Spinal Anesthesia for Robotic Assisted Laparoscopic Prostatectomy

University Hospital of North Norway

Status and phase: Enrolling; Phase 4

Conditions: Prostate Cancer Surgery

Treatments: Drug: Placebo; Drug: Spinal Anesthesia with Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT06860893

Prostate REK 866656

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Prostate cancer

Exclusion criteria

• Benign prostate disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Spinal anesthesia

Active Comparator group

Description:

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.

Treatment:

Drug: Spinal Anesthesia with Bupivacaine

Placebo

Placebo Comparator group

Description:

Local skin infiltration with lidocain 10 mg/ml

Treatment:

Drug: Placebo