous infusion, a 17 gauge Tuohy needle will be used and 20cc of 2% lidocaine with epinephrine + 20 cc of 0.5% bupivacaine with 1:300,000 epinephrine will be injected around the nerve after confirming negative aspiration every 5cc. Once the injection is complete, an indwelling catheter will be placed with its tip location confirmed and then secured at the skin.

After placement of the regional block, general anesthesia/sedation will be administered and maintained at the discretion of the anesthesiologist. Induction of anesthesia will involve IV propofol (2mg/kg) and fentanyl (1-2mcg/kg). Neuromuscular blockade will be used at the discretion of the anesthesiologist and will be reversed appropriately. Anesthetic maintenance will involve inhalational agents, IV agents, air, and oxygen. Fentanyl will be the only intraoperative analgesic used and will be dosed as determined by the anesthesiologist.

After completion of the surgery, patients will be taken to the PACU where those with continuous catheters will have an OnQ pump attached to it. The patient will begin receiving a continuous infusion of 0.2% ropivacaine through the catheter at a rate of 8 cc/hr. The patient will be discharged home with the catheter for 48 hours. The study participant will self-discontinue the catheter in 2 days. This involves removing the tegaderm dressing and gently pulling the catheter out from under the skin. A bandage may then be applied. Germaine Cuff, the investigators anesthesiology RN, will be available via phone to answer any questions study participants may have regarding discontinuation of the catheter. Breakthrough pain while in the PACU will be treated with IV fentanyl and PO Percocet as needed.

Postoperatively, all patients will be discharged home with a prescription for Percocet 5/325 with instructions to take 1-2 tabs every 4-6hrs as needed for pain.

Data collection Location and type of surgical procedure, duration of procedure, and duration of intravenous sedation will also be recorded. Total time in the operating room will also be noted. Time admitted to PACU, time clinically ready for discharge, time actually discharge, PACU medications for nausea/vomiting and PACU meds for pain will all be recorded prior to discharge.

Post-operative pain will be assessed using the Visual Analogue Scale (0-100) prior to being discharged from PACU. Time to discharge and amount of pain medication taken in the PACU will be recorded.

Patients will be contacted 8 hours, 12 hours, 24 hours, 48 hours and 72hrs after surgery by the operative surgeon or research coordinator to assess their pain scale and pain medication intake. Patients will be seen for routine post-operative follow-up visits at two, six, twelve, twenty-four, and fifty-two weeks. At these times, patients will be assessed for pain, residual neurological symptoms, and signs of infection. Patients will also be asked if they were satisfied with their postoperative pain control. Total duration of study will be fifty-two weeks. Data collection documents will be distributed to the patients at time of surgery to assist in patient understanding.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Ankle SSB intervention 2: Ankle OnQ intervention 3: DR SSB intervention 4: DR OnQ
Intervention descriptions: intervention 1: general anesthesia/sedation with a single shot; Primary predictor variable: single shot block, a 22 gauge, 3.5 inch needle will be used and 20cc of 2% lidocaine with 1:200,000 epinephrine + 20cc of 0.5% bupivacaine with 1:300,000 epinephrine will be injected around the nerve after confirming negative aspiration every 5 cc. intervention 2: versus regional block with continuous infusion using an OnQ pump. 17 gauge Tuohy needle will be used and 20cc of 2% lidocaine with epinephrine +20cc of 0.5% bupivacaine with1:300,000epinephrine will be injected around the nerve after confirming negative aspiration every 5cc. intervention 3: general anesthesia/sedationwith a single shot; general anesthesia/sedation with a single shot; Primary predictor variable: single shot block, a 22 gauge, 3.5 inch needle will be used and 20cc of 2% lidocaine with 1:200,000 epinephrine + 20cc of 0.5% bupivacaine with 1:300,000 epinephrine will be injected around the nerve after confirming negative aspiration every 5 cc. intervention 4: versus regional block with continuous infusion using an OnQ pump. 17 gauge Tuohy needle will be used and 20cc of 2% lidocaine with epinephrine +20cc of 0.5% bupivacaine with1:300,000epinephrine will be injected around the nerve after confirming negative aspiration every 5cc.

Protocol documents:
Prot_SAP_000.pdf: 
IRB #S12-03598 
	  
Version:	  12-­‐18-­‐12	  
Comparison	  between	  single	  shot	  peripheral	  nerve	  block	  and	  continuous	  infusion	  via	  a	  On-­‐Q	  
Pump:	  a	  randomized	  prospective	  control	  trial	  
	  
	  
	  
	  
Principal	  Investigator:	  	  Nirmal	  Tejwani,	  MD	  
	  
	  
Co-­‐investigators:	  
David	  Ding,	  MD	  
Sudheer	  Jain,	  M.D.	  
David	  Taormina,	  BS	  
	  
	  
	  
	  
	  
Department	  of	  Orthopaedic	  Surgery	  
NYU-­‐Hospital	  for	  Joint	  Diseases	  
301	  East	  17th	  Street	  
New	  York,	  NY	  10003	  
	  
