Acute PainPhase 2IMPASNCT05579223
Intrathecal Hydromorphone for Postoperative Pain of Anorectal Surgery
A Phase 2 study testing Intrathecal Hydromorphone Mono Injection in people with Acute Pain and Post Operative Pain, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Pain, Post Operative Pain, Anorectal Disorder
- What is being tested?
- Intrathecal Hydromorphone Mono Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 17 Oct 2022to 27 Jan 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 20092
About this study
Official title: Intrathecal Hydromorphone for Postoperative Pain of Anorectal Surgery: A Randomized, Double-blind, Parallel, Placebo-controlled Trial
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.
- Conditions
- Acute Pain, Post Operative Pain, Anorectal Disorder, Analgesia
- Being tested
- Intrathecal Hydromorphone Mono Injection, Intrathecal Placebo Mono Injection
- Keywords
- hydromorphone, intrathecal opioid, post operative pain, anorectal surgery, placebo
- Medical subject headings
- Acute Pain, Pain, Postoperative, Rectal Diseases, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal Hydromorphone Mono InjectionDrug
Also called ITHM
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
Intrathecal Placebo Mono InjectionDrug
Also called ITPO
Placebo: 5% glucose injection. Administration: subarachnoid space mono bolus inject, 1.5ml, Speed ≤ 0.5 ml/s
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Intrathecal Hydromorphone Mono Injection |
| Intrathecal Placebo Group (ITPO) | Placebo comparator | Dosage Form: 5% glucose injection, 100ml/Package. Dosage: 1.5ml. Frequency and Duration: i.t., st Receives: Drug: Intrathecal Placebo Mono Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale Pain Scores (NRS score for pain)
NRS for pain (0-10) with movement 12 hours after spinal administration
Measured: 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 outcomes (6)
NRS score at rest/with movement
NRS score for pain (0-10) with movement, and at rest.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: At 12, 24 and 36 hours post spinal administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start17 Oct 2022
- Primary completion24 Jan 2024
- Study completion27 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiangtao Xu, M.D., Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579223
- Sponsor's protocol ID
- XH-22-005
- Acronym
- IMPAS
- Status last verified
- Nov 2023
- First submitted
- 28 Sep 2022
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrathecal Hydromorphone for Postoperative Pain of Anorectal Surgery: A Randomized, Double-blind, Parallel, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05579223
- Acronym / sponsor ID
- IMPAS / XH-22-005
- Conditions
- Acute Pain, Post Operative Pain, Anorectal Disorder, Analgesia
- Keywords
- hydromorphone, intrathecal opioid, post operative pain, anorectal surgery, placebo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 24 Jan 2024 (actual)
- Study completion
- 27 Jan 2024 (actual)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrathecal Hydromorphone Group (ITHM) | Experimental | Drug: Intrathecal Hydromorphone Mono InjectionDosage 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 | Drug: Intrathecal Placebo Mono InjectionDosage Form: 5% glucose injection, 100ml/Package. Dosage: 1.5ml. Frequency and Duration: i.t., st |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrathecal Hydromorphone Mono InjectionAlso: ITHMExperimental Drug: Hydromorphone Hydrochloride Injection. Administration: subarachnoid space mono bolus inject, + 5% glucose injection diluted to 75 μg:1.5ml, Speed ≤ 0.5 ml/s | Drug | Intrathecal Hydromorphone Group (ITHM) |
| Intrathecal Placebo Mono InjectionAlso: ITPOPlacebo: 5% glucose injection. Administration: subarachnoid space mono bolus inject, 1.5ml, Speed ≤ 0.5 ml/s | Drug | Intrathecal Placebo Group (ITPO) |
Primary outcome
Numerical Rating Scale Pain Scores (NRS score for pain)
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 for pain (0-10) with movement 12 hours after spinal administration
6 secondary outcomes
NRS score at rest/with movement
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
Time frame: At 12 hours after spinal administration.
Severity and incidence of any opioid-related complication at each time point
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
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 frame: Data will be collected by patient interview at 12 hours after spinal administration.
Quality of Recovery Scale (QoR)
Time frame: At 12, 24 and 36 hours post spinal administration.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiangtao Xu, M.D. principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intrathecal Hydromorphone Mono Injection in people with Acute Pain and Post Operative Pain, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale Pain Scores (NRS score for pain) (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.