Spinal Anesthesia for Robotic Assisted Laparoscopic Prostatectomy

Last updated: February 28, 2025
Sponsor: University Hospital of North Norway
Overall Status: Active - Recruiting

Phase

4

Condition

Urologic Cancer

Prostate Cancer, Early, Recurrent

Prostate Cancer

Treatment

Placebo

Spinal Anesthesia with Bupivacaine

Clinical Study ID

NCT06860893
Prostate REK 866656
  • Ages 18-80
  • Male

Study Summary

We 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Prostate cancer

Exclusion

Exclusion Criteria:

  • Benign prostate disease

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 4
Study Start date:
February 23, 2025
Estimated Completion Date:
December 31, 2025

Study Description

Patients were allocated to either intrathecal injection of bupivacaine/morphine or a sham spinal procedure. All patients were placed in a sitting position and the skin over the lumbar region of the back was disinfected with chlorhexidine and draped sterile. In the intervention group the skin was infiltrated with 5 mL of lidocaine 10 mg/mL and a sterile 27-gauge pencil-point needle (Pajunk, GA, USA) was subsequently entered into the intrathecal space at the L2-3 or L3-4 interspace. 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. Patients in the placebo group received an identical treatment as the patients in the intervention group, except for the intrathecal injection. After the skin was infiltrated with 5 mL of lidocaine 10 mg/mL, the attending anesthesiologist pressed one finger at the skin and talked as if she was giving an intrathecal injection at the L3-4 interspace. All patients were treated by the same anesthesiologist (MA).

Connect with a study center

  • University Hospital of North Norway

    Tromso, 9038
    Norway

    Active - Recruiting

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