A Phase 2 interventional study of Intrathecal Hydromorphone Mono Injection and Intrathecal Placebo Mono Injection in Acute Pain, Post Operative Pain and Anorectal Disorder, sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-01-30.
Sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Phase 2, Interventional, and Treatment
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.
1,073 studies on the registry are indexed under Acute Pain; 166 are open to participants now.
This study's enrollment of 150 is above the median of 86 across 902 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →Xinhua Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 225 studies on the registry; 55 are open to participants now.
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Exclusion Criteria:
Complex co-morbidities, including
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Dosage Form: 5% glucose injection, 100ml/Package. Dosage: 1.5ml. Frequency and Duration: i.t., st
Drug: Intrathecal Placebo 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
Also known as: ITHM
Placebo: 5% glucose injection. Administration: subarachnoid space mono bolus inject, 1.5ml, Speed ≤ 0.5 ml/s
Also known as: ITPO
Numerical Rating Scale Pain Scores (NRS score for pain)
NRS for pain (0-10) with movement 12 hours after spinal administration
Time frame: 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 score at rest/with movement
NRS score for pain (0-10) with movement, and at rest.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: At 12, 24 and 36 hours post spinal administration.
Plan to share: No — 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.
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine →