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Intrathecal Hydromorphone for Postoperative Pain of Anorectal Surgery (IMPAS)

Primary Purpose

Acute Pain, Post Operative Pain, Anorectal Disorder

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Intrathecal Hydromorphone Mono Injection
Intrathecal Placebo Mono Injection
Sponsored by
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain focused on measuring hydromorphone, intrathecal opioid, post operative pain, anorectal surgery, placebo

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

    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, Parecoxib
  • 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

Sites / Locations

  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intrathecal Hydromorphone Group (ITHM)

Intrathecal Placebo Group (ITPO)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Numerical Rating Scale Pain Scores (NRS score for pain)
NRS for pain (0-10) with movement 12 hours after spinal administration

Secondary Outcome Measures

NRS score at rest/with movement
NRS score for pain (0-10) with movement, and at rest.
Highest pain NRS (0-10) in previous 12 hours
NRS score for pain (0-10) with movement or at rest and the time.
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.
Total non-opioid analgesic consumption
Total non-opioid analgesic consumption at 12, 24 and 36 hours after spinal administration, mainly intravenous parecoxib injection dosage.
Recovery of lower extremity strength.
Time required to the recovery of casual movement of the lower extremities
Quality of Recovery Scale (QoR)
40-item quality of recovery score, QoR-40

Full Information

First Posted
September 28, 2022
Last Updated
February 23, 2023
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05579223
Brief Title
Intrathecal Hydromorphone for Postoperative Pain of Anorectal Surgery
Acronym
IMPAS
Official Title
Intrathecal Hydromorphone for Postoperative Pain of Anorectal Surgery: A Randomized, Double-blind, Parallel, Placebo-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 17, 2022 (Actual)
Primary Completion Date
October 20, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain, Post Operative Pain, Anorectal Disorder, Analgesia
Keywords
hydromorphone, intrathecal opioid, post operative pain, anorectal surgery, placebo

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intrathecal Hydromorphone Group (ITHM)
Arm Type
Experimental
Arm Description
Dosage Form: Hydromorphone Hydrochloride Injection 2mg:2ml. Dosage: 75 μg+ 5% glucose injection diluted to 1.5ml. Frequency and Duration: i.t., st
Arm Title
Intrathecal Placebo Group (ITPO)
Arm Type
Placebo Comparator
Arm Description
Dosage Form: 5% glucose injection, 100ml/Package. Dosage: 1.5ml. Frequency and Duration: i.t., st
Intervention Type
Drug
Intervention Name(s)
Intrathecal Hydromorphone Mono Injection
Other Intervention Name(s)
ITHM
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Intrathecal Placebo Mono Injection
Other Intervention Name(s)
ITPO
Intervention Description
Placebo: 5% glucose injection. Administration: subarachnoid space mono bolus inject, 1.5ml, Speed ≤ 0.5 ml/s
Primary Outcome Measure Information:
Title
Numerical Rating Scale Pain Scores (NRS score for pain)
Description
NRS for pain (0-10) with movement 12 hours after spinal administration
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.
Secondary Outcome Measure Information:
Title
NRS score at rest/with movement
Description
NRS score for pain (0-10) with movement, and at rest.
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.
Title
Highest pain NRS (0-10) in previous 12 hours
Description
NRS score for pain (0-10) with movement or at rest and the time.
Time Frame
At 12 hours after spinal administration.
Title
Severity and incidence of any opioid-related complication at each time point
Description
Including: nausea, vomiting, constipation, diarrhea, itching, dry mouth, dizziness, numbness, depression, anxiety, fever, skin rash, urinary retention, Etc.
Time Frame
All data will be collected by patient interview at 1, 3, 6, 12, 24 and 36 hours after spinal administration.
Title
Total non-opioid analgesic consumption
Description
Total non-opioid analgesic consumption at 12, 24 and 36 hours after spinal administration, mainly intravenous parecoxib injection dosage.
Time Frame
All data will be collected by patient interview at 12, 24 and 36 hours after spinal administration.
Title
Recovery of lower extremity strength.
Description
Time required to the recovery of casual movement of the lower extremities
Time Frame
Data will be collected by patient interview at 12 hours after spinal administration.
Title
Quality of Recovery Scale (QoR)
Description
40-item quality of recovery score, QoR-40
Time Frame
At 12, 24 and 36 hours post spinal administration.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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, Parecoxib 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiangtao Xu, M.D.
Phone
86-17172123474
Email
xujiangtao@xinhuamed.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Zhe Zhu, M.D.
Phone
86-13917201975
Email
zhuzhe@xinhuamed.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiangtao Xu, M.D.
Organizational Affiliation
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
20092
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Shi, MD PhD
Phone
86-021-25076143
Email
XinhuaHospitalEC@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

Intrathecal Hydromorphone for Postoperative Pain of Anorectal Surgery

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