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

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ClinicalTrials.gov Identifier: NCT01095575
Recruitment Status : Completed
First Posted : March 30, 2010
Last Update Posted : April 12, 2010
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center

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.


Condition or disease Intervention/treatment Phase
Pain Drug: normal saline 3 ml, morphine 3mg Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Pre- vs. Post-Incisional Epidural Morphine: Higher Postoperative Pain Perception and Extra Morphine Consumption
Study Start Date : January 2006
Actual Study Completion Date : January 2008

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Arm Intervention/treatment
Active Comparator: group 1
NS preoperatively and MO postoperatively
Drug: normal saline 3 ml, morphine 3mg
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).

Active Comparator: group 2
MO preoperatively and NS postoperatively
Drug: normal saline 3 ml, morphine 3mg
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 Measures :
  1. Subjective pain intensity, using a visual analogue scale (VAS) from 0 (no pain) to 10 (unbearable pain) [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. Consumption of analgesics [ Time Frame: 48 hours ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers:   No
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:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01095575


Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
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Principal Investigator: Avraham Weinbroum, MD Tel Aviv Medical Center

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Responsible Party: Weinbroum Avraham, Tel Aviv Medical Center
ClinicalTrials.gov Identifier: NCT01095575     History of Changes
Other Study ID Numbers: weinbroum pain
First Posted: March 30, 2010    Key Record Dates
Last Update Posted: April 12, 2010
Last Verified: March 2010

Keywords provided by Tel-Aviv Sourasky Medical Center:
Epidural
Morphine
Preoperative
Postoperative
Analgesia
Tolerance
Preoperative, Postoperative Analgesia

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents