NCT00512395

Brief Summary

Epidural anaesthesia in open surgery is a effective method for analgesia and has a positive effect on postoperative resolution of ileus. In laparoscopic surgery, the role of epidural surgery is not established. This prospective observational trial evaluates the effect of epidural analgesia in patients undergoing elective, laparoscopic colorectal surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for phase_4 pain

Timeline
Completed

Started Nov 2004

Typical duration for phase_4 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2007

Completed
Last Updated

March 19, 2024

Status Verified

March 1, 2024

First QC Date

August 6, 2007

Last Update Submit

March 18, 2024

Conditions

Pain

Keywords

laparoscopic colorectal surgeryepidural analgesiapain scorepostoperative ileus

Outcome Measures

Primary Outcomes (1)

  • pain (VAS), cramps (VAS) and quantity of analgesics

    8 days

Secondary Outcomes (1)

  • duration of postoperative ileus morbidity

    6 months

Study Arms (2)

1

ACTIVE COMPARATOR

epidural analgesia

Drug: epidural analgesia (Duracain/Fentanyl/Naropin)

2

NO INTERVENTION

traditional analgesia with opioids

Interventions

epidural analgesia (Duracain/Fentanyl/Naropin)DRUG

naropin 0.3% or duracain 0.125% + Fentanyl via epidural catheter 4-12 ml/h

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elective laparoscopic colorectal resection

You may not qualify if:

  • emergency surgery
  • preoperatively planned stoma formation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Triemli Hospital

Zurich, Switzerland

Location

MeSH Terms

Conditions

Pain

Interventions

Analgesia, Epidural

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnalgesiaAnesthesia and Analgesia

Study Officials

  • Urs Zingg, MD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 6, 2007

First Posted

August 7, 2007

Study Start

November 1, 2004

Study Completion

January 1, 2007

Last Updated

March 19, 2024

Record last verified: 2024-03

Locations

CH(1)