A Phase 4 interventional study of Local Infiltration and Subarachnoidal block in Postoperative Pain, sponsored by Federal University of São Paulo. Completed. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-21.
Sponsored by Federal University of São Paulo · Phase 4, Interventional, and Treatment
Background and Objectives: Postoperative analgesia and early recovery are relevant for hospital discharge after hemorrhoidectomy. This study investigated the postoperative analgesic effect with local infiltration compared with spinal block.
Methods: This randomized study included 40 patients aged 18 to 60 years old. Local group (LG) received local infiltration under general anaesthesia; spinal group (SG) received a subarachnoid block. LG received general anaesthesia with propofol, atracurium and propofol infusion as well as a local infiltration of 20 ml 0.75% ropivacaine. SG received 2 ml of 0.5% hyperbaric bupivacaine. Analgesic supplementation was with 50µg of fentanyl for LG and 1% lidocaine for SG. There were assessed: postoperative pain intensity, sphincter relaxation, motor blockade of lower limbs, time to discharge, analgesic dose over 1 week and adverse effects.
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= 19 ) will be submitted to spinal block and group 2 (n=21) to local infiltration. The spinal block will be performed with 10 mg of 0.5% bupivacaine. The infiltration will be performed with 10 ml of 0.75% ropivacaine on each side.
Will be evaluated: intensity of pain on a numerical scale from 0 to 10 every 30 minutes, relaxation of the sphincter muscles, intensity of pain after the operation every 30 minutes until reached the criteria for discharge, motor blocked 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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 40 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Federal University of São Paulo is the lead sponsor of 427 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Induction of General Anesthesia with Propofol(2mg/Kg) and Atracurium(0,5mg/Kg) . Pulmonary ventilation with laryngeal mask and Propofol infusion ( 100mcg/Kg/min.) After , Infiltration of 0.75% ropivacaine (10 ml) each side block injection of local anesthetic at perianal. If necessary, fentanyl endovenous injection (50 mcg).
Procedure: Local Infiltration
Sedation with midazolam 2 mg. After , Spinal block with 10 mg of hyperbaric 0.5% bupivacaine. Injection of anesthetic at subarachnoidal space with Quincke needle 27G. If pain, local infiltration with lidocaine 1% (5 ml) in wound.
Procedure: Subarachnoidal block
Injection at perianal region with ropivacaine 0.75%(20ml)
Also known as: local anesthesia
Injection at subarachnoidal space with bupivacaine 0.5% ( 2ml)
Also known as: spinal anesthesia
Pain intensity
Numerical score
Time frame: 24 hours
Time to discharge
Time frame: 24 hours
Duration of motor blockade
Time frame: 24 hours
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Federal University of São Paulo