Abdominal Hysterectomy (& Wertheim)NCT00721110

Lidocaine and Ketamine in Abdominal Surgery

A study testing Lidocaine, Ketamine and Ketamine + Lidocaine in people with Abdominal Hysterectomy (& Wertheim), run by The Cleveland Clinic at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This study is being done to determine if combined infusions of lidocaine and ketamine is better than a lidocaine or ketamine infusion alone, or to placebo in improving recovery after abdominal hysterectomy. Participants will be randomized into one of four groups. Read more about this study

Who is it for?: Ages 18 to 75 years, women only
Conditions the study is for: Abdominal Hysterectomy (& Wertheim)
What is being tested?: Lidocaine, Ketamine and Ketamine + Lidocaine
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 64 participants
Where: 1 siteUnited States
Study dates: Jul 2008to Jul 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 75 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Age greater than 18 years old and less than 75 years years old
Horizontal abdominal incision

Who cannot join

Emergency or urgent procedure
Preexisting chronic pain (at any site) requiring treatment
Contraindication to any study medication (ketamine or lidocaine)
History of significant Axis I psychiatric disease (major depressive disorder, bipolar disorder, schizophrenia, etc.)
Significant hepatic (ALT or AST > 2 times normal) or renal (serum creatinine > 2 mg/dl) impairment
Seizure disorder requiring medication within past 2 years
Planned spinal or epidural anesthesia or analgesia

Trial locations and contacts

1 site in 1 country.

United States1 site

Cleveland Clinic/Hillcrest Hospital
Mayfield Heights, Ohio, 44124

Other trials in United States

About this study

Official title: Effects of Perioperative Lidocaine and Ketamine Infusions on Acute Functional Recovery After Abdominal Hysterectomy

Read the detailed description

Subjects undergoing abdominal hysterectomy surgery are randomized into one of four groups: Intravenous Lidocaine, Intravenous Ketamine, Intravenous Lidocaine and Ketamine or Placebo. Subjects will perform a six-minute walk test prior to surgery and on the second day postoperatively. After surgery and on days 1 and 2 after surgery, subjects will rate their pain. On day 1 postoperatively, subjects will rate their fatigue. On postoperative days 1 and 2 incisional pain will be analysed using von Frey filaments. Two hours after surgery, 10 ml of venous blood will be sampled for cytokine analysis. Telephone follow up will take place 6 and 12 months postoperatively to access pain and quality of life.

Conditions: Abdominal Hysterectomy (& Wertheim)
Being tested: Lidocaine, Placebo, Ketamine, Ketamine + Lidocaine
Keywords: pain control, nausea, surgery recovery
Medical subject headings: Agnosia, Nausea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LidocaineDrug
Upon general anesthesia induction, lidocaine (1.5 mg/kg) will be given. Lidocaine infusion of 2 mg/kg/hour, to a maximum of 200 mg/hour during The lidocaine infusion will be reduced to 1.3 mg/kg/hour, to a maximum of 133 mg/hour, at skin closure and discontinued 24 hours postoperatively.
PlaceboDrug
Placebo boluses and infusions will be substituted
KetamineDrug
Ketamine (0.25 mg/kg) will be given followed by an infusion of ketamine (0.25 mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively.
Ketamine + LidocaineDrug
both Ketamine and Lidocaine will be given

Study groups in NCT00721110
Study group	Role	What they receive
Lidocaine	Active comparator	Intravenous Lidocaine Group - Lidocaine is administered intravenously throughout surgery and during the 24 hours following surgery Receives: Drug: Lidocaine
Placebo	Placebo comparator	A lidocaine placebo is administered intravenously throughout surgery and during the 24 hours after surgery. Receives: Drug: Placebo
Ketamine	Active comparator	Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery Receives: Drug: Ketamine
ketamine + Lidocaine	Active comparator	both ketamine and Lidocaine are administered intravenously throughout surgery and during the 24 hours after surgery. Receives: Drug: Ketamine + Lidocaine

What is being measured

The primary outcome is the main question the study is designed to answer.

The Effects of Lidocaine and Ketamine on Functional Recovery Assessed by 6 Minute Walk Test on Postoperative Day Two
The effects of lidocaine and ketamine on functional recovery assessed by 6 minute walk test on postoperative day two after hysterectomy. This outcome measures return to ambulation after surgery.
Measured: postoperative day 2

Secondary outcomes (4)

Verbal Response Pain Scores (VRS) at PACU Admission and Discharge as Well as Mornings and Afternoons of Postoperative Days 1 and 2
Verbal response pain scores (VRS) at PACU admission and discharge as well as mornings and afternoons of postoperative days 1 and 2. VRS scale ranges from 0 to 10, with 0 denoting no pain and 10 denoting worst possible pain.
Measured: PACU admission and discharge, postoperative mornings and afternoons on days 1 and 2
Total Opioid Consumption at PACU Admission and Discharge as Well as Mornings of Postoperative Days 1 and 2
Measured: intraoperative through postoperative day 2
Presence of Nausea and Vomiting After Two Hours in the PACU and the First Postoperative Day
Measured: 2 hours after surgery, on postoperative day 1
Verbal Response Fatigue Score on Postoperative Day 1
Verbal response fatigue score on postoperative day 1. Verbal response fatigue score measured on a scale ranging from 0 to 10, where 0 is no fatigue and 10 is the worst possible fatigue.
Measured: postoperative day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2008Jul 2012

First posted23 Jul 2008 (estimated)
Study startJul 2008
Primary completionOct 2010
Study completionJul 2012

