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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
There will be compared the postoperative analgesic effect of infiltration or spinal block for hemorrhoidectomy
This is a prospective, randomized study, including 40 patients between 18 and 60 years, of both genders, ASA 1 or 2.
Patients in group 1 (n = 20) will be submitted to spinal block and group 2 (n = 20) to infiltration. The spinal block will be performed with 10 mg of 0.5% bupivacaine. The infiltration will be performed with 10 ml of 0.5% bupivacaine with epinephrine on each side.
Will be evaluated: intensity of pain on a numerical scale from 0 to 10 every 15 minutes, relaxation of the sphincter muscles, intensity of pain after the operation every 30 minutes until reached the criteria for discharge, muscle strength of the lower limbs every 30 minutes, BP, HR, SO2, FR, other items that determine the conditions of discharge (urine output, nausea and vomiting), time to hospital discharge, and duration of analgesia. Adverse effects and complications will be noted.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infiltration, analgesic effect | Active Comparator | 10ml 0.5% bupivacaine each side Block Injection of local anesthetic at pudendal nerve |
|
| Spinal block | Active Comparator | 10 mg of hyperbaric 0.5% bupivacaine Injection of anesthetic at subarachnoidal space |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infiltration | Procedure | injection of local anesthetic, associated with general anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | Numerical score | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to discharge | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of motor blockade | 24 hours |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rioko K Sakata, PhD | Universidade Federal de São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Federal de São Paulo | São Paulo | São Paulo | 04044020 | Brazil |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006484 | Hemorrhoids |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000772 | Anesthesia, Local |
| D000775 | Anesthesia, Spinal |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D000813 | Anilides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Spinal block | Procedure | injection of anesthetic |
|
|
| Bupivacaine | Drug | 10ml 0.5% bupivacaine. |
|
|
| 10 mg of hyperbaric 0.5% bupivacaine | Drug | Spinal punction and injection of local anesthetic |
|
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000577 |
| Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |