Peri-Operative Lidocane, Ketamine, or Lidocane and Ketamine Combination, Infusion for Patients Undergoing Spine Surgery

• Sponsor: Beth Israel Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01983020
• Collaborator: (none)
• Enrollment: 46
• Location: 1
• Arms: 4
• Duration (Months): 21.1
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

This study has been designed as a controlled clinical trial to evaluate the efficacy of brief lidocaine infusion, brief ketamine infusion and a lidocaine/ketamine combined infusion when added to conventional opioid therapy following major spine surgery, as well as to evaluate the effects of the lidocaine/ketamine pain protocol on the feasibility of performing routine intraoperative neurophysiology during spine surgery in adults and determine whether this infusion protocol is compatible with intraoperative neurophysiology on spine surgery patients. If one or more of the approaches is confirmed as efficacious and safe, it could have a significant impact on the routine management of postoperative pain in this context.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Lidocaine; Drug: Ketamine; Other: Saline	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Randomized Double Blind Comparison of Peri-Operative Standard Analgesia With Peri-Operative Lidocane, Ketamine, or Lidocane and Ketamine Combination, Infusion for Patients Undergoing Spine Surgery
• Study Start Date: Apr 1, 2011
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ketamine Ketamine infused at 0.25 mg/kg/hour.	Drug: Ketamine
Experimental: Lidocaine Lidocaine infused at 0.5 mg/kg/hour.	Drug: Lidocaine
Experimental: Ketamine and Lidocaine Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour	Drug: Lidocaine; Drug: Ketamine
Placebo Comparator: Placebo Placebo (saline) given to compare usual treatment against active agents in post operative pain management.	Other: Saline

Outcome Measures

Primary Outcome Measures

1. Pain Intensity [postoperative day 1 - 3]

   The primary outcome will be average pain intensity at rest on postoperative day 1 - 3. Pain Intensity rated from 0 (none) to 10 (severe).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Male and Female >/= 18 years of age Patients undergoing first-time fusion surgery or surgery to revise a prior fusion Able to read, write and speak in English, and able to give informed consent for the study

Exclusion Criteria:

Any disease associated with major organ dysfunction renal dysfunction hepatic dysfunction cardiac dysfunction

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Medical Center	New York	New York	United States	10003

Sponsors and Collaborators

• Beth Israel Medical Center

Investigators

• Principal Investigator: Ronald Kaplan, MD, Beth Israel Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Beth Israel Medical Center
• ClinicalTrials.gov Identifier: NCT01983020
• Other Study ID Numbers: IRB 073-10
• First Posted: Nov 13, 2013
• Last Update Posted: May 15, 2017
• Last Verified: Apr 1, 2017

• Additional relevant MeSH terms: Pain, Postoperative; Lidocaine; Ketamine

Study Results

Participant Flow

Arm/Group Title	Ketamine	Lidocaine	Ketamine and Lidocaine	Placebo
Arm/Group Description	Ketamine infused at 0.25 mg/kg/hour. Ketamine	Lidocaine infused at 0.5 mg/kg/hour. Lidocaine	Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour Lidocaine Ketamine	Placebo (saline) given to compare usual treatment against active agents in post operative pain management.
Period Title: Overall Study
STARTED	12	11	12	11
COMPLETED	12	11	12	11
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Ketamine	Lidocaine	Ketamine and Lidocaine	Placebo	Total
Arm/Group Description	Ketamine infused at 0.25 mg/kg/hour. Ketamine	Lidocaine infused at 0.5 mg/kg/hour. Lidocaine	Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour Lidocaine Ketamine	Placebo (saline) given to compare usual treatment against active agents in post operative pain management.	Total of all reporting groups
Overall Participants	12	11	12	11	46
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.8 (11.85)	55.16 (16.23)	50.3 (11.5)	56.3 (12.7)	54.39 (13.08)
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	12 100%	11 100%	12 100%	11 100%	46 100%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	8 66.7%	7 63.6%	8 66.7%	8 72.7%	31 67.4%
Male	4 33.3%	4 36.4%	4 33.3%	3 27.3%	15 32.6%
Region of Enrollment (participants) [Number]
United States	12 100%	11 100%	12 100%	11 100%	46 100%

