Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
60
Countries
1
Sites
1
Patients scheduled for laparoscopic colorectal surgery
To compare total perioperative opioid consumption in each of the study groups at 48h expressed as morphine milligram equivalent.
Key facts
- Sponsor
- Hospital Universitario La Paz
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Trial duration
- 16 Jan 2024 → ongoing
- Decision date (initial)
- 2023-10-30
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To compare total perioperative opioid consumption in each of the study groups at 48h expressed as morphine milligram equivalent.
Secondary objectives 4
- To compare total perioperative opioid consumption in each of the study groups at post-anesthesia recovery unit (PACU) and 24h after surgery.
- To compare postoperative pain score at rest and movement by visual analog scale (VAS) or numeric rate score (NRS) at post-anesthesia recovery unit, 24h and 48h after surgery.
- To determine if there is any difference in the incidence of nausea and vomiting at post-anesthesia recovery unit, 24h and 48h after surgery.
- To determine if there are differences in the onset of oral tolerance, ambulation movilization and length of hospital stay.
Conditions and MedDRA coding
Patients scheduled for laparoscopic colorectal surgery
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Phase IV, single-center, randomized, double-blind clinical trial, compared with clinical practice Phase IV, single-center, randomized, double-blind clinical trial, compared with clinical practice
|
Randomised Controlled | Double | [{"id":28411,"code":2,"name":"Investigator"},{"id":28410,"code":1,"name":"Subject"}] | TAP group:: After anesthetic induction, a bilateral transversus abdominis plane block will be performed under aseptic and ultrasound-guided conditions. 40 ml of Levobupivacaine 0.25% will be infiltrated, 20 ml on each side, between the transverse muscle and the external oblique muscle. The TAP block will be performed by an anesthesiologist. The trocars will then be inserted into the abdomen in the usual manner for this surgery and once the procedure is completed they will be removed. Wound infiltration group:: After anesthetic induction, the surgeon will infiltrate a total of 40ml of Levobupivacaine 0.25% prior to performing the laparoscopic ports, in the area where the incisions will be made. Then, the trocars will be inserted in the abdomen as usual in this surgery. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Patients scheduled for laparoscopic colorectal surgery (right or left hemicolectomy, extended hemicolectomy, high anterior resection, total colectomy or sigmoidectomy).
- Age >18 years.
- Completed informed consent. Patients who agrees to participate in the study by signing the informed consent.
- ASA 1-3
- Willingness to NOL monitor
Exclusion criteria 7
- Urgent surgery.
- Obesity grade II or higher (BMI >35kg/m2).
- Known allergy to local anesthetics or other drugs included in protocol.
- Psychiatric disturbances that prevent clinical assessment of pain.
- Absence of NOL monitor.
- Previous history of chronic pain with habitual opioid use.
- If the surgery is converted to open surgery, the patient will be excluded from the study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Difference between total opioid consumption of TAP group versus Wound Infiltration (WI) group 48h. after surgery.
Secondary endpoints 4
- Difference between total opioid consumption of TAP group versus Wound Infiltration (WI) group at post-anesthesia recovery unit (PACU) and 24h after surgery.
- Difference between pain score at rest and movement (by VAS or NRS) of TAP group versus Wound Infiltration (WI) group at post-anesthesia recovery unit (PACU), 24h. and 48h. after surgery.
- Difference between the incidence of nausea and vomiting of TAP group versus Wound Infiltration (WI) group at post-anesthesia recovery unit (PACU), 24h. and 48h. after surgery.
- Difference between the onset of oral tolerance, ambulation movilization and length of hospital stay of TAP group versus Wound Infiltration (WI) group.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Levobupivacaína Kabi 2,5 mg/ml solución inyectable y para perfusión EFG
PRD3167593 · Product
- Active substance
- Levobupivacaine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 100 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB10 — LEVOBUPIVACAINE
- Marketing authorisation
- 79845
- MA holder
- FRESENIUS KABI ESPAÑA S.A.U.
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Hospital Universitario La Paz
- Sponsor organisation
- Hospital Universitario La Paz
- Address
- Paseo Castellana 261
- City
- Madrid
- Postcode
- 28046
- Country
- Spain
Scientific contact point
- Organisation
- Hospital Universitario La Paz
- Contact name
- María Cristina Rodríguez Roca
Public contact point
- Organisation
- Hospital Universitario La Paz
- Contact name
- María Cristina Rodríguez Roca
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 60 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2024-01-16 | 2024-01-17 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-21 | Spain | Acceptable 2023-10-25
|
2023-10-30 |