NCT05579223

Intrathecal Hydromorphone for Postoperative Pain of Anorectal Surgery

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Pain
• Post Operative Pain
• Anorectal Disorder
• Analgesia

Interventions

Type	Name	Description
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
DRUG	Intrathecal Placebo Mono Injection	Placebo: 5% glucose injection. Administration: subarachnoid space mono bolus inject, 1.5ml, Speed ≤ 0.5 ml/s

Timeline

• Start date: 2022-10-17
• Primary completion: 2024-01-24
• Completion: 2024-01-27
• First posted: 2022-10-13
• Last updated: 2024-01-30

Locations

1 site across 1 country: China