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

Lawson Health Research Institute

Status: Completed

Conditions: Hepatectomy

Treatments: Drug: Saline; Drug: Lidocaine; Drug: Ketamine; Drug: Lidocaine+ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT03391427

17003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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124 participants in 4 patient groups, including a placebo group

Lidocaine

Experimental group

Description:

This group will receive lidocaine infusion perioperatively

Treatment:

Drug: Lidocaine

Ketamine

Experimental group

Description:

This group will receive ketamine infusion perioperatively

Treatment:

Drug: Ketamine

Lidocaine+ketamine

Experimental group

Description:

This group will receive a combination of lidocaine and ketamine infusion, perioperatively

Treatment:

Drug: Lidocaine+ketamine

placebo

Placebo Comparator group

Description:

This group will receive saline infusion as placebo perioperatively

Treatment:

Drug: Saline