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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pudendal block group | Experimental | Receiving bilateral pudendal nerve block with 0.5% ropivacaine (10 ml each side) |
|
| Placebo group | Placebo Comparator | Receiving bilateral pudendal nerve block with normal saline (10 ml each side) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pudendal nerve block | Procedure | Patients who are randomized in the pudendal block group will receive bilateral pudendal nerve block with ropivacaine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain score on the numeric rating scale (NRS) at baseline | NRS ranges from 0 (no pain) to 10 (worst pain) | Baseline |
| Postoperative pain score on the numeric rating scale (NRS) at 6 hours | NRS ranges from 0 (no pain) to 10 (worst pain) | 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) | 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) | 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) | 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) | 7 days after hemorrhoidectomy |
| Opioid consumption at 6 hours | Morphine equivalent dose | 6 hours after hemorrhoidectomy |
| Opioid consumption at 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first rescue analgesics | Time after hemorrhoidectomy | Up to 7 days after hemorrhoidectomy |
| Time to the first urination | Time after hemorrhoidectomy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuan-Wen Lee, MD, PhD | Contact | +886-2-27372181 | 8310 | m102093020@tmu.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Yuan-Wen Lee, MD, PhD | Taipei Medical University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Medical University Hospital | Recruiting | Taipei | Taiwan |
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| ID | Term |
|---|---|
| D006484 | Hemorrhoids |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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Patients are randomly allocated into pudendal block group or placebo group. Pudendal block group: Patients will receive pudendal nerve block with ropivacaine.
Placebo group: Patients will receive pudendal nerve block with normal saline.
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| Placebo block | Procedure | Patients who are randomized in the placebo group will receive bilateral pudendal block with normal saline. |
|
Morphine equivalent dose
| 12 hours after hemorrhoidectomy |
| Opioid consumption at 24 hours | Morphine equivalent dose | 24 hours after hemorrhoidectomy |
| Opioid consumption at 48 hours | Morphine equivalent dose | 48 hours after hemorrhoidectomy |
| Opioid consumption at 7 days | Morphine equivalent dose | 7 days after hemorrhoidectomy |
| Quality of recovery at baseline | Quality of recovery-15 questionnaire measures the baseline quality of recovery | Baseline |
| Quality of recovery at 24 hours | Quality of recovery-15 questionnaire measures the quality of recovery after surgery | 24 hours after hemorrhoidectomy |
| Quality of recovery at 48 hours | Quality of recovery-15 questionnaire measures the quality of recovery after surgery | 48 hours after hemorrhoidectomy |
| Quality of recovery at 7 days | Quality of recovery-15 questionnaire measures the quality of recovery after surgery | 7 days after hemorrhoidectomy |
| Up to 48 hours after hemorrhoidectomy |
| Time to the first defecation | Time after hemorrhoidectomy | Up to 48 hours after hemorrhoidectomy |
| Patient satisfaction with pain control | 0 (worst) to 10 (Best) | 24 hours after hemorrhoidectomy |
| Postoperative complications | Pudendal nerve block related complications | Up to 7 days after hemorrhoidectomy |
| 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 |