Skip to main content
Clinical Trials/NCT05208801
NCT05208801
Completed
Not Applicable

Analgesic Effect of Intrathecal Morphine Combined With Low Dose Local Anesthetics on Postoperative Analgesia After Liver Resection: A Randomized, Controlled Preliminary Study

Yonsei University1 site in 1 country90 target enrollmentNovember 19, 2018

Overview

Phase
Not Applicable
Intervention
Percutaneous injection
Conditions
Patients Receiving Hepatectomy Under General Anesthesia
Sponsor
Yonsei University
Enrollment
90
Locations
1
Primary Endpoint
Time to first rescue analgesic
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 19, 2018
End Date
April 18, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Factorial
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Arms & Interventions

Control

a sham procedure of 2 ml of 1% lidocaine injected percutaneously using the initial 25G needle

Intervention: Percutaneous injection

Morphine

Intervention: Morphine

Morphine+bupivicaine

Intervention: Morphine+Bupivacaine

Outcomes

Primary Outcomes

Time to first rescue analgesic

Time Frame: First 72 hours after surgery

Time to first rescue analgesic during the first 72 hours after surgery (hr) was our primary outcome.

Secondary Outcomes

  • Presence of complications (headache, nausea/vomiting, pruritus, respiratory depression, somnolence, low blood pressure, tingling, and shivering)(first 3 days post surgery)
  • Total fentanyl dose administered via intravenous patient-controlled analgesia (PCA)(First 48 hour post surgery)
  • Additional rescue analgesics given to the patient(until 3 days post-surgery.)
  • Pain score after surgery (visual analogue scale, VAS)(30 minutes, 1 hours upon arrival of the Postoperative anesthesia care unit(PACU), 5 hours post surgery, 1 day post-surgery)
  • Sensory and motor block(30 minutes, 1 hours upon arrival of the Postoperative anesthesia care unit (PACU), 5 hours post surgery, 1 day post-surgery)

Study Sites (1)

Loading locations...

Similar Trials