Pain Management, Pain, Postoperative
Conditions
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.
Interventions
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.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean pain intensity on cough assessed by K-DVRPS at 24, 48, and 72 hours from the end of anesthesia | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| Pain intensity at rest and on cough assessed at 2, 24, 48, and 72 hours from end of anesthesia | 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. |
| Cumulative dose of opioid use at 6, 12, 24, 48, and 72 hours after end of anesthesia | 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. |
| Quality of recovery at 24, 48, and 72 hours from the end of anesthesia | 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. |
| Postoperative complications | Within 1 week after surgery | Postoperative complications are assessed with the comprehensive complication index. |
Countries
South Korea
Contacts
Primary ContactHo-jin Lee, M.D., PhD.
Outcome results
None listed