Intrathecal Morphine Injection Versus Continuous Wound Infiltration After Pancreaticoduodenectomy

NCT ID: NCT06761989

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-15
• Study Completion Date: 2027-01-07

Brief Summary

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

Detailed Description

Open pancreaticoduodenectomy causes severe postoperative pain due to the relatively large incision and tissue damage compared to other abdominal surgeries. Current Enhanced Recovery After Surgery (ERAS) guidelines recommend continuous wound infiltration for pancreaticoduodenectomy as an effective analgesic modality along with thoracic epidural analgesia. However, continuous wound infiltration is effective for somatic pain in the abdominal wall but not for visceral pain from the incision of internal organs. It also requires the placement of a catheter for several days after surgery, which can be inconvenient for patients.

Intrathecal morphine injection has been recommended as an effective analgesic method for abdominal surgery because they provide potent, long-lasting analgesia with a single injection and can provide equivalent analgesia with a much smaller dose compared to intravenous or oral morphine. Several previous studies have reported on the analgesic efficacy of a single intrathecal morphine injection including pancreaticoduodenectomy. However, no studies have compared a single intrathecal morphine injection with continuous wound infiltration for pancreaticoduodenectomy. To date, studies comparing the two methods of analgesia have only been reported in cesarean section and donor hepatectomy, and these studies either found no significant difference between the two methods of analgesia or reported that intrathecal morphine injection provided better analgesia in early postoperative period.

Therefore, the investigators will examine the effect of single intrathecal morphine injection for postoperative pain control in patients undergoing open pancreaticoduodenectomy to improve postoperative pain management and to explore its potential as one of the effective analgesic methods in ERAS protocol. To this end, the investigators will test non-inferiority between intrathecal morphine injection and continuous wound infiltration.

Conditions

Pain Management; Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intrathecal morphine injection

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.

Group Type: EXPERIMENTAL

Intrathecal morphine injection

Intervention Type: 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.

Continuous wound infiltration

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.

Group Type: ACTIVE_COMPARATOR

Continuous wound infiltration

Intervention Type: 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.

Interventions

Intrathecal morphine injection

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.

Intervention Type: DRUG

Continuous wound infiltration

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hojin Lee, MD, PhD

Associated Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seoul National University Hospital

Seoul, Seoul, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

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

Role: CONTACT

hjpainfree@snu.ac.kr

+82-2-2072-0039

Facility Contacts

Hojin Lee, MD, PhD

Role: primary

hjpainfree@snu.ac.kr

82-2-2072-2467

Other Identifiers

H-2411-020-1585

Identifier Type: -

Identifier Source: org_study_id