Pain ManagementITM_PPPDNCT06761989
Intrathecal Morphine Injection Versus Continuous Wound Infiltration After Pancreaticoduodenectomy
A study testing Intrathecal morphine injection and Continuous wound infiltration in people with Pain Management and Pain, Postoperative, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This is a prospective randomized open-label noninferiority trial that compares intrathecal morphine injection and continuous wound infiltration after open pancreaticoduodenectomy. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pain Management, Pain, Postoperative
- What is being tested?
- Intrathecal morphine injection and Continuous wound infiltration
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Jan 2025to 7 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, Seoul, KS013
Hojin Lee, MD, PhD, 82-2-2072-2467, hjpainfree@snu.ac.kr
About this study
Official title: 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
This is a prospective randomized open-label noninferiority trial that compares intrathecal morphine injection and continuous wound infiltration after open pancreaticoduodenectomy.
Read the 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
- Being tested
- Intrathecal morphine injection, Continuous wound infiltration
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal morphine injectionDrug
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 infiltrationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Continuous wound infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Postoperative days 1 to 3
Pain intensity at rest and on cough assessed at 2, 24, 48, and 72 hours from end of anesthesia
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.
Measured: Postoperative days 0 to 3
Cumulative dose of opioid use at 6, 12, 24, 48, and 72 hours after end of anesthesia
The cumulative fentanyl equivalent dose used at 6, 12, 24, 48, and 72 hours after the end of anesthesia is assessed.
Measured: Postoperative days 0 to 3
Quality of recovery at 24, 48, and 72 hours from the end of anesthesia
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.
Measured: Postoperative days 1 to 3
Postoperative complications
Postoperative complications are assessed with the comprehensive complication index.
Measured: Within 1 week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start15 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion7 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hojin Lee, MD, PhD, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761989
- Sponsor's protocol ID
- H-2411-020-1585
- Acronym
- ITM_PPPD
- Status last verified
- Mar 2025
- First submitted
- 30 Dec 2024
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yoon S, Kim T, Lee HJ, Park N, Jung HS, Cho YJ, Kwon W, Park JS, Jung CW, Jang JY. A randomized, noninferiority clinical trial of Single-Shot Intrathecal Morphine versus Continuous Wound Infiltration for postoperative pain control after open pancreatoduodenectomy. Br J Surg. 2026 Jul 6:znag088. doi: 10.1093/bjs/znag088. Online ahead of print.
PubMed 42403225
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06761989
- Acronym / sponsor ID
- ITM_PPPD / H-2411-020-1585
- Conditions
- Pain Management, Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 7 Jan 2027 (estimated)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intrathecal morphine injection | Experimental | Drug: Intrathecal morphine injectionA 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. |
| Continuous wound infiltration | Active comparator | Device: Continuous wound infiltrationA 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrathecal morphine injectionA 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. | Drug | Intrathecal morphine injection |
| Continuous wound infiltrationPrior 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. | Device | Continuous wound infiltration |
Primary outcome
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
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.
5 secondary outcomes
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
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
Cumulative dose of opioid use at 6, 12, 24, 48, and 72 hours after end of anesthesia
Time frame: Postoperative days 0 to 3
Quality of recovery at 24, 48, and 72 hours from the end of anesthesia
Time frame: Postoperative days 1 to 3
Postoperative complications
Time frame: Within 1 week after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Derived from this study: PubMed 42403225Yoon S, Kim T, Lee HJ, Park N, Jung HS, Cho YJ, Kwon W, Park JS, Jung CW, Jang JY. A randomized, noninferiority clinical trial of Single-Shot Intrathecal Morphine versus Continuous Wound Infiltration for postoperative pain control after open pancreatoduodenectomy. Br J Surg. 2026 Jul 6:znag088. doi: 10.1093/bjs/znag088. Online ahead of print.
- Individual participant dataSharing planned: Undecided
Related trials for Pain Management
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrathecal morphine injection and Continuous wound infiltration in people with Pain Management and Pain, Postoperative, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ho-jin Lee, M.D., PhD. (+82-2-2072-0039, hjpainfree@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06761989, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.