Spinal Anesthesia for Robotic Assisted Laparoscopic Prostatectomy

Phase 4

Recruiting

• Conditions: Prostate Cancer Surgery
• Interventions: Drug: Spinal Anesthesia with Bupivacaine; Drug: Placebo

• Registration Number: NCT06860893
• Lead Sponsor: University Hospital of North Norway

Brief 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.

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).

Study Timeline

• Status Verified: 2025-02
• Study Start: 2025-02-23
• Study First Submitted: 2025-02-28
• Study First Submitted QC: 2025-02-28
• Last Update Submitted: 2025-02-28
• Study First Posted: 2025-03-06
• Last Update Posted: 2025-03-06
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• Prostate cancer

Exclusion Criteria

• Benign prostate disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spinal anesthesia	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	Local skin infiltration with lidocain 10 mg/ml

Primary Outcome Measures

Name	Time	Method
Numeric rating scale	24 hrs	PAin

Trial Locations

Locations (1)

University Hospital of North Norway; 🇳🇴 Tromso, Norway