Intrathecal Hydromorphone for Postoperative Pain of Anorectal Surgery

NCT05579223 | Completed Phase 2 DMC

• 1 other identifier: XH-22-005
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pain; Post Operative Pain; Anorectal Disorder; Analgesia

Keywords

hydromorphone; intrathecal opioid; post operative pain; anorectal surgery; placebo

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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.

• Highest pain NRS (0-10) in previous 12 hours

  At 12 hours after spinal administration.

• 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.

• Total non-opioid analgesic consumption

  All data will be collected by patient interview at 12, 24 and 36 hours after spinal administration.

• Recovery of lower extremity strength.

  Data will be collected by patient interview at 12 hours after spinal administration.

Study Arms (2)

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

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

Drug: Intrathecal Placebo Mono Injection

Interventions

Intrathecal Hydromorphone Mono Injection DRUG

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

Also known as: ITHM

Intrathecal Hydromorphone Group (ITHM)

Intrathecal Placebo Mono Injection DRUG

Placebo: 5% glucose injection. Administration: subarachnoid space mono bolus inject, 1.5ml, Speed ≤ 0.5 ml/s

Also known as: ITPO

Intrathecal Placebo Group (ITPO)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Clinical Diagnosis of anorectal disease, ready to undergo elective surgery
• \. American Society of Anesthesiologists(ASA) physical status I-II
• \. Desire to have a spinal anesthesia
• \. Must be able to follow the medication dose and visit schedule

You may not qualify if:

• \. Any contraindications to spinal anesthesia and intrathecal analgesia.
• \. Complex co-morbidities, including
• Severe infection,
• Respiratory insufficiency,
• History of psychiatric or neurological disorders and other cognitive impairments
• \. Chronic pain syndrome or current opioid use \>10mg oral morphine equivalents/day
• \. Allergy or intolerance to hydromorphone, NSAIDs and Cox-2 selective Inhibitor
• \. Clinical diagnosis of obstructive sleep apnea syndrome(OSAS)
• \. History of drug abuse
• \. Women who are breastfeeding or pregnant
• \. Participation in other clinical trials within three months
• \. Already participated in this study once
• \. Not considered suitable for the clinical trial by the investigators

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 20092, China

Location

MeSH Terms

Conditions

Acute Pain; Pain, Postoperative; Rectal Diseases; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Jiangtao Xu, M.D.

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 13, 2022
• Study Start: October 17, 2022
• Primary Completion: January 24, 2024
• Study Completion: January 27, 2024
• Last Updated: January 30, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)