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Postoperative PainNCT02849678

A Pain Study Comparing Two Commonly Used Medications to Treat Pain After Bowel Surgery

A study testing Ropivacaine and Lidocaine in people with Postoperative Pain, run by Jacques E. Chelly at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Postoperative Pain
What is being tested?
Ropivacaine and Lidocaine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteUnited States
Study dates
Jan 2008to May 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UPMC Presbyterian Shadyside

    Pittsburgh, Pennsylvania, 15232

Other trials in United States

About this study

Official title: A Comparison of Lidocaine Versus Ropivacaine for Bilateral Continuous Thoracic Paravertebral Nerve Blocks for Post-bowel Surgery Analgesia

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.

Read the detailed description

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,

Being tested
Ropivacaine, Lidocaine
Keywords
Postoperative Pain, Bowel Surgery, Regional Anesthesia
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RopivacaineDrug

    Also called Naropin®, Ropivacaine hydrochloride

    0.5% Ropivacaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. It is the local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared.

  • LidocaineDrug

    Also called Xylocaine

    Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.

    At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia. There are several studies to support this as listed in the references. Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use.

Study groups in NCT02849678
Study groupRoleWhat they receive
LidocaineActive comparatorLidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia.Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use.
Receives: Drug: Lidocaine
RopivacaineActive comparatorRopivacaine is a local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared. Ropivacaine has been safely used in the paravertebral nerve blocks at our institution for several years.
Receives: Drug: Ropivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 11-point Verbal Numerical Rating Scale (NRS) Pain Assessment

    The primary outcome of the study is the NRS score for pain at rest at 24 hours. The NRS Pain Assessment requires patients to select a number between 0 - 10 where 0 is no pain and 10 is the worst imaginable pain. Patients pick one whole number on this scale to describe their pain.

    Measured: 24 hours from the end of surgery

Secondary outcomes (6)
  1. Time to First Ambulation(Walking Greater Than 15 Feet)

    During the hospitalization following surgery until discharge. Hospital length of stay ranged from 3 - 22 days following surgery.

    Measured: During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery)

  2. Time to First Flatus/Defecation

    During the hospitalization following surgery until discharge. Hospital length of stay ranged from 3 - 22 days following surgery.

    Measured: During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery)

  3. Hospital Length of Stay.

    During the hospitalization following surgery until discharge. Hospital length of stay ranged from 3 - 22 days following surgery.

    Measured: During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery)

  4. Number of Patients With Complications (Including But Not Limited to Pneumonia, Atelectasis, Hypotension, Motor Weakness, Etc.)

    During the hospitalization following surgery until discharge.

    Measured: During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery)

  5. Postoperative Opioid Consumption (Milligrams of Dilaudid or Equivalent)

    During the hospitalization following surgery until discharge. Hospital length of stay ranged from 3 - 22 days following surgery.

    Measured: During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery)

  6. Consumption of Nerve Block Boluses Will Also be Recorded Daily

    During the hospitalization following surgery until discontinuation of the block or discharge. Hospital length of stay ranged from 3 - 22 days following surgery.

    Measured: During the inpatient hospitalization (Hospital length of stay ranged from 3 - 22 days following surgery)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2016 (estimated)
  2. Study startJan 2008
  3. Primary completionNov 2013
  4. Study completionMay 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02849678
Sponsor's protocol ID
PRO07080230
Status last verified
Feb 2018
First submitted
22 Mar 2016
Last updated
20 Mar 2018
Data monitoring committee
No
Individual data sharing
Undecided: This data has been published.

Publications

  • Ghisi D, Fanelli A, Jouguelet-Lacoste J, La Colla L, Auroux AS, Chelly JE. Lidocaine versus ropivacaine for postoperative continuous paravertebral nerve blocks in patients undergoing laparoscopic bowel surgery: a randomized, controlled, double-blinded, pilot study. Local Reg Anesth. 2015 Sep 14;8:71-7. doi: 10.2147/LRA.S84476. eCollection 2015.

    PubMed 26396544

Questions about this trial

What is this clinical trial studying?

A study testing Ropivacaine and Lidocaine in people with Postoperative Pain, run by Jacques E. Chelly at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

11-point Verbal Numerical Rating Scale (NRS) Pain Assessment (time frame: 24 hours from the end of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02849678, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2018; AzTrials last refreshed its copy on 6 Nov 2026.

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