Influence of Epidural Analgesia in Elective Laparoscopic... | NCT00512395

Studies
Influence of Epidural Analgesia in Elective Laparoscopic Colorectal Resections

NCT00512395

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

Mar 19, 2024Actual

Enrollment

75Actual

Phase

Phase 4

Conditions

Pain

Interventions

epidural analgesia (Duracain/Fentanyl/Naropin)

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2004

Primary Completion Date

Not provided

Completion Date

Jan 2007Actual

First Submitted Date

Aug 6, 2007

First Submission Date that Met QC Criteria

Aug 6, 2007

First Posted Date

Aug 7, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2024

Last Update Posted Date

Mar 19, 2024Actual

Name	Class
Triemli Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

All patients with elective, laparoscopic colorectal resection between November 2004 and January 2007 were included in the trial. The decision for epidural analgesia was made by the anaesthetist and the patient. Contraindications were previous back surgery, coagulopathy, severe spondylarthrosis and refusal by the patient as contraindications.

Primary outcome was subjective feeling postoperatively, assessed with a VAS for pain and cramps and amount of analgesics used. Secondary outcomes were duration of postoperative bowel dismotility (first flatus, first defecation, first solid food intake) and general and specific morbidity.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	epidural analgesia	Drug: epidural analgesia (Duracain/Fentanyl/Naropin)
2	No Intervention	traditional analgesia with opioids

Interventions

Name	Type	Description	Arm Group Labels	Other Names
epidural analgesia (Duracain/Fentanyl/Naropin)	Drug	naropin 0.3% or duracain 0.125% + Fentanyl via epidural catheter 4-12 ml/h	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pain (VAS), cramps (VAS) and quantity of analgesics		8 days

Secondary Outcomes

Measure	Description	Time Frame
duration of postoperative ileus morbidity		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

elective laparoscopic colorectal resection

Exclusion Criteria:

emergency surgery
preoperatively planned stoma formation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Urs Zingg, MD	University Hospital, Basel, Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Triemli Hospital		Zurich			Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015360	Analgesia, Epidural

Ancestor Terms

ID	Term
D000698	Analgesia
D000760	Anesthesia and Analgesia

Browse Leaves

Not provided

Browse Branches

Not provided