Hemorrhoids, Postoperative Pain
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREPudendal nerve block
Patients who are randomized in the pudendal block group will receive bilateral pudendal nerve block with ropivacaine.
PROCEDUREPlacebo block
Patients who are randomized in the placebo group will receive bilateral pudendal block with normal saline.
Sponsors
Taipei Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients with symptomatic hemorrhoids (grade III and grade IV internal hemorrhoids, mixed hemorrhoids, and external hemorrhoids) * Age 20 to 65 years old * American Society of Anesthesiologists (ASA) classification I\ III * Receiving Ferguson hemorrhoidectomy under spinal anesthesia
Exclusion criteria
* Allergy to local anesthetics or analgesics used in this study * Drug abuse * Coagulopathy * An active infection at the injection site * Patient refusal * BMI ≥ 30 * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of recovery at 7 days | 7 days after hemorrhoidectomy | Quality of recovery-15 questionnaire measures the quality of recovery after surgery |
| Opioid consumption at 48 hours | 48 hours after hemorrhoidectomy | Morphine equivalent dose |
| Opioid consumption at 7 days | 7 days after hemorrhoidectomy | Morphine equivalent dose |
| Quality of recovery at baseline | Baseline | Quality of recovery-15 questionnaire measures the baseline quality of recovery |
| Quality of recovery at 24 hours | 24 hours after hemorrhoidectomy | Quality of recovery-15 questionnaire measures the quality of recovery after surgery |
| Quality of recovery at 48 hours | 48 hours after hemorrhoidectomy | Quality of recovery-15 questionnaire measures the quality of recovery after surgery |
| Pain score on the numeric rating scale (NRS) at baseline | Baseline | NRS ranges from 0 (no pain) to 10 (worst pain) |
| Postoperative pain score on the numeric rating scale (NRS) at 6 hours | 6 hours after hemorrhoidectomy | NRS ranges from 0 (no pain) to 10 (worst pain) |
| Postoperative pain score on the numeric rating scale (NRS) at 12 hours | 12 hours after hemorrhoidectomy | NRS ranges from 0 (no pain) to 10 (worst pain) |
| Postoperative pain score on the numeric rating scale (NRS) at 24 hours | 24 hours after hemorrhoidectomy | NRS ranges from 0 (no pain) to 10 (worst pain) |
| Postoperative pain score on the numeric rating scale (NRS) at 48 hours | 48 hours after hemorrhoidectomy | NRS ranges from 0 (no pain) to 10 (worst pain) |
| Postoperative pain score on the numeric rating scale (NRS) at 7 days | 7 days after hemorrhoidectomy | NRS ranges from 0 (no pain) to 10 (worst pain) |
| Opioid consumption at 6 hours | 6 hours after hemorrhoidectomy | Morphine equivalent dose |
| Opioid consumption at 12 hours | 12 hours after hemorrhoidectomy | Morphine equivalent dose |
| Opioid consumption at 24 hours | 24 hours after hemorrhoidectomy | Morphine equivalent dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to the first urination | Up to 48 hours after hemorrhoidectomy | Time after hemorrhoidectomy |
| Time to the first defecation | Up to 48 hours after hemorrhoidectomy | Time after hemorrhoidectomy |
| Patient satisfaction with pain control | 24 hours after hemorrhoidectomy | 0 (worst) to 10 (Best) |
| Postoperative complications | Up to 7 days after hemorrhoidectomy | Pudendal nerve block related complications |
| Time to first rescue analgesics | Up to 7 days after hemorrhoidectomy | Time after hemorrhoidectomy |
Countries
Taiwan
Contacts
Primary ContactYuan-Wen Lee, MD, PhD
Outcome results
None listed