	  
	  


IRB #S12-03598 
	  
Version:	  12-­‐18-­‐12	  
Brief	  Summary	  
Peripheral	  nerve	  blocks	  have	  been	  well	  studied	  in	  the	  literature	  with	  generally	  good	  results	  for	  
controlling	  post	  operative	  pain	  following	  orthopaedic	  surgery.	  	  Regional	  anesthesia	  has	  many	  benefits.	  	  
It	  provides	  excellent	  intraoperative	  anesthesia	  and	  muscle	  relaxation	  as	  well	  as	  analgesia	  that	  continues	  
into	  the	  post-­‐operative	  period.	  	  These	  regional	  blocks	  are	  also	  effective	  in	  controlling	  pain	  in	  the	  
immediate	  post-­‐operative	  period.	  However,	  as	  the	  block	  wears	  off,	  patients	  begin	  experiencing	  
increased	  pain.	  Compared	  to	  patients	  treated	  without	  regional	  blocks,	  these	  patients	  will	  often	  
experience	  a	  "rebound	  pain"-­‐-­‐pain	  occurring	  12-­‐24	  hours	  after	  surgery	  that	  is	  subjectively	  worse	  than	  
that	  in	  patients	  treated	  without	  regional	  blocks.	  Therefore,	  we	  propose	  to	  use	  a	  continuous	  infusion	  of	  
anesthetic	  in	  order	  to	  provide	  sustained	  pain	  control	  post-­‐operatively.	  Preoperatively,	  patients	  will	  be	  
randomized	  into	  a	  single	  shot	  peripheral	  nerve	  block	  versus	  a	  continuous	  infusion	  of	  peripheral	  nerve	  
block.	  	  	  Post-­‐operatively,	  pain	  will	  be	  assessed	  using	  the	  Visual	  Analogue	  Scale	  (1-­‐100)	  prior	  to	  being	  
discharged	  from	  PACU.	  Time	  to	  discharge	  and	  amount	  of	  pain	  medication	  taken	  will	  be	  recorded.	  
Patients	  will	  be	  contacted	  at	  certain	  time	  intervals	  postoperatively	  to	  assess	  their	  pain	  scale	  and	  pain	  
medication	  intake.	  Patients	  will	  be	  seen	  for	  routine	  post-­‐operative	  follow-­‐up	  visits	  where	  they	  will	  be	  
assessed	  for	  satisfaction,	  pain,	  residual	  neurological	  symptoms,	  and	  signs	  of	  infection.	  	  	  
Purpose	  
The	  purpose	  of	  this	  randomized	  prospective	  study	  will	  be	  to	  compare	  post-­‐operative	  pain	  control	  after	  
extremity	  fracture	  fixation	  surgery	  between	  patients	  who	  receive	  single	  shot	  versus	  continuous	  
peripheral	  nerve	  blocks.	  	  
Scientific	  or	  Scholarly	  Rationale	  
Peripheral	  nerve	  blocks	  have	  been	  well	  studied	  in	  the	  literature	  with	  generally	  good	  results	  for	  
controlling	  post	  operative	  pain	  following	  orthopaedic	  surgery	  1-­‐4.  Regional	  anesthesia	  has	  many	  
benefits.	  	  It	  provides	  excellent	  intraoperative	  anesthesia	  and	  muscle	  relaxation	  as	  well	  as	  analgesia	  that	  
continues	  into	  the	  post-­‐operative	  period.	  	  Airway	  manipulations	  are	  avoided,	  post-­‐operative	  nausea	  and	  
vomiting	  are	  diminished,	  post-­‐anesthesia	  care	  unit	  stay	  are	  shortened,	  and	  fewer	  nursing	  interventions	  
in	  the	  post-­‐anesthesia	  care	  unit	  are	  required5-­‐6.	  	  
Patients	  who	  have	  operative	  fixation	  of	  extremity	  fractures	  (ankle,	  wrist,	  forearm)	  are	  typically	  
ambulatory	  patients.	  	  However,	  many	  become	  hospitalized	  overnight	  secondary	  to	  inadequate	  pain	  
control,	  increasing	  hospital	  costs.	  	  Goldstein	  et	  al.	  showed	  that	  patients who underwent popliteal blocks 
after ankle fracture fixation demonstrated significantly better pain control immediately postoperatively7. 
The	  need	  for	  overnight	  hospitalization	  secondary	  to	  pain	  is	  decreased,	  as	  are	  nonsurgical	  operating	  
room	  times.	  	   
Despite	  the	  success	  of	  regional	  anesthesia,	  a	  phenomenon	  known	  as	  “rebound	  pain”	  has	  been	  shown	  to	  
occur	  as	  the	  original	  block	  wears	  off7-­‐9.	  	  Patients	  with	  blocks	  will	  experience	  significantly	  increased	  pain	  
compared	  to	  those	  without	  blocks	  approximately	  12-­‐24	  hours	  after	  surgery.	  This	  can	  be	  controlled	  with	  
early	  narcotic	  administration	  but	  can	  be	  a	  source	  of	  significant	  discomfort	  to	  a	  patient	  if	  not	  recognized	  


