ON-Q Pump Infusion of Ketorolac and Ropivacaine at the Wound Site for Postoperative Pain Management

NCT00638508 | Completed Phase 4 Results DMC

• 1 other identifier: 06/07/VA3
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

After surgery it is normal to experience some pain at the site of operation. In order to reduce the pain, medication such as Morphine is injected into a vein using a Patient Controlled Analgesia (PCA) pump that is kept at bed side, and is activated by the patient when needed. However, Morphine is an opioid drug, which can cause side effects such as sedation, nausea, vomiting, and reduced breathing on prolonged use. In addition to the opioid drugs, local anesthetics, and other drugs called Non steroidal anti inflammatory drugs (NSAIDs) have been injected locally to provide prolonged pain relief without the side effects of morphine. Recently a portable device called ON-Q pump has been developed to continuously infuse the local anesthetic through 2 small catheters inserted at the wound site. The ON-Q Pump is a small tennis ball sized unit made of a soft synthetic material that slowly infuses the drug through the catheters by elastic force. This pump is very safe and is attached to a bedside pole or the patient's hospital gown. This pump has already been approved by the FDA for clinical use, and has been reported to provide effective pain management after some surgical procedures. The primary aim of the present study is to evaluate the relative efficacy of the drugs Ketorolac and Ropivacaine infused through the ON-Q pump in reducing the pain following gynecologic surgery. Ketorolac and Ropivacaine are approved drugs that are frequently used for post operative pain relief. Our hypothesis is that these two drugs in combination will provide better analgesia than Ketorolac alone.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (9)

• Pain Scores at Rest

  Patients report pain scores at rest using Visual Analog Scale (VAS). This scale measures the severity of pain and ranges from from 1-10, "1" being minimal pain intensity and "10" being maximal pain intensity.

  1 hour after the surgery

• Pain Score at Rest

  Patients report pain scores at rest using Visual Analog Scale (VAS). This scale measures the severity of pain and ranges from 1-10, "1" being minimal pain intensity and "10" being maximal pain intensity.

  At the end of 6 hours after surgery

• Pain Scores at Rest

  Pain scores at rest were measured using the Visual Analog Scale (VAS) at the end of 48 hours. This scale measures the severity of pain and ranges from 1-10, "1" being minimal pain intensity and "10" being maximal pain intensity.

  48 hours after surgery

• Pain Score on Coughing

  Pain scores on coughing were measured using the Visual Analog Scale (VAS) at the end of 48 hours. This scale measures the severity of pain and ranges from 1-10, "1" being minimal pain intensity and "10" being maximal pain intensity.

  1 hour after the surgery

• Pain Scores on Coughing

  Pain scores on coughing were measured using the Visual Analog Scale (VAS) at the end of 6 hours after surgery. This scale measures the severity of pain and ranges from 1-10, "1" being minimal pain intensity and "10" being maximal pain intensity.

  6 hours after surgery

• Pain Scores on Coughing

  Pain scores on coughing were measured using the Visual Analog Scale (VAS). This scale measures the severity of pain and ranges from 1-10, "1" being minimal pain intensity and "10" being maximal pain intensity.

  48 hours after surgery

• Pain on Movement

  Pain scores on movement was assessed using the Visual Analog Scale (VAS). This scale measures the severity of pain and ranges from 1-10, "1" being minimal pain intensity and "10" being maximal pain intensity.

  1 hour after surgery

• Pain Scores on Movement

  Pain scores on movement were assessed using the Visual Analog Scale (VAS) at the end of 6 hours. This scale measures the severity of pain and ranges from 1-10, "1" being minimal pain intensity and "10" being maximal pain intensity.

  6 hours after surgery

• Pain on Movement

  Pain scores on movement were measured 48 hours after surgery using the Visual Analog Scale (VAS). This scale measures the severity of pain and ranges from 1-10, "1" being minimal pain intensity and "10" being maximal pain intensity.

  48 hours afetr surgery

Secondary Outcomes (11)

• Morphine Equivalents Utilization

  1 hour after surgery

• Morphine Equivalents

  12 hours after surgery

• Morphine Equivalents

  48 hours afetr surgery

• DROWSINESS

  1 hour after surgery

• DROWSINESS

  48 hours

Study Arms (2)

Ketorolac

ACTIVE COMPARATOR

Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day

Drug: Ketorolac

Ketorolac with Ropivacaine

EXPERIMENTAL

Patients will receive Ketorolac 5 mg and Ropivacaine 0.5% (Group 2) via an infusion catheter at the incision site

Drug: Ketorolac and Ropivacaine

Interventions

Ketorolac DRUG

Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day

Also known as: Toradol

Ketorolac

Ketorolac and Ropivacaine DRUG

Patients will receive Ketorolac at 5 mg/hr plus 0.5% Ropivacaine

Also known as: Toradol and Naropin

Ketorolac with Ropivacaine

Eligibility Criteria

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

You may qualify if:

• Patients belonging to ASA class I to II classification who are undergoing abdominal gynecologic surgery will be included in the study.

You may not qualify if:

• Patients who are allergic to NSAIDs, Asthmatics, and those who have peptic ulcer, sepsis, or coagulation problems will be excluded from the study.

Sponsors & Collaborators

• Maimonides Medical Center: lead
• I-Flow: collaborator

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ketorolac; Ketorolac Tromethamine; Ropivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Kalpana Tyagaraj, M.D.
• Organization: Maimonides Medical Center

Kalpana_tyagaraj@msn.com

718-283-9162

Study Officials

• Kalpana Tyagaraj, M.D.

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending, Anesthesiology

Study Record Dates

• First Submitted: March 12, 2008
• First Posted: March 19, 2008
• Study Start: June 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: August 7, 2018
• Results First Posted: August 7, 2018

Record last verified: 2018-07

Locations

US (1)