Clinical trial NCT05579223: Intrathecal Hydromorphone for Postoperative Pain of Anorectal Surgery
Official title: Intrathecal Hydromorphone for Postoperative Pain of Anorectal Surgery: A Randomized, Double-blind, Parallel, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Pain
Post Operative Pain
Anorectal Disorder
Analgesia
Keywords: hydromorphone
intrathecal opioid
post operative pain
anorectal surgery
placebo
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

  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

Primary outcomes:
measure: Numerical Rating Scale Pain Scores (NRS score for pain)
timeFrame: 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:
measure: NRS score at rest/with movement
timeFrame: 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.
measure: Highest pain NRS (0-10) in previous 12 hours
timeFrame: At 12 hours after spinal administration.
measure: Severity and incidence of any opioid-related complication at each time point
timeFrame: All data will be collected by patient interview at 1, 3, 6, 12, 24 and 36 hours after spinal administration.
measure: Total non-opioid analgesic consumption
timeFrame: All data will be collected by patient interview at 12, 24 and 36 hours after spinal administration.
measure: Recovery of lower extremity strength.
timeFrame: Data will be collected by patient interview at 12 hours after spinal administration.
measure: Quality of Recovery Scale (QoR)
timeFrame: At 12, 24 and 36 hours post spinal administration.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Jiangtao Xu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: