Ketamine, Lidocaine and Combination for Postoperative Analgesia in Open Liver Resection

Hepatectomy Clinical Trial

Official title:

Ketamine, Lidocaine and Combination for Postoperative Analgesia in Open Liver Resection: A Prospective, Randomized, Four-arm, Double Blind, Placebo Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03391427
• Other study ID #: 17003
• Status: Completed
• Phase: N/A
• Start date: March 1, 2011
• Est. completion date: December 30, 2017

Study information

• Verified date: July 2023
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: December 30, 2017
• Est. primary completion date: November 4, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatectomy

Intervention

Drug:
• Lidocaine
This group will receive lidocaine infusion
• Ketamine
This group will receive Ketamine infusion
• Lidocaine+ketamine
This group will receive mixture of ketamine and lidocaine infusion
• Saline
This group will receive saline infusion

Locations

Country	Name	City	State
Canada	London Health Sciences Center	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (3)

Harvey KP, Adair JD, Isho M, Robinson R. Can intravenous lidocaine decrease postsurgical ileus and shorten hospital stay in elective bowel surgery? A pilot study and literature review. Am J Surg. 2009 Aug;198(2):231-6. doi: 10.1016/j.amjsurg.2008.10.015. Epub 2009 Mar 12. — View Citation

Ko JS, Choi SJ, Gwak MS, Kim GS, Ahn HJ, Kim JA, Hahm TS, Cho HS, Kim KM, Joh JW. Intrathecal morphine combined with intravenous patient-controlled analgesia is an effective and safe method for immediate postoperative pain control in live liver donors. Liver Transpl. 2009 Apr;15(4):381-9. doi: 10.1002/lt.21625. — View Citation

Rakic AM, Golembiewski J. Low-dose ketamine infusion for postoperative pain management. J Perianesth Nurs. 2009 Aug;24(4):254-7. doi: 10.1016/j.jopan.2009.05.097. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption	Total milligrams of opioids consumed would be measured	24 hr
Secondary	Opioid consumption	Total milligrams of opioids consumed would be measured. Higher opioid consumption indicates worse pain control.	48 hrs
Secondary	Opioid related side effects	Questions regarding all opioid related side effects will be asked. These will include inquiry regarding nausea, vomiting, hallucinations, sedation, respiratory depression, pruritus	72 hrs
Secondary	Chronic pain	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.	6 weeks
Secondary	Patient satisfaction	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.	72 hrs
Secondary	Chronic pain	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.	12 weeks
Secondary	Opioid consumption	Total milligrams of opioids consumed would be measured. Higher opioid consumption indicates worse pain control.	72 hrs