A Pain Study Comparing Two Commonly Used Medications to Treat Pain After Bowel Surgery
A Pain Study Comparing Two Commonly Used Medications to Treat Pain After Bowel Surgery
This research study is testing whether the local anesthetic lidocaine is as effective as
 ropivacaine for post-operative pain control in continuous thoracic paravertebral nerve
 blocks. Ropivacaine and Lidocaine are FDA-approved drugs that has been successfully used in
 this hospital for post-operative pain control for the past few years, thus has become the
 standard drugs used for this nerve block. Lidocaine has numerous potential advantages over
 ropivacaine, such as faster onset of action, better safety profile and greater
 anti-inflammatory action. Catheters placed near both sides of a patient's spine for
 postoperative pain control are called thoracic paravertebral nerve blocks and are a part of
 routine care. Through those catheters, a "numbing" medication, or local anesthetic, to block
 the transmission of pain from the surgical incision to the spinal cord, thus reducing pain.
 The research part of the study is whether subjects will receive either the local anesthetic
 lidocaine or ropivacaine. The goal of this study is to determine whether the lidocaine
 controls pain better and facilitates a faster recovery after abdominal surgery than
 ropivacaine.

 In this research study, the investigators will compare patient-reported pain scores, any
 additional pain medication requirements for adequate pain control, time it takes for bowel
 function to return to normal following surgery, as well as the incidence of any side effects,
 such as numbness and weakness, subjects may experience between those receiving lidocaine
 versus those receiving ropivacaine. The investigators will screen 100 patients and enroll 60
 subjects into this study.
After determining eligibility, subjects will be enrolled in one of the two study groups on
 the day of surgery using a sealed envelope determined by a computer-generated list that made
 assignments randomly based on enrollment number. The study groups are defined as:

 Study group: Lidocaine 0.25%(L) 32 patients Control group: Ropivacaine 0.2%(R) 32 patients

 Paravertebral nerve block catheter placement and activation:

 After standard monitors and supplemental oxygen are applied, the patient will be placed in a
 sitting position. The two points of needle entry will be marked on the skin corresponding to
 each of the bilateral paravertebral catheter placements. The thoracic spine level will be at
 the anatomic level corresponding to the midpoint of the incision as determined by the surgeon
 preoperatively (range T7 to T11). The needle entry sites will be 2.5 cm lateral on each side
 of the midpoint of the spinous process of the corresponding thoracic vertebrae. The area will
 be prepared and draped in a sterile fashion, and 1% lidocaine infiltrated subcutaneously at
 each point of anticipated needle entry. For each of the two catheter placements, a sterile 18
 gauge Tuohy needle (B. Braun Medical, Inc., Perifix Continuous Epidural Anesthesia Set,
 Product Code CE18T) will be introduced perpendicularly to the skin until the transverse
 process is encountered, and the depth to the skin will be noted. The needle will then be
 readjusted in a caudad direction and inserted inferior to the corresponding transverse
 process to a depth approximately 1 cm deep to the transverse process. After final needle
 placement, a hanging drop technique will be used to rule out intrapleural placement while the
 patient inhales and exhales deeply. Next 5 mL of 0.5% Ropivacaine will be injected
 incrementally through each needle after negative aspiration, followed by insertion of the
 nerve block catheter to a depth 5 cm beyond the tip of the needle. An additional 10 mL of
 0.5% Ropivacaine will then be injected in 5 mL increments with negative aspiration in
 between, through each catheter yielding a total activation dose of 15 ml of 0.5% Ropivacaine
 on each side. The catheters will be secured with Steri-strips and a transparent occlusive
 dressing. Vital signs will be monitored by the nurse at regular intervals until the patient
 is taken to the operating room.

