Patients Receiving Hepatectomy Under General AnesthesiaNCT05208801
Analgesic Effect of Intrathecal Morphine Combined With Low Dose Local Anesthetics on Postoperative Analgesia After Liver Resection
A study testing Percutaneous injection, Morphine and Morphine+Bupivacaine in people with Patients Receiving Hepatectomy Under General Anesthesia, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Patients Receiving Hepatectomy Under General Anesthesia
- What is being tested?
- Percutaneous injection, Morphine and Morphine+Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Nov 2018to 18 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
About this study
Official title: Analgesic Effect of Intrathecal Morphine Combined With Low Dose Local Anesthetics on Postoperative Analgesia After Liver Resection: A Randomized, Controlled Preliminary Study
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.
Read the 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.
- Being tested
- Percutaneous injection, Morphine, Morphine+Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous injectionDrug
A sham procedure of 2 ml of 1% lidocaine injected percutaneously using the initial 25G needle for local anesthetics
MorphineDrug
Intrathecal injection of morphine 400mcg
Morphine+BupivacaineDrug
Intrathecal injection of 5mg of 0.5% bupivacaine chloride
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | a sham procedure of 2 ml of 1% lidocaine injected percutaneously using the initial 25G needle Receives: Drug: Percutaneous injection |
| Morphine | Active comparator | Not described Receives: Drug: Morphine |
| Morphine+bupivicaine | Experimental | Not described Receives: Drug: Morphine+Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first rescue analgesic
Time to first rescue analgesic during the first 72 hours after surgery (hr) was our primary outcome.
Measured: First 72 hours after surgery
Secondary outcomes (5)
Pain score after surgery (visual analogue scale, VAS)
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.
Measured: 30 minutes, 1 hours upon arrival of the Postoperative anesthesia care unit(PACU), 5 hours post surgery, 1 day post-surgery
Total fentanyl dose administered via intravenous patient-controlled analgesia (PCA)
Further assessment of pain control was done by comparing total opioid dosage via PCA.
Measured: First 48 hour post surgery
Additional rescue analgesics given to the patient
Rescue analgesics were given only upon patients request. This was evaluated for further assessment of pain control.
Measured: until 3 days post-surgery.
Sensory and motor block
Sensory and motor block was assessed for prolonged effects of intrathecal injection.
Measured: 30 minutes, 1 hours upon arrival of the Postoperative anesthesia care unit (PACU), 5 hours post surgery, 1 day post-surgery
Presence of complications (headache, nausea/vomiting, pruritus, respiratory depression, somnolence, low blood pressure, tingling, and shivering)
Common side effects to morphine or bupivacaine injections were assessed.
Measured: first 3 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start19 Nov 2018
- Primary completion18 Apr 2020
- Study completion18 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Receiving Hepatectomy Under General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bon-Nye Koo, Principal investigator, Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05208801
- Sponsor's protocol ID
- 4-2018-0838
- Status last verified
- Jan 2022
- First submitted
- 15 Dec 2021
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Intrathecal Morphine Combined With Low Dose Local Anesthetics on Postoperative Analgesia After Liver Resection: A Randomized, Controlled Preliminary Study
- ClinicalTrials.gov ID
- NCT05208801
- Acronym / sponsor ID
- 4-2018-0838
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 18 Apr 2020 (actual)
- Study completion
- 18 Apr 2020 (actual)
- First posted
- 26 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Drug: Percutaneous injectiona sham procedure of 2 ml of 1% lidocaine injected percutaneously using the initial 25G needle |
| Morphine | Active comparator | Drug: Morphine |
| Morphine+bupivicaine | Experimental | Drug: Morphine+Bupivacaine |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous injectionA sham procedure of 2 ml of 1% lidocaine injected percutaneously using the initial 25G needle for local anesthetics | Drug | Control |
| MorphineIntrathecal injection of morphine 400mcg | Drug | Morphine |
| Morphine+BupivacaineIntrathecal injection of 5mg of 0.5% bupivacaine chloride | Drug | Morphine+bupivicaine |
Primary outcome
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.
5 secondary outcomes
Pain score after surgery (visual analogue scale, VAS)
Time frame: 30 minutes, 1 hours upon arrival of the Postoperative anesthesia care unit(PACU), 5 hours post surgery, 1 day post-surgery
Total fentanyl dose administered via intravenous patient-controlled analgesia (PCA)
Time frame: First 48 hour post surgery
Additional rescue analgesics given to the patient
Time frame: until 3 days post-surgery.
Sensory and motor block
Time frame: 30 minutes, 1 hours upon arrival of the Postoperative anesthesia care unit (PACU), 5 hours post surgery, 1 day post-surgery
Presence of complications (headache, nausea/vomiting, pruritus, respiratory depression, somnolence, low blood pressure, tingling, and shivering)
Time frame: first 3 days post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bon-Nye Koo principal investigator
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous injection, Morphine and Morphine+Bupivacaine in people with Patients Receiving Hepatectomy Under General Anesthesia, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first rescue analgesic (time frame: First 72 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2022.