Intrathecal Hydromorphone for Postoperative Pain of Anorectal Surgery

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine150 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

150

Conditions

Acute Pain Post Operative Pain Anorectal Disorder Analgesia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Numerical Rating Scale Pain Scores (NRS score for pain)

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 Outcomes

NRS score at rest/with movement

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.

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

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

Time frame: 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.

Time frame: All data will be collected by patient interview at 1, 3, 6, 12, 24 and 36 hours after 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.

Time frame: All data will be collected by patient interview at 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

Time frame: 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

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