Acute Pain, Analgesia, Anorectal Disorder, Post Operative Pain
Conditions
Keywords
hydromorphone, intrathecal opioid, post operative pain, anorectal surgery, placebo
Brief summary
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.
Interventions
DRUGIntrathecal Hydromorphone Mono Injection
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
DRUGIntrathecal Placebo Mono Injection
Placebo: 5% glucose injection. Administration: subarachnoid space mono bolus inject, 1.5ml, Speed ≤ 0.5 ml/s
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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 1. Severe infection, 2. Respiratory insufficiency, 3. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Rating Scale Pain Scores (NRS score for pain) | 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. | NRS for pain (0-10) with movement 12 hours after spinal administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Highest pain NRS (0-10) in previous 12 hours | At 12 hours after spinal administration. | NRS score for pain (0-10) with movement or at rest and the time. |
| Severity and incidence of any opioid-related complication at each time point | All data will be collected by patient interview at 1, 3, 6, 12, 24 and 36 hours after spinal administration. | Including: nausea, vomiting, constipation, diarrhea, itching, dry mouth, dizziness, numbness, depression, anxiety, fever, skin rash, urinary retention, Etc. |
| NRS score at rest/with movement | 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. | NRS score for pain (0-10) with movement, and at rest. |
| Recovery of lower extremity strength. | Data will be collected by patient interview at 12 hours after spinal administration. | Time required to the recovery of casual movement of the lower extremities |
| Quality of Recovery Scale (QoR) | At 12, 24 and 36 hours post spinal administration. | 40-item quality of recovery score, QoR-40 |
| Total non-opioid analgesic consumption | All data will be collected by patient interview at 12, 24 and 36 hours after spinal administration. | Total non-opioid analgesic consumption at 12, 24 and 36 hours after spinal administration, mainly intravenous parecoxib/ketorolac/flurbiprofen injection dosage. |
Countries
China
Outcome results
None listed