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
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
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
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
NCT ID
NCT01095575
First Posted
March 28, 2010
Last Updated
April 9, 2010
Sponsor
Tel-Aviv Sourasky Medical Center
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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