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

NCT00849719 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2009-02-24

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Principal Investigators

  • Avi Weinbrum, MD · Director Post Anesthesia Care Unit, TASMC

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-04-30
Completion
2010-06-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00849719 on ClinicalTrials.gov