Outcome Measures

1. Primary Outcome

Title	Pain Intensity
Description	The primary outcome will be average pain intensity at rest on postoperative day 1 - 3. Pain Intensity rated from 0 (none) to 10 (severe).
Time Frame	postoperative day 1 - 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ketamine	Lidocaine	Ketamine and Lidocaine	Placebo
Arm/Group Description	Ketamine infused at 0.25 mg/kg/hour. Ketamine	Lidocaine infused at 0.5 mg/kg/hour. Lidocaine	Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour Lidocaine Ketamine	Placebo (saline) given to compare usual treatment against active agents in post operative pain management.
Measure Participants	12	11	12	11
Mean (Standard Deviation) [units on a scale]	6.29 (2.42)	5.76 (2.25)	5.51 (2.60)	6.40 (2.59)

Adverse Events

Arm/Group Title	Ketamine		Lidocaine		Ketamine and Lidocaine		Placebo
Arm/Group Description	Ketamine infused at 0.25 mg/kg/hour. Ketamine		Lidocaine infused at 0.5 mg/kg/hour. Lidocaine		Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour Lidocaine Ketamine		Placebo (saline) given to compare usual treatment against active agents in post operative pain management.
All Cause Mortality
	Ketamine		Lidocaine		Ketamine and Lidocaine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Ketamine		Lidocaine		Ketamine and Lidocaine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/12 (8.3%)		0/11 (0%)		3/12 (25%)		1/11 (9.1%)
Cardiac disorders
Tachycardia	0/12 (0%)	0	0/11 (0%)	0	2/12 (16.7%)	8	1/11 (9.1%)	1
Low Blood Pressure	0/12 (0%)	0	0/11 (0%)	0	1/12 (8.3%)	1	1/11 (9.1%)	1
Eye disorders
Diplopia	1/12 (8.3%)	4	0/11 (0%)	0	0/12 (0%)	0	0/11 (0%)	0
Respiratory, thoracic and mediastinal disorders
Respiratory Depression	0/12 (0%)	0	0/11 (0%)	0	2/12 (16.7%)	2	0/11 (0%)	0
Other (Not Including Serious) Adverse Events
	Ketamine		Lidocaine		Ketamine and Lidocaine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/12 (16.7%)		2/11 (18.2%)		6/12 (50%)		6/11 (54.5%)
Eye disorders
Blurred Vision	0/12 (0%)	0	0/11 (0%)	0	1/12 (8.3%)	1	1/11 (9.1%)	1
Gastrointestinal disorders
Nausea	2/12 (16.7%)	2	0/11 (0%)	0	1/12 (8.3%)	1	0/11 (0%)	0
General disorders
Cold Sweats	1/12 (8.3%)	2	0/11 (0%)	0	0/12 (0%)	0	0/11 (0%)	0
Sedation	0/12 (0%)	0	1/11 (9.1%)	1	0/12 (0%)	0	2/11 (18.2%)	2
Lightheadedness	0/12 (0%)	0	0/11 (0%)	0	1/12 (8.3%)	1	0/11 (0%)	0
Headache	0/12 (0%)	0	0/11 (0%)	0	1/12 (8.3%)	1	1/11 (9.1%)	1
Itching	0/12 (0%)	0	0/11 (0%)	0	1/12 (8.3%)	1	1/11 (9.1%)	1
Psychiatric disorders
Anxiety	1/12 (8.3%)	1	0/11 (0%)	0	0/12 (0%)	0	1/11 (9.1%)	2
Confusion	0/12 (0%)	0	2/11 (18.2%)	2	0/12 (0%)	0	0/11 (0%)	0
Paranoia	0/12 (0%)	0	0/11 (0%)	0	1/12 (8.3%)	1	0/11 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.