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Anorectal problems, such as hemorrhoids, fistula, fissures, Etc., often require surgical treatment. Patients often have postoperative pain after these surgeries, which increases discomfort and hospital length of stay. The efficacy of oral non-opioids in the treatment of such pain is poor. Hydromorphone is an opioid analgesic commonly used orally or intravenously for postoperative pain management. We designed this trial to investigate the efficacy and safety of intrathecal (delivery directly to the spinal cord during spinal anesthesia) single dose hydromorphone versus intrathecal placebo in treating postoperative pain among human subjects after anorectal surgery, but also the recovery of postoperative motor capacity in these human subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intrathecal Hydromorphone Group (ITHM) | Experimental | Dosage Form: Hydromorphone Hydrochloride Injection 2mg:2ml. Dosage: 75 μg+ 5% glucose injection diluted to 1.5ml. Frequency and Duration: i.t., st |
|
| Intrathecal Placebo Group (ITPO) | Placebo Comparator | Dosage Form: 5% glucose injection, 100ml/Package. Dosage: 1.5ml. Frequency and Duration: i.t., st |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrathecal Hydromorphone Mono Injection | Drug | Experimental Drug: Hydromorphone Hydrochloride Injection. Administration: subarachnoid space mono bolus inject, + 5% glucose injection diluted to 75 μg:1.5ml, Speed ≤ 0.5 ml/s |
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Rating Scale Pain Scores (NRS score for pain) | NRS for pain (0-10) with movement 12 hours after spinal administration | Time of spinal injection finished will be noted as time: "0". NRS, with movement 12 hours, will be collected by patient interview at 12 hours after spinal administration. |
| Measure | Description | Time Frame |
|---|---|---|
| NRS score at rest/with movement | NRS score for pain (0-10) with movement, and at rest. | Time of spinal injection finished will be noted as time: "0". NRS, with movement or at rest, will be collected by patient interview at 1, 3, 6, 12, 24 and 36 hours after spinal administration. |
| Highest pain NRS (0-10) in previous 12 hours |
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Inclusion Criteria:
Exclusion Criteria:
1. Any contraindications to spinal anesthesia and intrathecal analgesia.
2. Complex co-morbidities, including
3. Chronic pain syndrome or current opioid use >10mg oral morphine equivalents/day
4. Allergy or intolerance to hydromorphone, NSAIDs and Cox-2 selective Inhibitor
5. Clinical diagnosis of obstructive sleep apnea syndrome(OSAS)
6. History of drug abuse
7. Women who are breastfeeding or pregnant
8. Participation in other clinical trials within three months
9. Already participated in this study once
10. Not considered suitable for the clinical trial by the investigators
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| Name | Affiliation | Role |
|---|---|---|
| Jiangtao Xu, M.D. | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 20092 | China |
This trial's study protocol, case report forms, Etc., is written in Chinese as the primary language. The Ethics Committee and the Human Genetic Resources Office have approved this trial. After completing the last follow-up, we will upload the translated versions as soon as possible.
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D010149 | Pain, Postoperative |
| D012002 | Rectal Diseases |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Intrathecal Placebo Mono Injection | Drug | Placebo: 5% glucose injection. Administration: subarachnoid space mono bolus inject, 1.5ml, Speed ≤ 0.5 ml/s |
|
|
NRS score for pain (0-10) with movement or at rest and the time. |
| At 12 hours after spinal administration. |
| Severity and incidence of any opioid-related complication at each time point | Including: nausea, vomiting, constipation, diarrhea, itching, dry mouth, dizziness, numbness, depression, anxiety, fever, skin rash, urinary retention, Etc. | All data will be collected by patient interview at 1, 3, 6, 12, 24 and 36 hours after spinal administration. |
| Total non-opioid analgesic consumption | Total non-opioid analgesic consumption at 12, 24 and 36 hours after spinal administration, mainly intravenous parecoxib/ketorolac/flurbiprofen injection dosage. | All data will be collected by patient interview at 12, 24 and 36 hours after spinal administration. |
| Recovery of lower extremity strength. | Time required to the recovery of casual movement of the lower extremities | Data will be collected by patient interview at 12 hours after spinal administration. |
| Quality of Recovery Scale (QoR) | 40-item quality of recovery score, QoR-40 | At 12, 24 and 36 hours post spinal administration. |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |