Sigmoidal TumourPhase 32013/004NCT01825993
RANDOMISED STUDY OF EPIDURAL VS MPCA MORPHINE VS TAPP IN LAPAROSCOPIC SIGMOIDECTOMY
A Phase 3 study testing L-BUPIVACAINE ; MORPHINE and MORPHINE in people with Sigmoidal Tumour, run by Corporacion Parc Tauli at 2 sites in Spain.
Trial summary
The investigators would study the control of postoperative pain with peridural catheter, morphine PCA ev or Transabdominal block. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sigmoidal Tumour
- What is being tested?
- L-BUPIVACAINE ; MORPHINE and MORPHINE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 2 sitesSpain
- Study dates
- Apr 2013to Apr 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age more than 18
- Laparoscopic sigmoidectomy
- Informed consent firmed
Who cannot join
- ASA IV
- Urgent surgery
- Sigmoid tumour stage IV
- Cronic pain treatment
- No informed consent firmed
- Paliative surgery
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Corporacion Parc Tauli
Sabadell, Sabadell-Barcelona, 08208
Mora L Laura, MD, 34 937231010 ext. 24190, Lmora@tauli.cat
Corporacion Parc Tauli
Sabadell, Sabadell-barcelona, 08208
MORA L LAURA, MD, 34937231010 ext. 21490, Lmora@tauli.cat
mora
About this study
Official title: RANDOMISED STUDY ABOUT POTSOTERATORY PAIN CONTROL IN LAPAROSCOPIC SIGMOIDECTOMY
The investigators would study the control of postoperative pain with peridural catheter, morphine PCA ev or Transabdominal block.
- Conditions
- Sigmoidal Tumour
- Being tested
- L-BUPIVACAINE ; MORPHINE, MORPHINE
- Keywords
- Peridural catheter, Morphine PCA, Transabdominal Block, laparoscopic sigmoidectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-BUPIVACAINE ; MORPHINEDrug
Also called PERIDURAL L-BUPIVACAINE, PCA MORPHINE
MORPHINEDrug
| Study group | Role | What they receive |
|---|---|---|
| PCA endovenous | Experimental | 1mg/10 min Morphine Receives: Drug: MORPHINE |
| PERIDURAL CATHETER | Active comparator | Peridural L-bupivacaine 0.25% Receives: Drug: L-BUPIVACAINE ; MORPHINE |
| TANSABDOMINAL BLOCK (TAP) | Active comparator | L-BUPIVACAINE im Receives: Drug: L-BUPIVACAINE ; MORPHINE |
What is being measured
The primary outcome is the main question the study is designed to answer.
EVA (POSTOPERATIVE PAIN)
The investigators asked the patient the postoperative pain during teh first 72 hours by EVA scale.
Measured: 72 H POSTOPERATIVE
Secondary outcomes (1)
ADVERSE EFFECTS
the investigators look for adverse effects
Measured: five days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sigmoidal TumourStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LAURA MORA LOPEZ, Corporacion Parc Tauli
- Investigators
- PUJOL GEMMA, MD, Principal investigator, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825993
- Sponsor's protocol ID
- CIR TAP 2013
- Other IDs
- 2013-000556-17
- Acronym
- 2013/004
- Status last verified
- Apr 2013
- First submitted
- 29 Mar 2013
- Last updated
- 8 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RANDOMISED STUDY ABOUT POTSOTERATORY PAIN CONTROL IN LAPAROSCOPIC SIGMOIDECTOMY
- ClinicalTrials.gov ID
- NCT01825993
- Acronym / sponsor ID
- 2013/004 / CIR TAP 2013
- Conditions
- Sigmoidal Tumour
- Keywords
- Peridural catheter, Morphine PCA, Transabdominal Block, laparoscopic sigmoidectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 8 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators would study the control of postoperative pain with peridural catheter, morphine PCA ev or Transabdominal block.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PCA endovenous | Experimental | Drug: MORPHINE1mg/10 min Morphine |
| PERIDURAL CATHETER | Active comparator | Drug: L-BUPIVACAINE ; MORPHINEPeridural L-bupivacaine 0.25% |
| TANSABDOMINAL BLOCK (TAP) | Active comparator | Drug: L-BUPIVACAINE ; MORPHINEL-BUPIVACAINE im |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age more than 18
- Laparoscopic sigmoidectomy
- Informed consent firmed
Key exclusion criteria (6 listed)
- ASA IV
- Urgent surgery
- Sigmoid tumour stage IV
- Cronic pain treatment
- No informed consent firmed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-BUPIVACAINE ; MORPHINEAlso: PERIDURAL L-BUPIVACAINE, PCA MORPHINE | Drug | PERIDURAL CATHETER, TANSABDOMINAL BLOCK (TAP) |
| MORPHINE | Drug | PCA endovenous |
Primary outcome
EVA (POSTOPERATIVE PAIN)
Time frame: 72 H POSTOPERATIVE
The investigators asked the patient the postoperative pain during teh first 72 hours by EVA scale.
1 secondary outcome
ADVERSE EFFECTS
Time frame: five days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PUJOL GEMMA, MD principal investigator
Corporacion Parc Tauli
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing L-BUPIVACAINE ; MORPHINE and MORPHINE in people with Sigmoidal Tumour, run by Corporacion Parc Tauli at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MORA L. LAURA, MD (34937231010 ext. 21490, Lmora@tauli.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EVA (POSTOPERATIVE PAIN) (time frame: 72 H POSTOPERATIVE). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2013; AzTrials last refreshed its copy on 31 Oct 2026.