IRB #S12-03598 
	  
Version:	  12-­‐18-­‐12	  
and	  treated	  in	  time.	  	  	  A	  few	  studies	  have	  shown	  that	  continuous	  infusions	  of	  various	  numbing	  agents	  are	  
efficacious	  in	  prolonged	  pain	  control,	  even	  in	  the	  ambulatory	  setting10-­‐12.	  	  	  Nevertheless,	  no	  studies	  have	  
thus	  performed	  a	  randomized	  prospective	  control	  trial	  studying	  the	  efficacy	  of	  continuous	  infusion	  
therapy	  on	  pain	  control	  following	  extremity	  fracture	  surgery.	  	  
Aims	  
1. To	  determine	  the	  effectiveness	  of	  continuously	  infused	  regional	  anesthetic	  for	  pain	  control	  in	  
extremity	  fracture	  surgery	  
2. To	  determine	  the	  effect	  of	  rebound	  pain	  on	  patient	  satisfaction	  of	  surgery	  
Description	  of	  study	  and	  study	  procedure	  
Consent	  
All	  patients	  being	  treated	  with	  open	  reduction	  internal	  fixation	  for	  foot,	  ankle,	  tibia,	  elbow,	  forearm	  and	  
wrist	  fractures	  at	  New	  York	  University	  Medical	  Center,	  NYU-­‐Hospital	  for	  Joint	  Diseases	  will	  be	  asked	  to	  
participate	  in	  this	  study.	  	  At	  the	  patients	  preoperative	  office	  visit,	  they	  will	  be	  asked	  to	  participate	  in	  the	  
study	  and	  provided	  a	  copy	  of	  the	  consent	  form	  at	  that	  time	  which	  they	  can	  take	  home	  with	  them.	  All	  
questions	  will	  be	  answered	  and	  they	  will	  be	  asked	  verbally	  if	  they	  will	  consent	  to	  being	  a	  part	  of	  the	  
study.	  Patients	  will	  then	  have	  the	  opportunity	  to	  either	  sign	  the	  written	  consent	  forms	  or	  wait	  till	  the	  
surgical	  date	  to	  think	  about	  the	  study	  and	  any	  additional	  questions	  they	  may	  have.	  At	  the	  time	  of	  
surgery,	  patients	  will	  be	  consented	  for	  surgery.	  	  If	  the	  patient	  did	  not	  give	  written	  consent	  at	  the	  
preoperative	  visit,	  they	  will	  be	  asked	  if	  they	  have	  any	  questions	  about	  the	  study.	  All	  questions	  will	  again	  
be	  answered.	  They	  will	  then	  be	  asked	  verbally	  if	  they	  are	  willing	  to	  participate	  in	  the	  study,	  if	  they	  
respond	  yes,	  then	  written	  consent	  will	  be	  obtained	  at	  that	  time.	  
Randomization	  
	  Patients	  will	  then	  be	  randomized	  (using	  an	  online	  randomizer,	  similar	  to	  a	  flip	  of	  a	  coin)	  to	  one	  of	  two	  
anesthetic	  protocols:	  regional	  block	  with	  single	  dose	  of	  anesthetic	  versus	  regional	  block	  with	  continuous	  
infusion	  using	  an	  OnQ	  pump.	  If	  for	  some	  reason,	  the	  anesthesiologist	  feels	  that	  a	  patient	  would	  benefit	  
from	  one	  type	  of	  anesthesia	  	  over	  another,	  the	  patient	  will	  be	  removed	  from	  the	  study	  and	  given	  that	  
type	  of	  anesthesia.	  
Intervention	  
Patients	  will	  be	  randomized	  to	  one	  of	  two	  anesthetic	  protocols:	  	  general	  anesthesia/sedation	  with	  a	  
single	  shot,	  peripheral	  nerve	  block	  versus	  general	  anesthesia/sedation	  with	  a	  continuous,	  peripheral	  
nerve	  block.	  
	  
All	  anesthesia	  will	  be	  provided	  by	  an	  attending	  anesthesiologist	  with	  or	  without	  an	  anesthesiology	  
resident/CRNA.	  	  Patients	  will	  have	  standard	  ASA	  monitors	  placed	  (pulse	  oximeter,	  blood	  pressure,	  EKG)	  
and	  an	  intravenous	  line	  started.	  	  Sedation	  will	  be	  given	  using	  a	  combination	  of	  midazolam	  (1-­‐4	  mg)	  and	  
fentanyl	  (25-­‐100	  mcg).	  	  Patients	  in	  both	  groups	  will	  receive	  an	  ultrasound-­‐guided	  peripheral	  nerve	  block.	  	  
The	  block	  will	  be	  either	  an	  infraclavicular	  brachial	  plexus	  block	  or	  a	  popliteal	  nerve	  block,	  depending	  on	  


