Multimodal Anesthesia in Robotic Laparoscopic Nephrectomy (MANTRA)

Efficacy of Multimodal Anesthesia in Robotic Laparoscopic Nephrectomy: Impact on Recovery and Early Hospital Discharge.

It is a prospective, randomized, controlled and superiority clinical trial, with the objective of comparing the effectiveness of multimodal anesthesia versus conventional anesthesia in patients undergoing oncological robotic nephrectomy within a short-stay surgery program (SSA). The effect of no specific drug will be evaluated, but rather the anesthetic approach ologies of surgical patients. The clinical trial will be carried out in a third-level university hospital, between the first half of 2026 and the second half of 2027 and, after approval by the corresponding Clinical Research Ethics Committee.

Study Overview

• Status: Not yet recruiting
• Conditions: Anesthesia; Anesthesia and Procedure Related Time Intervals; Nephrectomy / Methods
• Intervention / Treatment: Drug: Multimodal anesthesia; Drug: Conventional anesthesia

Detailed Description

Prospective, randomized, controlled clinical trial to evaluate whether multimodal anesthesia allows for early hospital discharge (reduce 24-hour admission) compared to conventional anesthesia in oncological robotic nephrectomies; both according to usual practice. The effect of no specific drug will be evaluated, but rather the anesthetic approach pologies of surgical patients. It will be enrolled 80 patients. Patients will be randomized 1:1 using a computer-generated sequence into: Group A: multimodal anesthesia vs Group B: conventional anesthesia.

Main objective is to demonstrate the superiority of multimodal anesthesia over conventional anesthesia in patients undergoing robotic laparoscopic nephrectomy within a short-stay surgical program, in terms of reducing hospital admission time and earlier discharge. To demonstrate that multimodal anesthesia allows a reduction in hospital admission time allowing for early discharge.

Estimated duration of the study is 18 months. This involves collecting data from preoperative to 30 days post-surgery from patients undergoing oncological robotic nephrectomy.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: DIANA VERNETTA, MD; Phone Number: 0034934169700; Email: dvernetta@fundacio-puigvert.es

Study Locations

• Spain
  • BARCELONA
    • Barcelona, BARCELONA, Spain, 08025
      • Fundacio Puigvert
      • Contact: DIANA VERNETTA, MD; Phone Number: 0034934169700; Email: dvernetta@fundacio-puigvert.es
      • Contact: Silvia Mateu, MD; Phone Number: 0034 934169700; Email: smateu@fundacio-puigvert.es
      • Principal Investigator: DIANA VERNETTA, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients ≥18 years.
• Indication for elective oncological robotic partial or radical nephrectomy.
• ASA classification I-III.
• Candidates for short-stay surgery according to institutional protocol.
• Signed informed consent.

Exclusion Criteria:

