Randomized clinical trial on patient-controlled epidural analgesia versus intravenous patient-controlled analgesia for laparoscopiccoloectomy within an enhanced recovery pathway.

Randomized clinical trial on patient-controlled epidural analgesia versus intravenous patient-controlled analgesia for laparoscopiccoloectomy within an enhanced recovery pathway. - RCT on PCEA vs iv-PCA for laparoscopic colorectomy within an enhanced recovery pathway

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000024358

Enrollment

110

Registered

2016-10-11

Start date

2016-11-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Colon cancer

Interventions

Pain control by epidural anesthesia with continuing administration of 0.125% levobupivacaine hydrochloride for 48 hours after surgery allowing the patient-controlled analgesia with bolus injection of

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Colon cancer patients 2. Histologically proven adenocarcinoma of the rectum 3. Adequate organ function 4. Performance status (PS) 0-2 5. Indication for laparoscopic surgery 6. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Indication for laparotomy 2. Indication for combined resection 3. Emergency case 4. With high risk factors for treatment delay of wound (active infection, uncontrolled diabetes mellitus, severe renal dysfunction, usage of immunosuppressive agent ) 5. Contraindication of PCEA 6. Contraindication of iv-PCA 7. Common use with drugs affecting pain control 8. With interstitial lung disease or pulmonary fibrosis 9. Pregnant 10. Patients who do not give written informed consent.

Design outcomes

Primary

Measure	Time frame
Medical recovery defined as the fulfillment of all the 3 following criteria: (1) sufficient pain control by oral analgesics, (2) fully mobilized or at least comparable with preoperative status, and (3) tolerance of oral food that was defined as two thirds or more of normal meal (hospital portion)	—

Secondary

Measure	Time frame
1.Time periods of anesthesia in preparation for and during surgery 2.Pain score (VAS) during the first to fifth postoperative day 3.Postoperative general status 4.Total dose of analgesic drug used for PCEA / iv-PCA 5.Frequency of additional analgesic drug use for pain control 6.Occurrence rate and severity of adverse effects 7.Postoperative hospital stay	—

Countries

Japan

Contacts

Public ContactTatsuya Manabe,MD

Graduate School of Medical Sciences, Kyushu University Surgery and Oncology

manabe@surg1.med.kyushu-u.ac.jp092-642-5440

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026