IRB #S12-03598 
	  
Version:	  12-­‐18-­‐12	  
the	  location	  of	  the	  fracture.	  	  The	  appropriate	  region	  will	  be	  prepped	  with	  a	  chlorohexidine	  solution	  on	  
the	  appropriate	  surgical	  side	  and	  the	  appropriate	  site	  will	  be	  visualized	  under	  ultrasound.	  	  For	  the	  group	  
receiving	  a	  single	  shot	  block,	  a	  22	  gauge,	  3.5	  inch	  needle	  will	  be	  used	  and	  20cc	  of	  2%	  lidocaine	  with	  
1:200,000	  epinephrine	  +	  20	  cc	  of	  0.5%	  bupivacaine	  with	  1:300,000	  epinephrine	  will	  be	  injected	  around	  
the	  nerve	  after	  confirming	  negative	  aspiration	  every	  5	  cc.	  	  For	  those	  receiving	  a	  continuous	  infusion,	  a	  
17	  gauge	  Tuohy	  needle	  will	  be	  used	  and	  20cc	  of	  2%	  lidocaine	  with	  epinephrine	  +	  20	  cc	  of	  0.5%	  
bupivacaine	  with	  1:300,000	  epinephrine	  will	  be	  injected	  around	  the	  nerve	  after	  confirming	  negative	  
aspiration	  every	  5cc.	  	  Once	  the	  injection	  is	  complete,	  an	  indwelling	  catheter	  will	  be	  placed	  with	  its	  tip	  
location	  confirmed	  and	  then	  secured	  at	  the	  skin.	  
	  
After	  placement	  of	  the	  regional	  block,	  general	  anesthesia/sedation	  will	  be	  administered	  and	  maintained	  
at	  the	  discretion	  of	  the	  anesthesiologist.	  	  Induction	  of	  anesthesia	  will	  involve	  IV	  propofol	  (2mg/kg)	  and	  
fentanyl	  (1-­‐2mcg/kg).	  	  Neuromuscular	  blockade	  will	  be	  used	  at	  the	  discretion	  of	  the	  anesthesiologist	  and	  
will	  be	  reversed	  appropriately.	  	  Anesthetic	  maintenance	  will	  involve	  inhalational	  agents,	  IV	  agents,	  air,	  
and	  oxygen.	  	  Fentanyl	  will	  be	  the	  only	  intraoperative	  analgesic	  used	  and	  will	  be	  dosed	  as	  determined	  by	  
the	  anesthesiologist.	  
	  
After	  completion	  of	  the	  surgery,	  patients	  will	  be	  taken	  to	  the	  PACU	  where	  those	  with	  continuous	  
catheters	  will	  have	  an	  OnQ	  pump	  attached	  to	  it.	  	  The	  patient	  will	  begin	  receiving	  a	  continuous	  infusion	  
of	  0.2%	  ropivacaine	  through	  the	  catheter	  at	  a	  rate	  of	  8	  cc/hr.	  	  The	  patient	  will	  be	  discharged	  home	  with	  
the	  catheter	  for	  48	  hours.	  	  The	  study	  participant	  will	  self-­‐discontinue	  the	  catheter	  in	  2	  days.	  	  This	  
involves	  removing	  the	  tegaderm	  dressing	  and	  gently	  pulling	  the	  catheter	  out	  from	  under	  the	  skin.	  	  A	  
bandage	  may	  then	  be	  applied.	  	  Germaine	  Cuff,	  our	  anesthesiology	  RN,	  will	  be	  available	  via	  phone	  to	  
answer	  any	  questions	  study	  participants	  may	  have	  regarding	  discontinuation	  of	  the	  catheter.	  	  
Breakthrough	  pain	  while	  in	  the	  PACU	  will	  be	  treated	  with	  IV	  fentanyl	  and	  PO	  Percocet	  as	  needed.	  
	  