• Chronic opioid use. Defined as continuous opioid use during the 3 months prior to surgery
• Uncontrolled chronic pain. Defined as chronic pain not adequately controlled with usual treatment during the 3 months prior to surgery.
• Contraindications to NSAIDs, regional anesthesia, or drugs of the multimodal protocol.
• Advanced renal failure (GFR <30 ml/min) at the preanesthetic visit.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Multimodal anesthesia; Multimodal anesthesia Balanced general anesthesia. Standardized multimodal analgesia: Paracetamol iv NSAID or COX-2 (if not contraindicated) Magnesium sulfate iv Lidocaine iv Ketamine iv Methadone iv at the beginning surgical incision at low doses TAP block with local anesthetic: Bupivacaine 0.25% 10ml Surgical wound infiltration with local anesthetic: bupivacaine 0.25% 2ml per to knock	Drug: Multimodal anesthesia; Administration of multimodal anesthesia in patients randomized to this arm and undergoing oncological robotic nephrectomies according to usual practice. Premedication: Midazolam: 1-2mg Ondansetron: 4-8mg IV Dexamethasone: 4-8mg IV +/-Scopolamine (patients high risk PONV) iv Magnesi Sulfate: 30-50mg/Kg iv Induction: Fentanyl: 1mcg/kg iv Propofol: 1-2mg/Kg iv Rocuroni: 0.3mg/kg iv Lidocaine: 1.1.5mg/Kg iv bolus Ketamine: 0.25-0.5mg/Kg Methadone: 0.5-0.1mg/kg IV at the beginning of the surgical incision (single dose). Maintenance: Propofol/sevorane Rocuroni: 0.3mg/kg/h iv Lidocaine: 1-2 mg/Kg/h Ketamine: 0.1-0.2 mg/kg/h Postoperative: Paracetamol: 1g/8h IV Metamizole: 1g/8h iv Rescue opioids if VAS>4: Adolonta or Morphine
Active Comparator: Conventional anesthesia; Balanced general anesthesia. Standardized conventional analgesia: Paracetamol IV NSAID or COX-2 (if not contraindicated) Analgesia based mainly on systemic opioids. Absence of protocolized regional blocking.	Drug: Conventional anesthesia; Administration of conventional anesthesia in patients randomized to this arm and undergoing oncological robotic nephrectomies according to usual practice. Premedication: Midazolam: 1-2mg Ondansetron: 4-8 mg IV Dexamethasone: 4-8 mg IV +/-Scopolamine (patients high risk PONV) iv Induction: Fentanyl: 1mcg/kg iv Propofol: 1-2mg/kg iv Rocuroni: 0.3mg/kg iv Maintenance: Propofol/sevorane Rocuroni: 0.3mg/kg/h iv Remifentanil: 0.05-0.2 mcg/Kg/h Methadone: 1-1.5mg/kg IV at the end of surgery Postoperative: Paracetamol: 1g/8h IV Metamizole: 1g/8h iv Rescue opioids if VAS>4: Adolonta or Morphine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change hospital admission time and earlier discharge	Changes over time in the hospital stay, expressed in hours, will be measured and reported.	From enrollment to the end of follow up 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post surgery pain	Postoperative pain will be assessed using the VAS scale (Visual Analogue Scale) at 6, 24 and 48 hours. The results will be recorded on a scale of 0 (minimal pain) to 10 (maximum pain).	Post surgery time 6, 24 and 48 hours.
Cumulative consumption of opioids	Compare the cumulative consumption of opioids (morphine equivalents).	From enrollment to the end of follow up 30 days
Nausea and vomiting	Compare the incidence of postoperative nausea and vomiting (PONV).	From enrollment to the end of follow up 30 days
Early ambulation	Compare the time in hours from end of surgery to early ambulation during hospitalization.	From end of surgery to ambulation
Oral tolerance	Compare the time in hours from end of surgery to oral tolerance during hospitalization.	From end of surgery to oral tolerance
Hospital stay	Compare the time of hospital stay in hours from hospitalization to discharged.	From enrrolment to end of hospital stay
Duration of surgery	Compare the duration of surgery in hours	From start surgery to end surgery
Perioperative complications	Compare perioperative complications according to the Clavien-Dindo classification. It grades complications from I (menor) to V (major), with suffix 'd' for permanent disability.	From enrollment to the end of follow up 30 days
Readmission or unscheduled consultations	Compare the rate of readmission or unscheduled consultations at 30 days.	From enrollment to the end of follow up 30 days
Postoperative recovery	Assess the quality of postoperative recovery using the QoR-15 questionnaire (Quality of Recovery-15). It consists of 15 items that assess pain, physical comfort, physical independence and emotional state, with a total score ranging from 0 to 150 (the higher the score, the better the recovery)	From enrollment to the end of follow up 30 days
Surgical procedure satisfaction	Compare the level of general satisfaction with the surgical procedure using a satisfaction questionnaire based on the Likert scale: Very dissatisfied, Dissatisfied, Neutral, Satisfied, Very satisfied.	From enrollment to the end of follow up 30 days
Predictive factors for better response to multimodal anesthesia	Determine predictive factors for better response to multimodal anesthesia (e. g.: age report in years, sex (male or female), the ASA (American Society of Anesthesiologists) classification (I-VI), weight and height will be combined to report BMI in kg/m^2, pathological history, nephrectomy, bleeding, perioperative complications).	From enrollment to the end of follow up 30 days

Collaborators and Investigators

• Sponsor: Fundacio Puigvert
• Investigators: Principal Investigator: DIANA VERNETTA, MD, FUNDACIO PUIGVERT IUNA

Study record dates

Study Major Dates

• Study Start (Estimated): May 2, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: April 10, 2026
• First Submitted That Met QC Criteria: April 23, 2026
• First Posted (Actual): April 30, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Robotic; Anesthesia; Nephrectomy; multimodal anesthesia; Multimodal; laparoscopic nephrectomy robotic; early hospital discharge
• Other Study ID Numbers: FP2026/01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The investigators and the sponsor will preserve the confidentiality of all patients participating in the clinical trial, in accordance with GCP, and the patient's identity will be kept confidential throughout the trial. Complete affiliation data and written consent will be kept in the investigator's file.

The personal data of the participants will be treated in accordance with Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on Data Protection (GDPR), and the corresponding Organic Law 3/2018, of 5 December, on the protection of personal data and the guarantee of digital rights. The data collected are only those data strictly necessary for the purposes of this research and will be used exclusively for this purpose.

• IPD Sharing Time Frame: IPD and supporting information will be available after publication (not end date)
• IPD Sharing Access Criteria: It will be published
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No