Clinical trial NCT05208801: Analgesic Effect of Intrathecal Morphine Combined With Low Dose Local Anesthetics on Postoperative Analgesia After Liver Resection
Official title: Analgesic Effect of Intrathecal Morphine Combined With Low Dose Local Anesthetics on Postoperative Analgesia After Liver Resection: A Randomized, Controlled Preliminary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients Receiving Hepatectomy Under General Anesthesia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 90
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Efficient postoperative pain control plays a vital part in the management of patients after surgery. In particular, major surgeries including hepatectomy cause intense postoperative pain that may result in cardiovascular or respiratory complications post-surgery. One of the current methods of postoperative pain control after hepatectomy involves a multimodal approach including intrathecal morphine injection immediately prior to surgery. Because morphine alone is inadequate for immediate postoperative pain control due to a late peak effect time of 6 hours, current literature advocates a combination injection including bupivacaine. However, higher doses of bupivacaine may inadvertently cause motor block or hemodynamic side effects. The aim of this study was to compare the effectiveness and side effects of intrathecal morphine combined with low dose bupivacaine against intrathecal morphine alone and no intrathecal injection.

Detailed description: All patients enrolled in the current study will receive intrathecal injections immediately prior to general anesthesia. The patient will be on his or her side in the fetal position and after palpating the back to secure the space between the 3rd and 4th lumbar spine, the area will be properly disinfected and draped with a sterile towel. Using a 25G needle, a small volume of 1% lidocaine will be injected at the proposed puncture site. For the control group, 2ml of 1% lidocaine will be injected subcutaneously with the 25G needle used during local anesthetic injection. For the morphine group and the morphine + bupivacaine group, a 25G pencil point spinal needle will be used to advance into the intrathecal space. After confirming intrathecal position of the needle by CSF regurgitation, morphine 400mg or morphine 400mcg+ bupivacaine 5mg each to a total volume of 2ml will be injected. Afterwards, all patients will undergo general anesthesia by the same method.

Eligibility criteria: Inclusion Criteria:

1. Age 19 years to no upper limit
2. Patients receiving liver resection under general anesthesia (Including open surgery and laparoscopic surgery)
3. American Society of Anesthesiologists (ASA) physical status 1,2

Exclusion Criteria:

1. Patients presenting with coagulopathy prior to surgery
2. Patients with neurological deficits
3. Patients with spinal anomaly or disorders
4. Patients with allergies to opioids or local anesthetics
5. Patients with severe respiratory, cardiovascular, renal, or hepatic disorders
6. Severe systemic infection or infections involving proposed intrathecal injection site
7. Patients with severe psychological disorders severe that may interfere with pain evaluation
8. Patients with chronic diseases that require opioids

Primary outcomes:
measure: Time to first rescue analgesic
timeFrame: First 72 hours after surgery
Secondary outcomes:
measure: Pain score after surgery (visual analogue scale, VAS)
timeFrame: 30 minutes, 1 hours upon arrival of the Postoperative anesthesia care unit(PACU), 5 hours post surgery, 1 day post-surgery
measure: Total fentanyl dose administered via intravenous patient-controlled analgesia (PCA)
timeFrame: First 48 hour post surgery
measure: Additional rescue analgesics given to the patient
timeFrame: until 3 days post-surgery.
measure: Sensory and motor block
timeFrame: 30 minutes, 1 hours upon arrival of the Postoperative anesthesia care unit (PACU), 5 hours post surgery, 1 day post-surgery
measure: Presence of complications (headache, nausea/vomiting, pruritus, respiratory depression, somnolence, low blood pressure, tingling, and shivering)
timeFrame: first 3 days post surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
name: Bon-Nye Koo
role: PRINCIPAL_INVESTIGATOR
References: