Spinal Anesthesia for Robotic Assisted Laparoscopic Prostatectomy

NCT06860893 — Phase 4, Completed, 30 participants, University Hospital of North Norway

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Spinal Anesthesia as an Adjunct to General Anesthesia for Robotic Assisted Laparoscopic Prostatectomy - a Randomised Placebo- Controlled Trial

Registry	NCT06860893
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	30 (Actual)
Sponsor	University Hospital of North Norway (Other); collaborators: University of Tromso
Conditions	Prostate Cancer Surgery
Interventions	Spinal Anesthesia with Bupivacaine, Placebo (Drug)
Dates	start 2025-02-28, primary completion 2025-09-20, completion 2025-09-20, first posted 2025-03-06, last updated 2025-11-21
Locations	1 site in Norway

-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.

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+Detailed 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).

+Arms and interventions

Arm	Type	Interventions	Description
Spinal anesthesia	Active comparator	Drug: Spinal Anesthesia with Bupivacaine	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.
Placebo	Placebo comparator	Drug: Placebo	Local skin infiltration with lidocain 10 mg/ml

Spinal Anesthesia with Bupivacaine (Drug): 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.
Placebo (Drug): Local skin infiltration with lidocaine

+Outcome measures

Primary outcomes

Time to discharge from the post anesthesia care unit. [24 hrs]: Minutes of stay in the post anesthesia care unit

+Eligibility

Sex: Male, ages: 18 Years to 80 Years

Inclusion Criteria:

\- Prostate cancer

Exclusion Criteria:

* Benign prostate disease

+Locations (1)

Facility	City	Country	Status
University Hospital of North Norway	Tromsø	Norway