Intrathecal Morphine Injection Versus Continuous Wound Infiltration After Pancreaticoduodenectomy

NCT06761989 | Recruiting DMC

• 1 other identifier: H-2411-020-1585
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective randomized open-label noninferiority trial that compares intrathecal morphine injection and continuous wound infiltration after open pancreaticoduodenectomy.

Conditions

Pain Management; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Mean pain intensity on cough assessed by K-DVRPS at 24, 48, and 72 hours from the end of anesthesia

  The K-DVPRS (Korean version of Defense and Veterans Pain Rating Scale), ranging from 0 to 10, is used to assess postoperative pain on cough at 24, 48, and 72 hours after the end of anesthesia. The mean K-DVPRS pain score for 3 time points is compared between two groups.

  Postoperative days 1 to 3

Secondary Outcomes (5)

• Mean pain intensity at rest assessed by K-DVRPS at 24, 48, and 72 hours from the end of anesthesia

  Postoperative days 1 to 3

• Pain intensity at rest and on cough assessed at 2, 24, 48, and 72 hours from end of anesthesia

  Postoperative days 0 to 3

• Cumulative dose of opioid use at 6, 12, 24, 48, and 72 hours after end of anesthesia

  Postoperative days 0 to 3

• Quality of recovery at 24, 48, and 72 hours from the end of anesthesia

  Postoperative days 1 to 3

• Postoperative complications

  Within 1 week after surgery

Study Arms (2)

Intrathecal morphine injection

EXPERIMENTAL

A single dose of intrathecal morphine is administered prior to induction of general anesthesia. Other postoperative pain management follows the institution's protocol including intravenous patient controlled analgesia.

Drug: Intrathecal morphine injection

Continuous wound infiltration

ACTIVE COMPARATOR

A catheter is inserted at preperitoneal space at the end of surgery and ropivacaine is continuously infused until postoperative day 3. Other postoperative pain management follows the institution's protocol including intravenous patient controlled analgesia.

Device: Continuous wound infiltration

Interventions

Intrathecal morphine injection DRUG

A single dose of intrathecal morphine is administered prior to induction of general anesthesia. The patient is placed in the lateral decubitus position on the bed and a 25 guage quincke spinal needle is inserted intrathecally at the L4/5 median or paramedian approach to administer 0.2 mg of morphine.

Intrathecal morphine injection

Continuous wound infiltration DEVICE

Prior to closure of the abdominal wall, a catheter is placed in the preperitoneal space lateral to the surgical incision through the tunneler. The catheter is connected to a prepared infusion pump (275 ml of 0.5% ropivacaine, 4 ml/hr/catheter), and the remaining catheter protruding from the abdomen is secured with a catheterization dressing. The preperitoneal catheter is removed in the afternoon of postoperative day 3.

Continuous wound infiltration

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 19 years of age or older
• Scheduled for elective open pancreaticoduodenectomy or pylorus preseriving pancreaticoduodenectomy
• Disease of periampullary lesions
• Perfromance status assessed with ECOG score is 0 or 1 at the time of enrollment
• Able to provide written informed consent to participate in the study, understand the procedures of this study, and complete patient-reported questionnaires
• American Society of Anesthesiologists physical status I to III

You may not qualify if:

• Hypersensitivity to medications used for pain control (fentanyl, ropivacaine, morphine, acetaminophen, NSAIDs)
• Cognitive impairment that affects using patient-controlled analgesia device or answering patient-reported questionnaires
• Infection or anatomical abnormalities of the abdominal wall and skin that preclude catheterization for continuous wound infiltration
• Contraindicated for intrathecal injection due to any coagulation disorder or continued use of anticoagulants
• Have a major medical or psychiatric illness that would affect response to treatment
• History of chronic pain, or chronic use of analgesics or psychiatric medications
• Have severe liver or kidney disease
• Anyone who are not appropriate for the study in the opinion of the investigators

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, KS013, South Korea

RECRUITING

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Central Study Contacts

Ho-jin Lee, M.D., PhD.

CONTACT

+82-2-2072-0039; hjpainfree@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Model Details: Stratify patients who receive preoperative chemotherapy and those who do not in a 1:3 ratio, so that 26 and 78 patients are assigned to each stratum out of a total of 104 patients. Then, within each stratum, block randomization is performed, with blocks of size 4 containing two intrathecal morphine and two wound infiltration groups, and blocks of size 6 containing three intrathecal morphine and three wound infiltration groups.

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 7, 2025
• Study Start: January 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 7, 2027
• Last Updated: March 19, 2025

Record last verified: 2025-03

Locations

KR (1)