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Pre- Versus Post-Incisional Epidural Morphine: Higher Postoperative Pain Perception and Extra Morphine Consumption

Primary Purpose

Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
normal saline 3 ml, morphine 3mg
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Epidural, Morphine, Preoperative, Postoperative, Analgesia, Tolerance, Preoperative, Postoperative Analgesia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)Does not accept healthy volunteers

Inclusion Criteria:

1.adults scheduled for elective laparotomy and colon surgery with the duration of surgery expected to last for at least 2 hours.

Exclusion Criteria:

  1. allergy to morphine, fentanyl, non-steroidal anti-inflammatory drugs or any of the intraoperative anesthetic medications
  2. use of opioids, sedatives or stimulants during 21 days prior to surgery, psychiatric illness
  3. congestive heart failure, respiratory failure, neuromuscular disease or presence of a chronic pain syndrome
  4. Pregnant women and patients unable to sign their own consent form

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    group 1

    group 2

    Arm Description

    NS preoperatively and MO postoperatively

    MO preoperatively and NS postoperatively

    Outcomes

    Primary Outcome Measures

    Subjective pain intensity, using a visual analogue scale (VAS) from 0 (no pain) to 10 (unbearable pain)

    Secondary Outcome Measures

    Consumption of analgesics

    Full Information

    First Posted
    March 28, 2010
    Last Updated
    April 9, 2010
    Sponsor
    Tel-Aviv Sourasky Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01095575
    Brief Title
    Pre- Versus Post-Incisional Epidural Morphine: Higher Postoperative Pain Perception and Extra Morphine Consumption
    Official Title
    Pre- vs. Post-Incisional Epidural Morphine: Higher Postoperative Pain Perception and Extra Morphine Consumption
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2006 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    January 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Tel-Aviv Sourasky Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Background and Objectives: Neuraxial administration of morphine is an effective way of controlling postoperative pain and reducing analgesic consumption. Several animal models have demonstrated that preemptive administration of neuraxial narcotics reduced pain while others revealed the induction of post-incisional hypersensitivity. There have been no consistent results in clinical setting either. This double blind, randomized study compared the effects of PRE- vs. POST-incisional administration of neuraxial morphine on postoperative pain perception and analgesic requirements over 48 hours following laparotomy for open colectomy under standardized general anesthesia. Methods: Twenty patients received epidural morphine (3 mg) pre-incision and saline after wound closure (MO1 group), and 20 patients received epidural saline before incision and morphine after wound closure (MO2 group). Postoperatively, all patients received boluses of morphine (1.5 mg) via intravenous patient-controlled analgesia (IV-PCA), and rescue doses of intramuscular diclofenac (75 mg) every 6 hours, as needed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain
    Keywords
    Epidural, Morphine, Preoperative, Postoperative, Analgesia, Tolerance, Preoperative, Postoperative Analgesia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    group 1
    Arm Type
    Active Comparator
    Arm Description
    NS preoperatively and MO postoperatively
    Arm Title
    group 2
    Arm Type
    Active Comparator
    Arm Description
    MO preoperatively and NS postoperatively
    Intervention Type
    Drug
    Intervention Name(s)
    normal saline 3 ml, morphine 3mg
    Intervention Description
    On the day of surgery, patients were brought to the operating room (OR) where routine monitors were placed and an epidural catheter was inserted at the level of L3-4 to a distance of 10 cm. All patients received two injections via the catheter: one injection contained 3 mg morphine (MO), and the other contained normal saline (NS) of the same volume. Patients were randomized to receive either NS preoperatively and MO postoperatively or vice versa. The first injection was administered 40 minutes before initiation of surgery, and the second one was given 15 minutes after surgery ended. All epidural catheters were removed before the patients were discharged from the post-anesthesia care unit (PACU).
    Primary Outcome Measure Information:
    Title
    Subjective pain intensity, using a visual analogue scale (VAS) from 0 (no pain) to 10 (unbearable pain)
    Time Frame
    48 hours
    Secondary Outcome Measure Information:
    Title
    Consumption of analgesics
    Time Frame
    48 hours

    10. Eligibility

    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 1.adults scheduled for elective laparotomy and colon surgery with the duration of surgery expected to last for at least 2 hours. Exclusion Criteria: allergy to morphine, fentanyl, non-steroidal anti-inflammatory drugs or any of the intraoperative anesthetic medications use of opioids, sedatives or stimulants during 21 days prior to surgery, psychiatric illness congestive heart failure, respiratory failure, neuromuscular disease or presence of a chronic pain syndrome Pregnant women and patients unable to sign their own consent form
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Avraham Weinbroum, MD
    Organizational Affiliation
    Tel Aviv Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Pre- Versus Post-Incisional Epidural Morphine: Higher Postoperative Pain Perception and Extra Morphine Consumption

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