 Postoperative Management:

 Post Anesthesia Care Unit (PACU):

 Following routine intraoperative general anesthesia care, management in the post-anesthesia
 care unit will follow the standard of care for colorectal surgery. Bilateral paravertebral
 infusions of ropivacaine 0.2% or lidocaine 0.25% will be started at 7 mL/hr on each side for
 the patients depending which to group they were randomized. The patients in both groups will
 also be given access to PCA dilaudid (0.2 mg bolus, 8 min lockout, no basal infusion, no
 1-hour limit) once verbal pain score is ≤4. Additional pain relief is available via
 nurse-administered 10 mL/hour boluses of ropivacaine 0.2% or lidocaine 0.25% via the catheter
 pumps (5 mL each side for paravertebral group).This will be continued until the patient is
 able to tolerate oral pain medication. A single IV bolus of ketorolac at 7.5 mg will be
 available for additional pain management. Patient reported pain scores and total analgesic
 requirements will be recorded. Once adequate analgesia is established without any signs of
 adverse effects from the nerve blocks, the patients will be transferred to a hospital floor
 bed.

 Floors:

 After discharge from the PACU, additional pain relief is available via nurse-administered 3
 mL boluses of local anesthetic via the catheter pumps (3 mL each side for paravertebral
 group) given no more than hourly. In addition, nurse-administered intravenous boluses of
 dilaudid 0.3 mg every 30 minutes as needed up to 2 doses while the patient has PCA, and 0.8-1
 mg every hour as needed up to 4 doses in 2 hours once the patient is taking oral pain therapy
 and is off the PCA. All patients will be assessed daily by members of the acute
 interventional perioperative pain service. Also, a member of the acute pain service will be
 on-call 24 hours if inadequate pain control or side effects arise. The infusion rates via the
 paravertebral catheters may be adjusted at the discretion of the pain service up to a rate of
 10 mL/hr of either lidocaine 0.25% or ropivacaine 0.2% on each side (standard infusion rate
 used at UPMC). The PCA dose may be adjusted as deemed necessary by the acute pain team in
 order provide adequate analgesia. In addition 7.5mg IV of ketorolac may be administered every
 6 hours for the first 48 hours. Once the patient is able to tolerate oral liquids as
 determined by the surgeon, the PCA will be discontinued and oxycodone 5 mg available to the
 patient every 4 hours as needed for mild-moderate pain or oxycodone 10 mg every 6 hours as
 needed for severe pain. These doses may be adjusted as necessary by the pain service. All
 paravertebral catheters will be stopped and removed on the day after the patient has his/her
 first bowel movement or post-operative day #4, whichever occurs first. Pain scores collected
 by the nurses and supplemental analgesic requirements will be the data points for this study.
 Also, return of flatus and first bowel movement as documented in the AIPPS and surgery team's
 daily round notes will be recorded during the length of the hospitalization respectively.

 For each patient, the investigators collected numerical rating scores (NRS) for pain at rest
 and during movement at baseline, at postanesthesia care unit discharge, at 24 hours and 48
 hours after the end of surgery,
Inclusion Criteria:

 -  ASA I-III subjects

 -  Ages 18-80 years

 -  Weight between 60 and 110 Kg

 -  At least 60in (152cm) tall

 -  Scheduled for elective open colonic surgery at UPMC Presbyterian Shadyside Hospital in
 Pittsburgh, Pennsylvania

 Exclusion Criteria:

 -  Age younger than 18 years or older than 80 years

 -  Any contraindication to the placement of bilateral thoracic paravertebral catheters

 -  American Society of Anesthesiologists physical status IV or greater

 -  Chronic painful conditions

 -  Preoperative opioid use

 -  Coagulation abnormalities or patients who are expected to be on therapeutic
 anticoagulants postoperatively

 -  Allergy to any of the drugs/agents used study protocol

 -  Personal or family history of malignant hyperthermia

 -  Serum creatinine greater than 1.3 g/dl

 -  Pregnancy

 -  Having an altered mental status (not oriented to place, person, or time)

 -  Emergency surgery and those with sepsis, unstable angina, congestive heart disease,
 valvular heart disease, and severe COPD

 -  Patient's inability to provide adequate informed consent

 -  Non-english speaking

 -  Patient refusal