IMPAS: Intrathecal Hydromorphone for Postoperative Pain of Anorectal Surgery

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other)

Overall Status

Recruiting

CT.gov ID

NCT05579223

Collaborator

(none)

150

Enrollment

Location

Arms

12.4

Anticipated Duration (Months)

12.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Pain Post Operative Pain Anorectal Disorder Analgesia	Drug: Intrathecal Hydromorphone Mono Injection Drug: Intrathecal Placebo Mono Injection	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 17, 2022

Anticipated Primary Completion Date :

Oct 20, 2023

Anticipated Study Completion Date :

Oct 30, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Numerical Rating Scale Pain Scores (NRS score for pain) [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 Outcome Measures

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.]
NRS score for pain (0-10) with movement, and at rest.
Highest pain NRS (0-10) in previous 12 hours [At 12 hours after spinal administration.]
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 [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.
Total non-opioid analgesic consumption [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 injection dosage.
Recovery of lower extremity strength. [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
Quality of Recovery Scale (QoR) [At 12, 24 and 36 hours post spinal administration.]
40-item quality of recovery score, QoR-40

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

1. Any contraindications to spinal anesthesia and intrathecal analgesia.
1. Complex co-morbidities, including

Severe infection,
Respiratory insufficiency,
History of psychiatric or neurological disorders and other cognitive impairments

1. Chronic pain syndrome or current opioid use >10mg oral morphine equivalents/day
1. Allergy or intolerance to hydromorphone, Parecoxib
1. Clinical diagnosis of obstructive sleep apnea syndrome(OSAS)
1. History of drug abuse
1. Women who are breastfeeding or pregnant
1. Participation in other clinical trials within three months
1. Already participated in this study once
1. Not considered suitable for the clinical trial by the investigators