The goal of this clinical trial is to investigate the effects of ultrasound-guided pudendal nerve block on postoperative pain, opioid consumption, and quality of recovery in patients receiving Ferguson hemorrhoidectomy.
Patients who have symptomatic hemorrhoids undergoing Ferguson hemorrhoidectomy under spinal anesthesia will be randomized to receive bilateral ultrasound-guided pudendal nerve block with 0.5% ropivacaine or normal saline immediately after surgery. In addition, intravenous patient controlled analgesia, NSAIDs, and acetaminophen will be used in all participants for postoperative pain control. Postoperative pain on numerical rating scale (NRS), opioid consumption, quality of recovery (QOR-15), patient's satisfaction, and complications will be recorded at 6, 12, 24, 48 hours and 7 days after surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Patients who are randomized in the pudendal block group will receive bilateral pudendal nerve block with ropivacaine.
Patients who are randomized in the placebo group will receive bilateral pudendal block with normal saline.
Taipei Medical University Hospital
Taipei, Taiwan
RECRUITINGPain score on the numeric rating scale (NRS) at baseline
NRS ranges from 0 (no pain) to 10 (worst pain)
Time frame: Baseline
Postoperative pain score on the numeric rating scale (NRS) at 6 hours
NRS ranges from 0 (no pain) to 10 (worst pain)
Time frame: 6 hours after hemorrhoidectomy
Postoperative pain score on the numeric rating scale (NRS) at 12 hours
NRS ranges from 0 (no pain) to 10 (worst pain)
Time frame: 12 hours after hemorrhoidectomy
Postoperative pain score on the numeric rating scale (NRS) at 24 hours
NRS ranges from 0 (no pain) to 10 (worst pain)
Time frame: 24 hours after hemorrhoidectomy
Postoperative pain score on the numeric rating scale (NRS) at 48 hours
NRS ranges from 0 (no pain) to 10 (worst pain)
Time frame: 48 hours after hemorrhoidectomy
Postoperative pain score on the numeric rating scale (NRS) at 7 days
NRS ranges from 0 (no pain) to 10 (worst pain)
Time frame: 7 days after hemorrhoidectomy
Opioid consumption at 6 hours
Morphine equivalent dose
Time frame: 6 hours after hemorrhoidectomy
Opioid consumption at 12 hours
Morphine equivalent dose
Time frame: 12 hours after hemorrhoidectomy
Opioid consumption at 24 hours
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Morphine equivalent dose
Time frame: 24 hours after hemorrhoidectomy
Opioid consumption at 48 hours
Morphine equivalent dose
Time frame: 48 hours after hemorrhoidectomy
Opioid consumption at 7 days
Morphine equivalent dose
Time frame: 7 days after hemorrhoidectomy
Quality of recovery at baseline
Quality of recovery-15 questionnaire measures the baseline quality of recovery
Time frame: Baseline
Quality of recovery at 24 hours
Quality of recovery-15 questionnaire measures the quality of recovery after surgery
Time frame: 24 hours after hemorrhoidectomy
Quality of recovery at 48 hours
Quality of recovery-15 questionnaire measures the quality of recovery after surgery
Time frame: 48 hours after hemorrhoidectomy
Quality of recovery at 7 days
Quality of recovery-15 questionnaire measures the quality of recovery after surgery
Time frame: 7 days after hemorrhoidectomy
Time to first rescue analgesics
Time after hemorrhoidectomy
Time frame: Up to 7 days after hemorrhoidectomy
Time to the first urination
Time after hemorrhoidectomy
Time frame: Up to 48 hours after hemorrhoidectomy
Time to the first defecation
Time after hemorrhoidectomy
Time frame: Up to 48 hours after hemorrhoidectomy
Patient satisfaction with pain control
0 (worst) to 10 (Best)
Time frame: 24 hours after hemorrhoidectomy
Postoperative complications
Pudendal nerve block related complications
Time frame: Up to 7 days after hemorrhoidectomy