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

NCT02849678 | Completed Results

• 1 other identifier: PRO07080230
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Postoperative Pain

Keywords

Postoperative Pain; Bowel Surgery; Regional Anesthesia

Outcome Measures

Primary Outcomes (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.

  24 hours from the end of surgery

Secondary Outcomes (6)

• Time to First Ambulation(Walking Greater Than 15 Feet)

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

• Time to First Flatus/Defecation

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

• Hospital Length of Stay.

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

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

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

• Postoperative Opioid Consumption (Milligrams of Dilaudid or Equivalent)

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

Study Arms (2)

Lidocaine

ACTIVE COMPARATOR

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.Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use.

Drug: Lidocaine

Ropivacaine

ACTIVE COMPARATOR

Ropivacaine 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.

Drug: Ropivacaine

Interventions

Ropivacaine DRUG

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.

Also known as: Naropin®, Ropivacaine hydrochloride

Ropivacaine

Lidocaine DRUG

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.

Also known as: Xylocaine

Lidocaine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jacques E. Chelly: lead
• University of Pittsburgh: collaborator

Study Sites (1)

UPMC Presbyterian Shadyside

Pittsburgh, Pennsylvania, 15232, United States

Location

Related Publications (1)

• 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.

  PMID: 26396544 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine; Lidocaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides

Limitations and Caveats

This study did not provide information about the treatment drug mechanism of action, whether it is regional or systemic. Local anesthetic plasma concentration was not measured in this study either.

Results Point of Contact

• Title: Jacques E. Chelly, MD, PhD, MBA
• Organization: University of Pittsburgh Medical Center Department of Anesthesiology

chelje@anes.upmc.edu

412-623-6382

Study Officials

• Andrea Fanelli, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice Chair of Clinical Research

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: July 29, 2016
• Study Start: January 1, 2008
• Primary Completion: November 1, 2013
• Study Completion: May 1, 2016
• Last Updated: March 20, 2018
• Results First Posted: February 24, 2017

Record last verified: 2018-02

Locations

US (1)