Overview
Sponsor-declared trial summary
Colorectal cancer
To compare postoperative pain between two analgesic techniques: transversus abdominis plane block and infiltration of laparoscopy port wounds with local anesthetic.
Key facts
- Sponsor
- Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]
- Decision date (initial)
- 2024-09-03
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Hospital Universitario Doctor Peset · Fundacion FISABIO
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Dose response, Efficacy
To compare postoperative pain between two analgesic techniques: transversus abdominis plane block and infiltration of laparoscopy port wounds with local anesthetic.
Secondary objectives 5
- comparing opioid consumption postoperatively
- determining the incidence of postoperative nausea and vomiting
- comparing patient satisfaction
- determining the duration of hospital stay
- assessing intra- and postoperative glycemia
Conditions and MedDRA coding
Colorectal cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10061451 | Colorectal cancer | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Patients > 18 years old.
- Scheduled for laparoscopic colorectal cancer surgery (right hemicolectomy, left hemicolectomy, total colectomy, abdominoperineal resection of the rectum, low or ultra-low anterior resection of the rectum).
Exclusion criteria 7
- • Urgent colorectal cancer surgery.
- Allergy to local anesthetics.
- Patient refusal to undergo analgesic techniques.
- Patient refusal to participate in the study.
- BMI > 35 or < 50 kg.
- Chronic opioid therapy
- Communication difficulties due to language barrier or pathology.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Pain intensity measured with the visual analog scale (VAS),
Secondary endpoints 2
- Consumption of minor and major opioids during admission: The milligrams of minor (tramadol) and major (morphine) opioids administered to the patient will be recorded. Data collection times will be the same as for the VAS, at 2, 6, 24, and 48 hours after surgery completio
- Incidence of postoperative nausea and vomiting
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB08464MIG · Substance
- Active substance
- Levobupivacaine
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INFILTRATION
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 150 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana
- Sponsor organisation
- Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana
- Address
- Avenida Cataluna 21
- City
- Valencia
- Postcode
- 46020
- Country
- Spain
Scientific contact point
- Organisation
- Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana
- Contact name
- Juan Vicente Llau Pitarch
Public contact point
- Organisation
- Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana
- Contact name
- Juan Vicente Llau Pitarch
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 174 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-04 | Spain | Acceptable 2024-09-03
|
2024-09-03 |