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

NCT00849719 | Unknown DMC

• 1 other identifier: TASMC-08-AW-0400-CTIL
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Operative Pain

Keywords

visual analog scale; patient controlled analgesia; post operative pain; rescue drug

Outcome Measures

Primary Outcomes (1)

• demand/delivery ratio for MO and rescue drug

  hourly and 12 h total drug consumption

Secondary Outcomes (1)

• pain intensity

  hourly

Study Arms (2)

1

EXPERIMENTAL

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

2

ACTIVE COMPARATOR

Patients in this arm will be administered with only boluses of 1.5 mg/bolus of MO, by request.

Drug: PCA MO only

Interventions

a combination of PCA MO and continuous infusion of MO DRUG

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.

Also known as: PCA and infusion MO

1

PCA MO only DRUG

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.

Also known as: PCA MO

2

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Sourasky medical center

Tel Aviv, 64239, Israel

Location

Related Publications (1)

• Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E.

  PMID: 12873949 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Passive Cutaneous Anaphylaxis

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Antigen-Antibody Reactions; Immune System Phenomena

Study Officials

• Avi Weinbrum, MD

  Director Post Anesthesia Care Unit, TASMC

  STUDY CHAIR

Central Study Contacts

Avi Weinbrum, MD

CONTACT

97236973237; draviw@tasmc.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: February 17, 2009
• First Posted: February 24, 2009
• Study Start: April 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: June 1, 2010
• Last Updated: February 24, 2009

Record last verified: 2009-02

Locations

IL (1)