Intrathecal Hydromorphone for Postoperative Pain of Anorectal Surgery (IMPAS)

Shanghai Jiao Tong University

Status and phase: Completed; Phase 2

Conditions: Anorectal Disorder; Analgesia; Acute Pain; Post Operative Pain

Treatments: Drug: Intrathecal Hydromorphone Mono Injection; Drug: Intrathecal Placebo Mono Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05579223

XH-22-005

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

Intrathecal Hydromorphone Group (ITHM)

Experimental group

Description:

Dosage Form: Hydromorphone Hydrochloride Injection 2mg:2ml. Dosage: 75 μg+ 5% glucose injection diluted to 1.5ml. Frequency and Duration: i.t., st

Treatment:

Drug: Intrathecal Hydromorphone Mono Injection

Intrathecal Placebo Group (ITPO)

Placebo Comparator group

Description:

Dosage Form: 5% glucose injection, 100ml/Package. Dosage: 1.5ml. Frequency and Duration: i.t., st

Treatment:

Drug: Intrathecal Placebo Mono Injection