Postoperatively,	  all	  patients	  will	  be	  discharged	  home	  with	  a	  prescription	  for	  Percocet	  5/325	  with	  
instructions	  to	  take	  1-­‐2	  tabs	  every	  4-­‐6hrs	  as	  needed	  for	  pain.	  
Data	  collection	  
Location	  and	  type	  of	  surgical	  procedure,	  duration	  of	  procedure,	  and	  duration	  of	  intravenous	  sedation	  
will	  also	  be	  recorded.	  	  Total	  time	  in	  the	  operating	  room	  will	  also	  be	  noted.	  Time	  admitted	  to	  PACU,	  time	  
clinically	  ready	  for	  discharge,	  time	  actually	  discharge,	  PACU	  medications	  for	  nausea/vomiting	  and	  PACU	  
meds	  for	  pain	  will	  all	  be	  recorded	  prior	  to	  discharge.	  
Post-­‐operative	  pain	  will	  be	  assessed	  using	  the	  Visual	  Analogue	  Scale	  (0-­‐100)	  prior	  to	  being	  discharged	  
from	  PACU.	  Time	  to	  discharge	  and	  amount	  of	  pain	  medication	  taken	  in	  the	  PACU	  will	  be	  recorded.	  
Patients	  	  will	  be	  contacted	  8	  hours,	  12	  hours,	  24	  hours,	  48	  hours	  and	  72hrs	  after	  surgery	  by	  the	  
operative	  surgeon	  or	  research	  coordinator	  to	  assess	  their	  pain	  scale	  and	  pain	  medication	  intake.	  
Patients	  will	  be	  seen	  for	  routine	  post-­‐operative	  follow-­‐up	  visits	  at	  two,	  six,	  twelve,	  twenty-­‐four,	  and	  
fifty-­‐two	  weeks.	  At	  these	  times,	  patients	  will	  be	  assessed	  for	  pain,	  residual	  neurological	  symptoms,	  and	  
signs	  of	  infection.	  	  Patients	  will	  also	  be	  asked	  if	  they	  were	  satisfied	  with	  their	  postoperative	  pain	  control.	  
Total	  duration	  of	  study	  will	  be	  fifty-­‐two	  weeks.	  	  Data	  collection	  documents	  will	  be	  distributed	  to	  the	  
patients	  at	  time	  of	  surgery	  to	  assist	  in	  patient	  understanding.	  	  


IRB #S12-03598 
	  
Version:	  12-­‐18-­‐12	  
Inclusion	  criteria	  
1. Patients	  at	  least	  18	  years	  old.	  
2. Male	  or	  Female	  	  
3. All	  racial	  and	  ethnic	  groups	  
4. Fractures	  and	  fracture/dislocations	  of	  the	  foot,	  ankle,	  tibia,	  fibula,	  elbow,	  forearm,	  wrist	  and	  
hand	  
5. Patients	  who	  opt	  for	  surgical	  treatment	  of	  their	  fractures.	  
6. Patients	  who	  consent	  to	  be	  randomized.	  
7. Patients	  who	  are	  willing	  to	  follow-­‐up	  for	  a	  minimum	  of	  52	  weeks.	  
Exclusion	  criteria	  
1. Patients	  younger	  than	  18	  years	  old.	  
2. Patients	  who	  are	  on	  chronic	  opioids	  
3. Patients	  who	  abuse	  opioids	  
4. Patients	  who	  are	  unwilling	  to	  follow-­‐up	  for	  a	  minimum	  of	  52	  weeks.	  
5. Neurologic	  condition	  that	  could	  interfere	  with	  pain	  sensation	  
	  
Characteristics	  of	  the	  Research	  Population	  
1. Total	  number	  of	  subjects:	  100	  subjects	  
2. Gender:	  Male	  or	  Female	  
3. Racial	  and	  Ethnic	  Origins:	  All	  are	  included	  
	  
Study	  payments/cost:	  	  
Study	  participants	  will	  not	  incur	  any	  additional	  costs	  or	  payments	  as	  a	  result	  of	  this	  study.	  	  Any	  
additional	  costs	  will	  be	  absorbed	  by	  the	  NYU	  Departments	  of	  Orthopaedics	  and	  Anesthesia	  
Potential	  Risks	  and	  Discomforts:	  	  	  
The	  research-­‐related	  complications	  associated	  with	  regional	  block	  include,	  but	  are	  not	  limited	  to,	  
intravascular	  injection,	  local	  anesthetic	  toxicity,	  hematoma	  formation	  around	  insertion	  site,	  infection	  
around	  injection	  site,	  permanent	  or	  temporary	  nerve	  injury,	  and	  allergic	  reactions	  to	  the	  medication	  
injected.	  
The	  research-­‐related	  complications	  associated	  with	  the	  On-­‐Q	  pump	  include,	  but	  are	  not	  limited	  to,	  site	  
infection,	  superficial	  nerve	  injury,	  and	  local	  anesthetic	  toxicity.	  	  There	  may	  be	  additional	  risk	  of	  injury	  in	  
the	  On-­‐Q	  pump	  Group,	  if	  participants	  resume	  regular	  activities,	  prematurely,	  while	  free	  of	  pain.	  
There	  may	  be	  unknown	  risks/discomforts	  involved.	  	  Study	  staff	  will	  update	  all	  patients	  in	  a	  timely	  way	  
on	  any	  new	  information	  that	  may	  affect	  the	  patients’	  health,	  welfare,	  or	  decision	  to	  remain	  in	  the	  study.	  	  
If	  the	  patients	  have	  any	  questions	  or	  sustain	  any	  injury	  during	  the	  course	  of	  the	  research	  or	  experience	  
any	  adverse	  reaction	  to	  one	  of	  the	  surgical	  treatments	  they	  will	  be	  informed	  during	  the	  process	  of	  
obtaining	  informed	  consent	  that	  they	  should	  contact	  the	  Principal	  Investigator	  Dr.	  Nirmal	  Tejwani	  at	  the	  
following	  telephone	  number	  212-­‐598-­‐6599.	  


