Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Tromso | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Placebo | Placebo Comparator | Local skin infiltration with lidocain 10 mg/ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to discharge from the post anesthesia care unit. | Minutes of stay in the post anesthesia care unit | 24 hrs |
Not provided
Not provided
Inclusion Criteria:
- Prostate cancer
Exclusion Criteria:
Males
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of North Norway | Tromsø | 9038 | Norway |
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D000775 | Anesthesia, Spinal |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D000813 | Anilides |
Not provided
Not provided
Double blinded placebo controlled study
Not provided
Not provided
Not provided
| Placebo | Drug | Local skin infiltration with lidocaine |
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000577 |
| Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |