Analgesic Effect of Intrathecal Morphine Combined With Low Dose Local Anesthetics on Postoperative Analgesia After Liver Resection

Not Applicable

Completed

• Conditions: Patients Receiving Hepatectomy Under General Anesthesia
• Interventions: Drug: Percutaneous injection; Drug: Morphine+Bupivacaine; Drug: Morphine

• Registration Number: NCT05208801
• Lead Sponsor: Yonsei University

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.

Study Timeline

• Study Start: 2018-11-19
• Primary Completion: 2020-04-18
• Study Completion: 2020-04-18
• Study First Submitted: 2021-12-15
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-12
• Last Update Submitted: 2022-01-12
• Study First Posted: 2022-01-26
• Last Update Posted: 2022-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Control	Percutaneous injection	a sham procedure of 2 ml of 1% lidocaine injected percutaneously using the initial 25G needle
Morphine+bupivicaine	Morphine+Bupivacaine	-
Morphine	Morphine	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Presence of complications (headache, nausea/vomiting, pruritus, respiratory depression, somnolence, low blood pressure, tingling, and shivering)	first 3 days post surgery	Common side effects to morphine or bupivacaine injections were assessed.
Total fentanyl dose administered via intravenous patient-controlled analgesia (PCA)	First 48 hour post surgery	Further assessment of pain control was done by comparing total opioid dosage via PCA.
Additional rescue analgesics given to the patient	until 3 days post-surgery.	Rescue analgesics were given only upon patients request. This was evaluated for further assessment of pain control.
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	Visual analogue scale is a validated subjective measure for acute and chronic pain. Scores are measured on 10cm line where 0 represents no pain to 10cm representing the worst pain.
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	Sensory and motor block was assessed for prolonged effects of intrathecal injection.

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of