Effects of a Combination of IV-PCA With Continuous IV Infusion of MO, Versus IV-PCA MO on Postoperative Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00849719
First received: February 17, 2009
Last updated: February 23, 2009
Last verified: February 2009
  Purpose

After major surgery, such as abdominal or thoracic surgery, the majority of patients experience moderate to severe pain that may not be optimally controlled. Inadequate pain relief may lead to complications that can hinder rehabilitation and slow recovery. Morphine (MO) is the most commonly used opioid for the treatment of post-surgical pain (14). The preferred method of administration nowadays is intravenous patient-controlled analgesia (PCA). In contrast, Continuous infusion of intravenous morphine (CIVM) is seldom used in Post-Anesthesia Care Units (PACUs) for acute postoperative pain, due to concerns of cardio-respiratory deterioration, even though different studies have found this technique of administration effective and safe (in terms of opioid-related symptoms.As part of our efforts to improve postoperative pain management in the Tel Aviv Sourasky Medical Center's PACU, we wish to determine if combining CIVM with IV PCA will be superior over IV PCA only for the treatment of postoperative pain following major abdominal or thoracic surgery.Our hypothesis is that the continuous infusion, even if given at a relatively low dose, would enable the build-up of pharmacologically effective MO blood level, thus providing an overall better control of pain.


Condition Intervention
Post Operative Pain
Drug: a combination of PCA MO and continuous infusion of MO
Drug: PCA MO only

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effects of Combination of Continuous Intravenous (IV) Infusion Plus Patient-Controlled Analgesia (PCA) of Morphine (MO) vs. IV-PCA MO on Postoperative Pain Control

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • demand/delivery ratio for MO and rescue drug [ Time Frame: hourly and 12 h total drug consumption ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pain intensity [ Time Frame: hourly ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: April 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients in this arm will recieve a combination of PCA MO (10 ug/kg/bolus, by request) and continuous infusion of MO (10 ug/kg/h), when visual analog scale (VAS) exeeds 5/10 boluses will be self-administered by the patient.
Drug: a combination of PCA MO and continuous infusion of MO
Patients in this arm will recieve a combination of PCA MO (10 ug/kg/bolus, by request) and continuous infusion of MO (10 ug/kg/h), when visual analog scale (VAS) exeeds 5/10 boluses will be self-administered by the patient. Rescue diclofenac 75 mg IM will be allowed once to help prompt start analgesia instead of opioid titration, and 6h later. No hourly dose limit will be set for the protocols.
Other Name: PCA and infusion MO
Active Comparator: 2
Patients in this arm will be administered with only boluses of 1.5 mg/bolus of MO, by request.
Drug: PCA MO only
When visual analog scale [VAS] exeeds 5/10, and after the PACU drug-blinded attending physician had established that the patient is coherent and cooperative, a PCA system will be connected to the patient's IV line. The physician will start device, and deliver the first bolus. The subsequent drug boluses will be self-administered by the patient. Group 2 will be administered with only boluses of 1.5 mg/bolus of MO, by request. Rescue diclofenac 75 mg IM will be allowed once to help prompt start analgesia instead of opioid titration, and 6h later. No hourly dose limit will be set for the protocols.
Other Name: PCA MO

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing major abdominal procedures (e.g. laparotomy, nephrectomy, gastrectomy, gastric bypass, pancreatectomy, splenectomy, and abdominal aortic aneurysm) or thoracic surgery (segmentectomy, lobectomy or pneumonectomy) in our institution during the years 2008-9.

Exclusion Criteria:

  • patients with a history of drug or alcohol abuse, psychiatric disturbances, senile dementia, Alzheimer's disease, seizures or suicide risk, use of psychotropic drugs, pregnancy or nursing, hypersensitivity to MO, or to non steroidal anti-inflammatory drugs (NSAIDs) or their excipients, chronic or acute pain of any origin, respiratory failure or insufficiency, uncompensated or congestive heart or hepatic failure and those scheduled for an emergency or palliative procedure.
  • we will also exclude patients using antidepressants, anticonvulsants or muscle relaxants, and patients using any monoamine oxidase inhibitor within 2 weeks of surgery.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00849719

Contacts
Contact: Avi Weinbrum, MD 97236973237 draviw@tasmc.health.gov.il

Locations
Israel
Tel Aviv Sourasky medical center Not yet recruiting
Tel Aviv, Israel, 64239
Contact: Yifat Klein, PhD    9726974093    yifat.klein@gmail.com   
Principal Investigator: Avi Weinbrum, MD         
Sub-Investigator: Yifat Klein, PhD         
Sub-Investigator: Ron Fleishon, MD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Study Chair: Avi Weinbrum, MD Director Post Anesthesia Care Unit, TASMC
  More Information

Publications:
Responsible Party: Prof Avi Weinbrum, Director Post Anesthesia Care Unit, Tel Aviv Sourasky medical center
ClinicalTrials.gov Identifier: NCT00849719     History of Changes
Other Study ID Numbers: TASMC-08-AW-0400-CTIL
Study First Received: February 17, 2009
Last Updated: February 23, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
visual analog scale
patient controlled analgesia
post operative pain
rescue drug

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014