Intrathecal Hydromorphone for Postoperative Pain of Anorectal Surgery

Analgesia Clinical Trial

— IMPAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05579223
• Other study ID #: XH-22-005
• Status: Completed
• Phase: Phase 2
• Start date: October 17, 2022
• Est. completion date: January 27, 2024

Study information

• Verified date: November 2023
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 27, 2024
• Est. primary completion date: January 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Analgesia
• Anorectal Disorder
• Pain, Postoperative
• Post Operative Pain
• Rectal Diseases

Intervention

Drug:
• Intrathecal 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
• Intrathecal Placebo Mono Injection
Placebo: 5% glucose injection. Administration: subarachnoid space mono bolus inject, 1.5ml, Speed = 0.5 ml/s

Locations

Country	Name	City	State
China	Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Quality of Recovery Scale (QoR)	40-item quality of recovery score, QoR-40	At 12, 24 and 36 hours post spinal administration.