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NCT Number: NCT05579223

Intrathecal Hydromorphone for Postoperative Pain of Anorectal Surgery

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.

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Key information

Conditions

Acute Pain Agnosia Analgesia Anorectal Disorder Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Post Operative Pain Postoperative Complications Rectal Diseases Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 20092, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Severe infection,
  • Respiratory insufficiency,
  • 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

Treatment and study plan

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

Other names: ITHM

Intrathecal Placebo Mono Injection

Drug

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

Other names: ITPO

Primary outcomes

  1. Numerical Rating Scale Pain Scores (NRS score for pain)

    Time frame: 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 outcomes

  1. NRS score at rest/with movement

    Time frame: 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.

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

    Time frame: At 12 hours after spinal administration.

    NRS score for pain (0-10) with movement or at rest and the time.

  3. Severity and incidence of any opioid-related complication at each time point

    Time frame: 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.

  4. Total non-opioid analgesic consumption

    Time frame: 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.

  5. Recovery of lower extremity strength.

    Time frame: 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

  6. Quality of Recovery Scale (QoR)

    Time frame: At 12, 24 and 36 hours post spinal administration.

    40-item quality of recovery score, QoR-40

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Acronym: IMPAS

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 13, 2022
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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