Total milligrams of opioids consumed would be measured
Ketamine, Lidocaine and Combination for Postoperative Analgesia in Open Liver Resection
Brief Summary
Lidocaine and ketamine both are being used for perioperative analgesia. Perioperative lidocaine infusion has been shown to reduce postoperative pain and opioid consumption. Perioperative low dose Ketamine has shown improved postoperative pain and reduced opioid usage. We therefore tested the hypothesis that the combination would provide better analgesia in the milieu of intrathecal morphine.
Intervention / Treatment
Lidocaine, ketamine, combination and placebo are being evaluated for treating postoperative pain in major liver resection
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Lidocaine (DRUG)This group will receive lidocaine infusion
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Ketamine (DRUG)This group will receive Ketamine infusion
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Lidocaine+ketamine (DRUG)This group will receive mixture of ketamine and lidocaine infusion
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Saline (DRUG)This group will receive saline infusion
Condition or Disease
- Hepatectomy
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 18 Years to 80 Years |
| Enrollment: | 124 (ACTUAL) |
| Funded by: | Other |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
MaskingAll persons are blinded as the drug is formulated by the investigator who is not the care giver or outcomes assessor TRIPLE:
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Clinical Trial Dates
| Start date: | Mar 01, 2011 | ACTUAL |
|---|---|---|
| Primary Completion: | Nov 04, 2015 | ACTUAL |
| Completion Date: | Dec 30, 2017 | ACTUAL |
| Study First Posted: | Jan 05, 2018 | ACTUAL |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Jul 04, 2023 |
Sponsors / Collaborators
Lead Sponsor:
Lawson Health Research Institute
Responsible Party:
N/A
Location
All study participants were monitored according to American Society of Anesthesiologists guidelines. All received intrathecal morphine (300 to 400 mcg) at L3-4 interspace via 25 G Whitacre needle. Participants were then randomized (computer generated) into one of four groups.
General anesthesia was induced and endotracheal intubation was done. Immediately, after intubation, Lidocaine group (L) received a Lidocaine infusion at 0.33 mg/kg/h.
The Ketamine group (K) received a ketamine infusion at 70 mcg/Kg/h. The Lidocaine-Ketamine group (LK) received a Lidocaine infusion at 0.33 mg/kg/h plus a Ketamine infusion at 70 mcg/Kg/h.
The control group (P) received a normal saline infusion to keep the blind. The infusions were stopped approximately 30-45 minute before the completion of surgery.
All participants received a hydromorphone patient-controlled analgesia (PCA) via a pump. All were given acetaminophen 650 mg every 6 hrs for 4 days.
Postoperatively, participants were monitored for nausea, vomiting, sedation, respiratory depression, light-headedness, perioral numbness, pruritus, disturbed dreams and hallucinations.
Postoperative Hydromorphone consumption for the first, second and third day was recorded from the chart maintained by acute pain service team who were blinded to the group assignment.
After the operation, study participants were interviewed at regular intervals by a blinded investigator about their current pain level, as well as satisfaction with pain management. They were also be questioned regarding the presence and severity of opioid-related side effects (nausea, vomiting, sedation, respiratory depression and, pruritus) and light-headedness, perioral numbness, disturbed dreams and hallucinations. Hospital charts were reviewed and data collected to analyze time to request for additional analgesia and total consumption of opioids, non-opioid analgesics, anti-emetics, and antipruritics within the first 72 hours postoperatively.
General anesthesia was induced and endotracheal intubation was done. Immediately, after intubation, Lidocaine group (L) received a Lidocaine infusion at 0.33 mg/kg/h.
The Ketamine group (K) received a ketamine infusion at 70 mcg/Kg/h. The Lidocaine-Ketamine group (LK) received a Lidocaine infusion at 0.33 mg/kg/h plus a Ketamine infusion at 70 mcg/Kg/h.
The control group (P) received a normal saline infusion to keep the blind. The infusions were stopped approximately 30-45 minute before the completion of surgery.
All participants received a hydromorphone patient-controlled analgesia (PCA) via a pump. All were given acetaminophen 650 mg every 6 hrs for 4 days.
Postoperatively, participants were monitored for nausea, vomiting, sedation, respiratory depression, light-headedness, perioral numbness, pruritus, disturbed dreams and hallucinations.
Postoperative Hydromorphone consumption for the first, second and third day was recorded from the chart maintained by acute pain service team who were blinded to the group assignment.
After the operation, study participants were interviewed at regular intervals by a blinded investigator about their current pain level, as well as satisfaction with pain management. They were also be questioned regarding the presence and severity of opioid-related side effects (nausea, vomiting, sedation, respiratory depression and, pruritus) and light-headedness, perioral numbness, disturbed dreams and hallucinations. Hospital charts were reviewed and data collected to analyze time to request for additional analgesia and total consumption of opioids, non-opioid analgesics, anti-emetics, and antipruritics within the first 72 hours postoperatively.
Participant Groups
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This group will receive lidocaine infusion perioperatively
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This group will receive ketamine infusion perioperatively
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This group will receive a combination of lidocaine and ketamine infusion, perioperatively
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This group will receive saline infusion as placebo perioperatively
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Maximum Age: | 80 |
| Age Groups: | Adult / Older Adult |
| Healthy Volunteers: | Yes |
Inclusion Criteria:
* ASA physical status 2-4
* Elective major liver resection
* Signed informed consent
Exclusion Criteria:
* ICU admission after surgery
* tracheal extubation not planned after surgery
* language barrier
* mental impairment
* severe coagulopathy
* chronic pain or opioid dependance or both
* alcohol/substance abuse
* allergy to the study drugs
* refusal for spinal
* infection at site of spinal
* ASA physical status 2-4
* Elective major liver resection
* Signed informed consent
Exclusion Criteria:
* ICU admission after surgery
* tracheal extubation not planned after surgery
* language barrier
* mental impairment
* severe coagulopathy
* chronic pain or opioid dependance or both
* alcohol/substance abuse
* allergy to the study drugs
* refusal for spinal
* infection at site of spinal
Primary Outcomes
Secondary Outcomes
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Total milligrams of opioids consumed would be measured. Higher opioid consumption indicates worse pain control.
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Questions regarding all opioid related side effects will be asked. These will include inquiry regarding nausea, vomiting, hallucinations, sedation, respiratory depression, pruritus
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Incidence of chronic pain at 6 weeks will be noted by a numerical rating scale of 1-10 where 0 would be no pain at all and 10 would be worst possible pain. This is standard pain assessment tool. Lower numbers indication better outcomes.
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Patient satisfaction will be noted using a numeric rating scale; where 0 will be completely unsatisfied and 10 will be completely satisfied. Higher values depict better satisfaction and better outcomes.
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Incidence of chronic pain at 12 weeks will be noted by a numerical rating scale of 1-10 where 0 would be no pain at all and 10 would be worst possible pain. This is standard pain assessment tool. Lower numbers indication better outcomes.
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Total milligrams of opioids consumed would be measured. Higher opioid consumption indicates worse pain control.
More Details
| NCT Number: | NCT03391427 |
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| Other IDs: | 17003 |
| Study URL: | https://clinicaltrials.gov/study/NCT03391427 |
Last updated: Sep 29, 2023