Why it stopped: Futility

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Abdominal Hysterectomy (& Wertheim)Studies of the same condition, open and under way.
More trials run by The Cleveland ClinicThe 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: Randomised
Intervention model: Factorial
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00721110
Sponsor's protocol ID: 08-454
Status last verified: Apr 2017
First submitted: 21 Jul 2008
Last updated: 26 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Perioperative Lidocaine and Ketamine Infusions on Acute Functional Recovery After Abdominal Hysterectomy
ClinicalTrials.gov ID: NCT00721110
Acronym / sponsor ID: 08-454
Conditions: Abdominal Hysterectomy (& Wertheim)
Keywords: pain control, nausea, surgery recovery
Study type: Interventional
Recruitment status: TerminatedReason stopped: Futility
Enrolment: 64 participants (actual)
Lead sponsor: The Cleveland ClinicUniversity, hospital or other
Study start: Jul 2008
Primary completion: Oct 2010 (actual)
Study completion: Jul 2012 (actual)
First posted: 23 Jul 2008 (estimated)
Results: Posted 26 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Lidocaine	Active comparator	Drug: LidocaineIntravenous Lidocaine Group - Lidocaine is administered intravenously throughout surgery and during the 24 hours following surgery
Placebo	Placebo comparator	Drug: PlaceboA lidocaine placebo is administered intravenously throughout surgery and during the 24 hours after surgery.
Ketamine	Active comparator	Drug: KetamineIntravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery
ketamine + Lidocaine	Active comparator	Drug: Ketamine + Lidocaineboth ketamine and Lidocaine are administered intravenously throughout surgery and during the 24 hours after surgery.

Who may qualify

Ages: 18 to 75 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Age greater than 18 years old and less than 75 years years old
Horizontal abdominal incision

Key exclusion criteria (7 listed)

Emergency or urgent procedure
Preexisting chronic pain (at any site) requiring treatment
Contraindication to any study medication (ketamine or lidocaine)
History of significant Axis I psychiatric disease (major depressive disorder, bipolar disorder, schizophrenia, etc.)
Significant hepatic (ALT or AST > 2 times normal) or renal (serum creatinine > 2 mg/dl) impairment

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
LidocaineUpon general anesthesia induction, lidocaine (1.5 mg/kg) will be given. Lidocaine infusion of 2 mg/kg/hour, to a maximum of 200 mg/hour during The lidocaine infusion will be reduced to 1.3 mg/kg/hour, to a maximum of 133 mg/hour, at skin closure and discontinued 24 hours postoperatively.	Drug	Lidocaine
PlaceboPlacebo boluses and infusions will be substituted	Drug	Placebo
KetamineKetamine (0.25 mg/kg) will be given followed by an infusion of ketamine (0.25 mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively.	Drug	Ketamine
Ketamine + Lidocaineboth Ketamine and Lidocaine will be given	Drug	ketamine + Lidocaine

Primary outcome

The Effects of Lidocaine and Ketamine on Functional Recovery Assessed by 6 Minute Walk Test on Postoperative Day Two
Time frame: postoperative day 2
The effects of lidocaine and ketamine on functional recovery assessed by 6 minute walk test on postoperative day two after hysterectomy. This outcome measures return to ambulation after surgery.

4 secondary outcomes

Verbal Response Pain Scores (VRS) at PACU Admission and Discharge as Well as Mornings and Afternoons of Postoperative Days 1 and 2
Time frame: PACU admission and discharge, postoperative mornings and afternoons on days 1 and 2
Total Opioid Consumption at PACU Admission and Discharge as Well as Mornings of Postoperative Days 1 and 2
Time frame: intraoperative through postoperative day 2
Presence of Nausea and Vomiting After Two Hours in the PACU and the First Postoperative Day
Time frame: 2 hours after surgery, on postoperative day 1
Verbal Response Fatigue Score on Postoperative Day 1
Time frame: postoperative day 1

Results and safety

Results posted to the registry on 26 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lidocaine/Ketamine	16	15
Lidocaine	16	16
Ketamine	16	15
Placebo	16	16

Primary outcome: The Effects of Lidocaine and Ketamine on Functional Recovery Assessed by 6 Minute Walk Test on Postoperative Day Two

Time frame: postoperative day 2. Mean (Standard Deviation). Unit: meters

Measure	Lidocaine n = 31	Nonlidocaine n = 31	Ketamine n = 30	Nonketamine n = 32
Value	202 (66)	202 (73)	193 (77)	210 (61)

Lidocaine vs Nonlidocaine: Mean Difference (Final Values): 0.93 (97.5% CI -52 to 54), p = 0.96, ANCOVA
Ketamine vs Nonketamine: Mean Difference (Final Values): -11 (97.5% CI -65 to 44), p = 0.54, ANCOVA

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lidocaine	0 of 16 (0%)	0 of 16 (0%)	16 of 16
Placebo	0 of 16 (0%)	0 of 16 (0%)	16 of 16
Ketamine	0 of 15 (0%)	0 of 15 (0%)	15 of 15
Ketamine + Lidocaine	0 of 15 (0%)	0 of 15 (0%)	15 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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.

Martin Grady, MD principal investigator

The Cleveland Clinic

Daniel I Sessler, MD study chair

The Cleveland Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Lidocaine, Ketamine and Ketamine + Lidocaine in people with Abdominal Hysterectomy (& Wertheim), run by The Cleveland Clinic at 1 site in United States.

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 2 inclusion and 7 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: stopped early, as of the sponsor's last update on 26 Jul 2017. 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 United States. 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?

Yes. Results are posted in the registry (first posted 26 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Effects of Lidocaine and Ketamine on Functional Recovery Assessed by 6 Minute Walk Test on Postoperative Day Two (time frame: postoperative day 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00721110.

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 Jul 2017.