Intrathecal Hydromorphone for Postoperative Pain of Anorectal Surgery

Phase 2

Completed

• Conditions: Post Operative Pain; Analgesia; Anorectal Disorder; Acute Pain
• Interventions: Drug: Intrathecal Hydromorphone Mono Injection; Drug: Intrathecal Placebo Mono Injection

• Registration Number: NCT05579223
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-28
• Study First Submitted QC: 2022-10-11
• Study First Posted: 2022-10-13
• Study Start: 2022-10-17
• Status Verified: 2023-11
• Primary Completion: 2024-01-24
• Study Completion: 2024-01-27
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

  3. Severe infection,

  4. Respiratory insufficiency,

  5. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intrathecal Hydromorphone Group (ITHM)	Intrathecal Hydromorphone Mono Injection	Dosage 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)	Intrathecal Placebo Mono Injection	Dosage Form: 5% glucose injection, 100ml/Package. Dosage: 1.5ml. Frequency and Duration: i.t., st

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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.
Quality of Recovery Scale (QoR)	At 12, 24 and 36 hours post spinal administration.	40-item quality of recovery score, QoR-40
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

Trial Locations

Locations (1)

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China