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Comparison of the Analgesic Effect Between Intrathecal Morphine and IV-fentanyl Patient Controlled Analgesia (ITM-IVPCA) and Epidural PCA (PCEA) in Patients Undergoing Gastrectomy -Randomized Allocation Study-

Comparison of the Analgesic Effect Between Intrathecal Morphine and IV-fentanyl Patient Controlled Analgesia (ITM-IVPCA) and Epidural PCA (PCEA) in Patients Undergoing Gastrectomy -Randomized Allocation Study-

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01234272
Enrollment
59
Registered
2010-11-04
Start date
2010-08-31
Completion date
2011-06-30
Last updated
2011-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

patients with, undergoing, gastrectomy

Brief summary

The present study was designed to assess analgesic capacity of intrathecal administration of morphine combined with intravenous fentanyl patient-controlled analgesia (ITM-PCA) compared to patient controlled epidural analgesia using fentanyl and repivacaine (PCEA) in patients undergoing gastrectomy. The investigators hypothesized that ITM-PCA would show comparable analgesic effect to PCEA in gastrectomy.

Interventions

DRUGmorphine

ITM-IVPCA: intrathecal administration of 0.3 mg morphine before induction of general anesthesia and application of IVPCA (basal infusion: fentanyl 0.4mcg/kg/hr, bolus: 0.16mcg/kg of fentanyl with a lock out time of 15 min)

DRUGRopivacaine

PCEA: epidural administration of 5ml 0.2% ropivacaine before induction of general anesthesia and application of PCEA (basal infusion: 5ml 0.2% ropivacaine with fentanyl 0.4 mcg/kg/hr, bolus: 2ml 0.2% ropivacaine with fentanyl 0.16mcg/kg with a lockout time 15min)

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* I or II of preoperative physical status classification by the American Society of Anesthesiologists. * more than 20 years old. * undergoing gastrectomy due to gastric cancer.

Exclusion criteria

* contraindication to regional anesthesia technique (bleeding diasthesis, sepsis etc) or spine anomaly. * prior history of abdominal surgery or spine surgery.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026