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

Sigmoidal Tumour Clinical Trial

— 2013/004  

Official title:

RANDOMISED STUDY ABOUT POTSOTERATORY PAIN CONTROL IN LAPAROSCOPIC SIGMOIDECTOMY

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01825993
• Other study ID #: CIR TAP 2013
• Secondary ID: 2013-000556-17
• Status: Not yet recruiting
• Phase: Phase 3
• First received: March 29, 2013
• Last updated: April 5, 2013
• Start date: April 2013
• Est. completion date: April 2015

Study information

• Verified date: April 2013
• Source: Corporacion Parc Tauli
• Contact: MORA L. LAURA, MD
• Phone: 34937231010
• Email: Lmora[@]tauli.cat
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 225
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Sigmoidal Tumour

Intervention

Drug:
• L-BUPIVACAINE ; MORPHINE

• MORPHINE

Locations

Country	Name	City	State
Spain	Corporacion Parc Tauli	Sabadell	Sabadell-Barcelona
Spain	Corporacion Parc Tauli	Sabadell	Sabadell-barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EVA (POSTOPERATIVE PAIN)	The investigators asked the patient the postoperative pain during teh first 72 hours by EVA scale.	72 H POSTOPERATIVE	Yes
Secondary	ADVERSE EFFECTS	the investigators look for adverse effects	five days	Yes