Intrathecal Hydromorphone for Postoperative Pain of Anorectal Surgery (IMPAS)

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

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.

Study Overview

• Status: Completed
• Conditions: Analgesia; Acute Pain; Post Operative Pain; Anorectal Disorder
• Intervention / Treatment: Drug: Intrathecal Hydromorphone Mono Injection; Drug: Intrathecal Placebo Mono Injection

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 20092
      • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

  1. Severe infection,
  2. Respiratory insufficiency,
  3. 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intrathecal Hydromorphone Group (ITHM); 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; 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
Placebo Comparator: Intrathecal Placebo Group (ITPO); Dosage Form: 5% glucose injection, 100ml/Package. Dosage: 1.5ml. Frequency and Duration: i.t., st	Drug: Intrathecal Placebo Mono Injection; Placebo: 5% glucose injection. Administration: subarachnoid space mono bolus inject, 1.5ml, Speed ≤ 0.5 ml/s; Other Names: ITPO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS score at rest/with movement	NRS score for pain (0-10) with movement, and at rest.	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	NRS score for pain (0-10) with movement or at rest and the time.	At 12 hours after spinal administration.
Severity and incidence of any opioid-related complication at each time point	Including: nausea, vomiting, constipation, diarrhea, itching, dry mouth, dizziness, numbness, depression, anxiety, fever, skin rash, urinary retention, Etc.	All data will be collected by patient interview at 1, 3, 6, 12, 24 and 36 hours after spinal administration.
Recovery of lower extremity strength.	Time required to the recovery of casual movement of the lower extremities	Data will be collected by patient interview at 12 hours after spinal administration.
Quality of Recovery Scale (QoR)	40-item quality of recovery score, QoR-40	At 12, 24 and 36 hours post spinal administration.
Total non-opioid analgesic consumption	Total non-opioid analgesic consumption at 12, 24 and 36 hours after spinal administration, mainly intravenous parecoxib/ketorolac/flurbiprofen injection dosage.	All data will be collected by patient interview at 12, 24 and 36 hours after spinal administration.

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Jiangtao Xu, M.D., Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2022
• Primary Completion (Actual): January 24, 2024
• Study Completion (Actual): January 27, 2024

Study Registration Dates

• First Submitted: September 28, 2022
• First Submitted That Met QC Criteria: October 11, 2022
• First Posted (Actual): October 13, 2022

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: placebo; post operative pain; hydromorphone; anorectal surgery; intrathecal opioid
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Gastrointestinal Diseases; Intestinal Diseases; Pain, Postoperative; Acute Pain; Rectal Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Hydromorphone
• Other Study ID Numbers: XH-22-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This trial's study protocol, case report forms, Etc., is written in Chinese as the primary language. The Ethics Committee and the Human Genetic Resources Office have approved this trial. After completing the last follow-up, we will upload the translated versions as soon as possible.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No