RANDOMISED STUDY OF EPIDURAL VS MPCA MORPHINE VS TAPP IN... | NCT01825993

Studies
RANDOMISED STUDY OF EPIDURAL VS MPCA MORPHINE VS TAPP IN LAPAROSCOPIC SIGMOIDECTOMY

NCT01825993

Sponsor

Corporacion Parc Tauli

Status

Unknown status

Last Update Posted

Apr 8, 2013Estimated

Enrollment

225Estimated

Phase

Phase 3

Conditions

Sigmoidal Tumour

Interventions

L-BUPIVACAINE ; MORPHINE
MORPHINE

Countries

Spain

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

ID	Type	Description	Link
2013-000556-17	EudraCT Number

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Apr 2015Estimated

Completion Date

Apr 2015Estimated

First Submitted Date

Mar 29, 2013

First Submission Date that Met QC Criteria

Apr 5, 2013

First Posted Date

Apr 8, 2013Estimated

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

Apr 5, 2013

Last Update Posted Date

Apr 8, 2013Estimated

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

The investigators would study the control of postoperative pain with peridural catheter, morphine PCA ev or Transabdominal block.

Detailed Description

Not provided

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

225Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PCA endovenous	Experimental	1mg/10 min Morphine	Drug: MORPHINE
PERIDURAL CATHETER	Active Comparator	Peridural L-bupivacaine 0.25%	Drug: L-BUPIVACAINE ; MORPHINE
TANSABDOMINAL BLOCK (TAP)	Active Comparator	L-BUPIVACAINE im	Drug: L-BUPIVACAINE ; MORPHINE

Interventions

Name	Type	Description	Arm Group Labels	Other Names
L-BUPIVACAINE ; MORPHINE	Drug		PERIDURAL CATHETER TANSABDOMINAL BLOCK (TAP)	PERIDURAL L-BUPIVACAINE

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
EVA (POSTOPERATIVE PAIN)	The investigators asked the patient the postoperative pain during teh first 72 hours by EVA scale.	72 H POSTOPERATIVE

Secondary Outcomes

Measure	Description	Time Frame
ADVERSE EFFECTS	the investigators look for adverse effects	five days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age more than 18
Laparoscopic sigmoidectomy
Informed consent firmed

Exclusion Criteria:

ASA IV
Urgent surgery
Sigmoid tumour stage IV
Cronic pain treatment
No informed consent firmed
Paliative surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
MORA L. LAURA, MD	Contact	34937231010	21490	Lmora@tauli.cat

Overall Officials

Name	Affiliation	Role
PUJOL GEMMA, MD	Corporacion Parc Tauli	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Corporacion Parc Tauli		Sabadell	Sabadell-Barcelona	08208	Spain

Intervention Browse Module

MeSH Terms

ID	Term
D000077554	Levobupivacaine
D009020	Morphine

Ancestor Terms

ID	Term
D002045	Bupivacaine
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Browse Leaves

Not provided

Browse Branches

Not provided