NCT06860893

Brief Summary

The investigators hypothesised that spinal anesthesia as an adjunct to general anesthesia would facilitate faster recovery and less pain in patients undergoing laparoscopic robotic prostatectomy. A double-blind placebo-controlled study was subsequently designed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

February 28, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 6, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2025

Completed
Last Updated

November 21, 2025

Status Verified

February 1, 2025

Enrollment Period

7 months

First QC Date

February 28, 2025

Last Update Submit

November 17, 2025

Conditions

Prostate Cancer Surgery

Keywords

Spinal anesthesiaRobotic assisted prostatectomyPostoperative pain

Outcome Measures

Primary Outcomes (1)

  • Time to discharge from the post anesthesia care unit.

    Minutes of stay in the post anesthesia care unit

    24 hrs

Study Arms (2)

Spinal anesthesia

ACTIVE COMPARATOR

After obtaining return of cerebrospinal fluid, hyperbaric bupivacaine 5 mg/mL 1,5 mL (7,5 mg) and morphine 200 µg/mL, 0.5 mL (100 µg) was injected intrathecally.

Drug: Spinal Anesthesia with Bupivacaine

Placebo

PLACEBO COMPARATOR

Local skin infiltration with lidocain 10 mg/ml

Drug: Placebo

Interventions

Spinal Anesthesia with BupivacaineDRUG

After obtaining return of cerebrospinal fluid, hyperbaric bupivacaine 5 mg/mL 1,5 mL (7,5 mg) and morphine 200 µg/mL, 0.5 mL (100 µg) was injected intrathecally.

Spinal anesthesia
PlaceboDRUG

Local skin infiltration with lidocaine

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMales
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Prostate cancer

You may not qualify if:

  • Benign prostate disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of North Norway

Tromsø, 9038, Norway

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, SpinalBupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double blinded placebo controlled study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2025

First Posted

March 6, 2025

Study Start

February 28, 2025

Primary Completion

September 20, 2025

Study Completion

September 20, 2025

Last Updated

November 21, 2025

Record last verified: 2025-02

Locations

NO(1)