RANDOMISED STUDY OF EPIDURAL VS MPCA MORPHINE VS TAPP IN LAPAROSCOPIC SIGMOIDECTOMY (2013/004)

Corporacion Parc Tauli

Status and phase: Unknown; Phase 3

Conditions: Sigmoidal Tumour

Treatments: Drug: L-BUPIVACAINE ; MORPHINE; Drug: MORPHINE

Study type: Interventional

Funder types: Other

Identifiers

NCT01825993

CIR TAP 2013

2013-000556-17 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 225 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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225 participants in 3 patient groups

PCA endovenous

Experimental group

Description:

1mg/10 min Morphine

Treatment:

Drug: MORPHINE

PERIDURAL CATHETER

Active Comparator group

Description:

Peridural L-bupivacaine 0.25%

Treatment:

Drug: L-BUPIVACAINE ; MORPHINE

TANSABDOMINAL BLOCK (TAP)

Active Comparator group

Description:

L-BUPIVACAINE im

Treatment:

Drug: L-BUPIVACAINE ; MORPHINE