IRB #S12-03598 
	  
Version:	  12-­‐18-­‐12	  
In	  addition,	  if	  there	  is	  any	  Adverse	  Event	  that	  occurs	  during	  the	  study,	  then	  the	  Principal	  Investigator	  will	  
make	  the	  IRB	  aware	  of	  this.	  	  The	  Principal	  Investigator	  will	  submit	  a	  Reportable	  Events	  Form	  for	  all	  
reportable	  information	  to	  the	  IRB	  within	  5	  working	  days	  from	  when	  the	  Principal	  Investigator	  learns	  of	  
the	  event	  or	  new	  information.	  
Potential	  Benefits:	  	  The	  patients	  are	  not	  likely	  to	  receive	  any	  direct	  benefit	  from	  their	  participation	  in	  
this	  study	  aside	  from	  possible	  increased	  pain	  relief	  after	  operative	  fixation	  of	  their	  fracture.	  	  However,	  
the	  patients’	  participation	  may	  help	  the	  investigators	  better	  understand	  the	  best	  post-­‐operative	  pain	  
protocol	  for	  extremity	  fracture	  fixation.	  	  In	  addition,	  the	  patients’	  participation	  may	  help	  the	  
investigators	  better	  understand	  if	  there	  is	  any	  prolonged	  benefit	  to	  with	  one	  post-­‐operative	  treatment	  
over	  the	  other,	  which	  could	  thereby	  give	  orthopaedic	  surgeons	  conclusive	  evidence	  of	  the	  best	  post-­‐
operative	  pain	  protocol	  for	  operative	  fractures	  about	  the	  forearm	  and	  wrist	  that	  could	  also	  translate	  
into	  better	  patient	  satisfaction.	  	  	  
Data	  Monitoring	  Plan:	  	  
1. Types	  of	  data	  or	  events:	  	  
a. Intravascular	  injection	  	  
b. local	  anesthetic	  toxicity	  	  
c. hematoma	  formation	  	  
d. Infection	  
e. Neurologic	  injury	  
f. 
Allergic	  reaction	  
2. Responsibilities	  and	  roles	  for	  gathering,	  evaluating	  and	  monitoring	  the	  data:	  
a. All	  data	  (including	  details	  about	  adverse/unexpected	  events)	  will	  be	  collected	  by	  the	  
operative	  team	  or	  research	  coordinator	  at	  specific	  time	  points:	  8hrs	  post-­‐op,	  24hr,	  48hr,	  
72hrs,	  2wks,	  6wks,	  12wks,	  24wks	  and	  52wks	  and	  reported	  to	  the	  research	  coordinator	  
using	  standard	  templated	  data	  collection	  forms.	  All	  patients	  will	  be	  told	  to	  call	  Dr.	  
Nirmal	  Tejwani	  at	  212-­‐598-­‐6599	  to	  report	  adverse	  reactions	  during	  the	  study.	  	  
b. All	  data	  will	  be	  verified	  by	  the	  research	  team	  and	  coordinator	  for	  accuracy	  and	  
compliance	  with	  the	  protocol	  at	  each	  time	  point	  as	  designated	  above.	  
3. Information	  about	  the	  monitoring	  entity:	  
a. Principle	  investigator	  Dr.	  Nirmal	  Tejwani,	  Dr.	  Sudheer	  Jain,	  and	  Dr.	  David	  Ding	  comprise	  
the	  monitoring	  entity.	  	  
4. Reporting	  Adverse	  events	  and	  Unanticipated	  problems	  to	  the	  monitoring	  entity:	  
a. The	  Principal	  Investigator	  will	  submit	  a	  Reportable	  Events	  Form	  for	  all	  reportable	  
information	  to	  the	  IRB	  within	  5	  working	  days	  from	  when	  the	  Principal	  Investigator	  learns	  
of	  the	  event	  or	  new	  information.	  
5. Assessments:	  
a. The	  Monitoring	  entity	  will	  review	  data	  monthly	  and	  assess	  the	  data	  for	  unanticipated	  
problems	  involving	  risks	  to	  participants.	  
6. Criteria	  for	  Action:	  
a. Specific	  triggers	  for	  action	  include	  any	  event	  that	  is	  deemed	  to	  be	  a	  risk	  to	  life	  or	  limb.	  	  
7. Procedure	  for	  communicating:	  	  
a. The	  Principal	  Investigator	  will	  submit	  a	  Reportable	  Events	  Form	  for	  all	  reportable	  
information	  to	  the	  IRB	  within	  5	  working	  days	  from	  when	  the	  Principal	  Investigator	  learns	  
of	  the	  event	  or	  new	  information.	  


