Seoul National University Hospital
Seoul, KS013, South Korea
Location status: Recruiting
NCT Number: NCT06761989
This is a prospective randomized open-label noninferiority trial that compares intrathecal morphine injection and continuous wound infiltration after open pancreaticoduodenectomy.
Interested in participating?
Request Info19 year and older
All sexes
Interventional
Not applicable
Seoul, KS013, South Korea
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: Postoperative days 1 to 3
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.
Time frame: Postoperative days 0 to 3
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.
Time frame: Postoperative days 0 to 3
The cumulative fentanyl equivalent dose used at 6, 12, 24, 48, and 72 hours after the end of anesthesia is assessed.
Time frame: Postoperative days 1 to 3
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.
Time frame: Within 1 week after surgery
Postoperative complications are assessed with the comprehensive complication index.
Contact information is provided by the study sponsor or research team.
Seoul National University Hospital
Other
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
Acronym: ITM_PPPD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07442123
Agnosia, Arthropathy of Knee
Ankara, Turkey (Türkiye)
View Trial DetailsNCT04094246
Acupuncture, Ear, Agnosia
West Point, New York, United States
View Trial DetailsNCT04375826
Agnosia, Nervous System Diseases
Seoul, South Korea
View Trial DetailsNCT05315596
Adult, Agnosia
Jena, Germany
View Trial Details