Intrathecal Hydromorphone for Postoperative Pain of Anorectal Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Intrathecal Hydromorphone for Postoperative Pain of Anorectal Surgery: A Randomized, Double-blind, Parallel, Placebo-controlled Trial

Conditions
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Acute Pain, Post Operative Pain, Anorectal Disorder, Analgesia

Intervention / Treatment
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* Drug: Intrathecal Hydromorphone Mono Injection
* Drug: Intrathecal Placebo Mono Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Clinical Diagnosis of anorectal disease, ready to undergo elective surgery 2. American Society of Anesthesiologists(ASA) physical status I-II 3. Desire to have a spinal anesthesia 4. Must be able to follow the medication dose and visit schedule Exclusion Criteria: 1. Any contraindications to spinal anesthesia and intrathecal analgesia. 2. Complex co-morbidities, including Severe infection, Respiratory insufficiency, History of psychiatric or neurological disorders and other cognitive impairments 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intrathecal Hydromorphone Group (ITHM)<br>Dosage Form: Hydromorphone Hydrochloride Injection 2mg:2ml. Dosage: 75 μg+ 5% glucose injection diluted to 1.5ml. Frequency and Duration: i.t., st | Drug: Intrathecal Hydromorphone Mono Injection<br>* 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<br>* Other names: ITHM;|
| Placebo Comparator: Intrathecal Placebo Group (ITPO)<br>Dosage Form: 5% glucose injection, 100ml/Package. Dosage: 1.5ml. Frequency and Duration: i.t., st | Drug: Intrathecal Placebo Mono Injection<br>* Placebo: 5% glucose injection. Administration: subarachnoid space mono bolus inject, 1.5ml, Speed ≤ 0.5 ml/s<br>* Other names: ITPO;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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placebo, hydromorphone, intrathecal opioid, post operative pain, anorectal surgery