IRB #S12-03598 
	  
Version:	  12-­‐18-­‐12	  
	  
Data	  Storage	  and	  Confidentiality:	  All	  patients	  will	  be	  de-­‐identified	  and	  given	  a	  code.	  Information	  linking	  
the	  linkage	  codes	  to	  the	  participants’	  names,	  social	  security	  numbers	  and	  medical	  record	  numbers	  will	  
be	  stored	  in	  a	  secure	  location	  separate	  from	  the	  medical	  information.	  	  Access	  to	  the	  information	  linking	  
the	  linkage	  codes	  with	  participant	  identifiers	  shall	  be	  documented.	  	  The	  patient’s	  informed	  consent	  will	  
be	  obtained	  in	  one	  of	  the	  exam	  rooms	  in	  the	  private	  office.	  
Participant	  medical	  information	  will	  be	  stored	  electronically	  within	  a	  password	  protected	  spreadsheet	  
available	  only	  to	  the	  PI,	  co-­‐investigators,	  and	  research	  staff	  as	  necessary	  for	  data	  analysis.	  	  The	  names,	  
social	  security	  numbers,	  and	  medical	  record	  numbers	  of	  the	  study	  participants	  will	  be	  deleted	  from	  their	  
stored	  medical	  information	  and	  replaced	  with	  a	  linkage	  code.	  	  Access	  to	  participant	  medical	  information	  
contained	  within	  the	  registry	  will	  be	  restricted.	  
Protection	  Against	  Risk:	  All	  procedures	  will	  be	  performed	  as	  outlined	  above.	  After	  the	  procedure	  pt	  will	  
be	  contacted	  6-­‐8	  hours	  after	  surgery	  and	  at	  24	  hours,	  48	  hours	  and	  72hours	  after	  surgery	  by	  the	  
operative	  surgeon	  or	  research	  coordinator	  to	  assess	  their	  pain	  scale	  and	  pain	  medication	  intake.	  
Patients	  will	  be	  seen	  for	  routine	  post-­‐operative	  follow-­‐up	  visits	  at	  two,	  six,	  twelve,	  twenty-­‐four,	  and	  
fifty-­‐two	  weeks.	  At	  these	  times,	  patients	  will	  be	  assessed	  for	  pain,	  residual	  neurological	  symptoms,	  and	  
signs	  of	  infection,	  and	  starting	  at	  the	  six	  week	  time	  point,	  patient's	  functional	  status	  will	  be	  assessed	  
using	  the	  Disability	  of	  the	  Arm,	  Shoulder	  and	  Hand	  (DASH)	  and	  SMFA	  scores,	  both	  are	  widely	  accepted	  
and	  validated	  functional	  measures.	  
Method	  of	  Subject	  Identification	  and	  Recruitment:	  All	  patients	  seen	  in	  the	  outpatient	  office,	  who	  fit	  the	  
inclusion	  criteria	  will	  be	  asked	  to	  participate	  in	  the	  study.	  	  
Subject/Representative	  Comprehension:	  None	  
Debriefing	  Procedures:	  All	  patients	  will	  have	  regular	  follow-­‐up	  at	  which	  point,	  all	  questions	  regarding	  
the	  study	  can	  be	  answered.	  	  
Documentation	  of	  Consent:	  A	  copy	  of	  the	  signed	  consent	  form	  will	  be	  securely	  kept	  for	  our	  records.	  
Statistical	  analysis	  plan:	  	  
A	  preoperative	  power	  analysis	  was	  performed.	  	  On	  a	  VAS	  scaled	  from	  1-­‐100,	  assuming	  a	  standard	  
deviation	  of	  20,	  the	  number	  needed	  to	  detect	  a	  10	  point	  changed	  in	  VAS	  was	  38.	  Assuming	  a	  drop	  out	  
rate	  of	  20%,	  we	  will	  require	  50	  patients	  in	  each	  group	  to	  determine	  significance.	  	  	  The	  primary	  end	  
points	  of	  the	  study	  for	  Visual	  Analog	  Score	  will	  be	  assess	  using	  two-­‐group	  t-­‐tests	  (Mann-­‐Whitney	  U	  test	  
where	  appropriate).	  	  Amount	  of	  pain	  medication	  utilized	  post	  operatively	  will	  be	  assessed	  using	  Student	  
t-­‐tests.	  	  Residual	  neurological	  symptoms	  and	  signs	  of	  infection	  will	  be	  reported	  as	  descriptive	  statistics.	  	  
Descriptive	  statistics	  will	  be	  reported	  as	  means	  +/-­‐	  SD	  for	  continuous	  variables	  and	  as	  frequencies	  and	  
percentages	  for	  categorical	  variables.	  
	  
