Intrathecal Morphine Injection Versus Continuous Wound Infiltration After Pancreaticoduodenectomy (ITM_PPPD)
Effect of Single-Shot Intrathecal Morphine Injection Versus Continuous Wound Infiltration on Postoperative Pain After Pancreaticoduodenectomy: a Prospective, Open-Label, Randomized Controlled, Non-Inferiority Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ho-jin Lee, M.D., PhD.
- Phone Number: +82-2-2072-0039
- Email: hjpainfree@snu.ac.kr
Study Locations
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Seoul, Korea, Republic of, KS013
- Recruiting
- Seoul National University Hospital
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Contact:
- Hojin Lee, MD, PhD
- Phone Number: 82-2-2072-2467
- Email: hjpainfree@snu.ac.kr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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.
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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.
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|
Active Comparator: 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean pain intensity on cough assessed by K-DVRPS at 24, 48, and 72 hours from the end of anesthesia
Time Frame: Postoperative days 1 to 3
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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.
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Postoperative days 1 to 3
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mean pain intensity at rest assessed by K-DVRPS at 24, 48, and 72 hours from the end of anesthesia
Time Frame: Postoperative days 1 to 3
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The K-DVPRS is used to assess postoperative pain at rest 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.
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Postoperative days 1 to 3
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Pain intensity at rest and on cough assessed at 2, 24, 48, and 72 hours from end of anesthesia
Time Frame: Postoperative days 0 to 3
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The K-DVPRS is used to assess postoperative pain at rest and on cough at 2, 24, 48, and 72 hours after the end of anesthesia, respectively.
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Postoperative days 0 to 3
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Cumulative dose of opioid use at 6, 12, 24, 48, and 72 hours after end of anesthesia
Time Frame: Postoperative days 0 to 3
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The cumulative fentanyl equivalent dose used at 6, 12, 24, 48, and 72 hours after the end of anesthesia is assessed.
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Postoperative days 0 to 3
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Quality of recovery at 24, 48, and 72 hours from the end of anesthesia
Time Frame: Postoperative days 1 to 3
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Quality of recovery is assessed with the Korean version of the EQ-5D-5L at 24, 48, and 72 hours after the end of anesthesia.
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Postoperative days 1 to 3
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Postoperative complications
Time Frame: Within 1 week after surgery
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Postoperative complications are assessed with the comprehensive complication index.
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Within 1 week after surgery
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-2411-020-1585
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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