	  


IRB #S12-03598 
	  
Version:	  12-­‐18-­‐12	  
	  
References	  
1.	  
Rukewe	  A,	  Adeoye,	  II,	  Sule	  UM,	  Fatiregun	  A.	  Interscalene	  block	  for	  shoulder	  surgery.	  Ann	  Afr	  
Med.	  Apr-­‐Jun	  2011;10(2):185-­‐187.	  
2.	  
Hunt	  KJ,	  Higgins	  TF,	  Carlston	  CV,	  Swenson	  JR,	  McEachern	  JE,	  Beals	  TC.	  Continuous	  peripheral	  
nerve	  blockade	  as	  postoperative	  analgesia	  for	  open	  treatment	  of	  calcaneal	  fractures.	  J	  Orthop	  
Trauma.	  Mar	  2010;24(3):148-­‐155.	  
3.	  
de	  Visme	  V,	  Picart	  F,	  Le	  Jouan	  R,	  Legrand	  A,	  Savry	  C,	  Morin	  V.	  Combined	  lumbar	  and	  sacral	  
plexus	  block	  compared	  with	  plain	  bupivacaine	  spinal	  anesthesia	  for	  hip	  fractures	  in	  the	  elderly.	  
Reg	  Anesth	  Pain	  Med.	  Mar-­‐Apr	  2000;25(2):158-­‐162.	  
4.	  
de	  Visme	  V.	  Peripheral	  blocks	  of	  the	  lower	  limb	  for	  repair	  of	  fractured	  neck	  of	  femur.	  Br	  J	  
Anaesth.	  Sep	  1998;81(3):483-­‐484.	  
5.	  
Oh	  JH,	  Kim	  WS,	  Kim	  JY,	  Gong	  HS,	  Rhee	  KY.	  Continuous	  intralesional	  infusion	  combined	  with	  
interscalene	  block	  was	  effective	  for	  postoperative	  analgesia	  after	  arthroscopic	  shoulder	  surgery.	  
J	  Shoulder	  Elbow	  Surg.	  May-­‐Jun	  2007;16(3):295-­‐299.	  
6.	  
Egol	  KA,	  Soojian	  MG,	  Walsh	  M,	  Katz	  J,	  Rosenberg	  AD,	  Paksima	  N.	  Regional	  anesthesia	  improves	  
outcome	  after	  distal	  radius	  fracture	  fixation	  over	  general	  anesthesia.	  J	  Orthop	  Trauma.	  Sep	  
2012;26(9):545-­‐549.	  
7.	  
Goldstein	  RY,	  Montero	  N,	  Jain	  S,	  Egol	  KA,	  Tejwani	  NC.	  Efficacy	  of	  popliteal	  block	  in	  post-­‐
operative	  pain	  control	  after	  ankle	  fracture	  fixation:	  A	  prospective	  randomized	  study.	  J	  Orthop	  
Trauma.	  Jun	  22	  2012.	  
8.	  
Williams	  BA,	  Bottegal	  MT,	  Kentor	  ML,	  Irrgang	  JJ,	  Williams	  JP.	  Rebound	  pain	  scores	  as	  a	  function	  
of	  femoral	  nerve	  block	  duration	  after	  anterior	  cruciate	  ligament	  reconstruction:	  retrospective	  
analysis	  of	  a	  prospective,	  randomized	  clinical	  trial.	  Reg	  Anesth	  Pain	  Med.	  May-­‐Jun	  
2007;32(3):186-­‐192.	  
9.	  
DeMarco	  JR,	  Componovo	  R,	  Barfield	  WR,	  Liles	  L,	  Nietert	  P.	  Efficacy	  of	  augmenting	  a	  subacromial	  
continuous-­‐infusion	  pump	  with	  a	  preoperative	  interscalene	  block	  in	  outpatient	  arthroscopic	  
shoulder	  surgery:	  a	  prospective,	  randomized,	  blinded,	  and	  placebo-­‐controlled	  study.	  
Arthroscopy.	  May	  2011;27(5):603-­‐610.	  
10.	  
Fredrickson	  MJ,	  Ball	  CM,	  Dalgleish	  AJ.	  Analgesic	  effectiveness	  of	  a	  continuous	  versus	  single-­‐
injection	  interscalene	  block	  for	  minor	  arthroscopic	  shoulder	  surgery.	  Reg	  Anesth	  Pain	  Med.	  Jan-­‐
Feb	  2010;35(1):28-­‐33.	  
11.	  
Kean	  J,	  Wigderowitz	  CA,	  Coventry	  DM.	  Continuous	  interscalene	  infusion	  and	  single	  injection	  
using	  levobupivacaine	  for	  analgesia	  after	  surgery	  of	  the	  shoulder.	  A	  double-­‐blind,	  randomised	  
controlled	  trial.	  J	  Bone	  Joint	  Surg	  Br.	  Sep	  2006;88(9):1173-­‐1177.	  
12.	  
Ilfeld	  BM,	  Morey	  TE,	  Wright	  TW,	  Chidgey	  LK,	  Enneking	  FK.	  Continuous	  interscalene	  brachial	  
plexus	  block	  for	  postoperative	  pain	  control	  at	  home:	  a	  randomized,	  double-­‐blinded,	  placebo-­‐
controlled	  study.	  Anesth	  Analg.	  Apr	  2003;96(4):1089-­‐1095,	  table	  of	  contents.