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Gynecologic CancerEarly Phase 1NCT03658109

Lidocaine Infusion or Quadratus Lumborum Block and Intrathecal Morphine, Versus Intrathecal Morphine Alone

A Early Phase 1 study testing Lidocaine Bolus Infusion, QL block and Saline Bolus Infusion in people with Gynecologic Cancer, run by University of Alabama at Birmingham 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 may provide evidence for whether or not systemic lidocaine infusion offers significant advantage over truncal regional blocks in gynecology oncology surgery patients in terms of post-operative analgesia, recovery, and safety profile. Read more about this study

Who is it for?
Ages 18 to 69 years, women onlyHealthy volunteers can take part
Conditions the study is for
Gynecologic Cancer
What is being tested?
Lidocaine Bolus Infusion, QL block and Saline Bolus Infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteUnited States
Study dates
24 Sep 2019to 4 May 2021
Phase
Early Phase 1
Are there results?
None posted in the registry

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 69 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adult patients undergoing gynecologic-oncology surgery involving a mid-line laparotomy incision and as part of the local ERP, who are initially identified as an outpatient
  • 18 years of age or older

Who cannot join

  • Pregnancy,
  • BMI>45,
  • Age >70,
  • Actual weight <65 kg
  • Severe COPD
  • Severe asthma
Show all 12Show fewer
  • Other severe respiratory disease (ILD, etc.)
  • Local anesthetic allergy
  • History of cardiac arrhythmia or heart block
  • CHF
  • Use of oral anti-arrhythmia agents or lidocaine analogues (i.e. mexiletine)
  • Inability to be a candidate for intrathecal opioid injection based on medical history and provider judgement

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

Other trials in United States

About this study

Official title: Systemic Lidocaine Infusion or Quadratus Lumborum Block (in Addition to Intrathecal Morphine) Versus Intrathecal Morphine Alone as Part of a Gynecology-Oncology Surgery Early Recovery Protocol

This study may provide evidence for whether or not systemic lidocaine infusion offers significant advantage over truncal regional blocks in gynecology oncology surgery patients in terms of post-operative analgesia, recovery, and safety profile. Further, it may show whether there is any increased efficacy of adding truncal regional block or systemic lidocaine versus intrathecal opioid administration alone.

Read the detailed description

Systemic administration of intravenous lidocaine has a number of observed and theoretical advantages in the perioperative period. Systematic review of perioperative lidocaine infusions has shown a reduction in early post-operative pain scores in patients undergoing abdominal surgery, positive effects for GI recovery, reduction in post-operative opioid requirements, reduction in the incidence of post-operative nausea and vomiting, and decreased length of hospital stay. They have been shown to modulate the surgery-induced stress response in colorectal surgery and abdominal hysterectomy. Thoracic epidural analgesia was better as compared to intravenous lidocaine in a RCT of patients undergoing laparoscopic colorectal surgery as part of an enhanced recovery program, though there was similar impact on recovery of bowel function.

Truncal regional anesthesia has been utilized in open and closed abdominal operations with various levels of efficacy. A statistically significant, though marginal clinical analgesic benefit, by recorded opioid consumption, has been concluded by meta-analysis in patients undergoing abdominal laparotomy, laparoscopy, or cesarean delivery after US-guided TAP block. There was not found to be any additional benefit of TAP block in patients who received a spinal anesthetic that included a long-acting opioid. The interpretation of results was noted to be limited by the heterogeneity of the included studies and analysis, though. The conclusions of one study of open prostatectomy, as part of an ERP, was that neither systemic lidocaine nor TAP block improved post-operative analgesia. Both IV lidocaine and TAP block groups showed a reduction in post-operative opioid consumption, though to an insignificant degree. It was noted as a possibility that the other interventions as part of the ERP, such as scheduled administration of IV acetaminophen, could have resulted in the non-significant decrease in post-operative opioid requirement. A recent review of the use of TAP blocks in major gynecological, non-obstetric, surgery, including total abdominal hysterectomy, concluded that TAP blocks may contribute to early post-operative analgesia, with marginal additional benefit if multimodal analgesic regimens including NSAIDs and acetaminophen are added. It was hypothesized by the authors that some of the limited benefit might be due to the fact that US-guided TAP blocks are primarily useful for somatic pain, but that major gynecologic surgery has a large visceral pain component. There are limited randomized studies involving Quadratus Lumborum block (QL) at this time. QL block has shown improved analgesia in abdominal operations as compared to TAP block and is thought to have potentially greater relief of visceral pain. There is a case report of motor weakness following anterior, lateral QL block for gynecologic laparoscopy, thought to be related to spread of the block to affect the L2 dermatome on one side. It has not been determined if this is a common occurrence or may be affected by the type of QL block performed.

Prior to this study, truncal regional anesthesia was used in the UAB Gynecology-Oncology Surgery Enhanced Recovery Program as an analgesic alternative for those who were not good candidates for intrathecal opioid injection. A comparison of QL block versus systemic lidocaine infusion or whether either of these interventions has utility over intrathecal opioid administration alone has yet to be described.

Being tested
Lidocaine Bolus Infusion, QL block, Saline Bolus Infusion, Simulated QL block

What participants receive

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

  • Lidocaine Bolus InfusionDrug

    Also called Systemic Lidocaine Bolus Infusion

    Patients will undergo Lidocaine Bolus infusion.

  • QL blockProcedure or surgery

    Also called Posterior QL block

    Patients will undergo a posterior QL block pre-operatively

  • Saline Bolus InfusionDrug

    Also called Placebo Saline Bolus Infusion

    Patients will undergo Saline Bolus infusion.

  • Simulated QL blockProcedure or surgery

    Also called Simulated posterior QL block pre-operatively

    Patients will undergo a simulated posterior QL block pre-operatively.

Study groups in NCT03658109
Study groupRoleWhat they receive
Lidocaine Bolus InfusionActive comparatorPatients will also undergo a loading dose of lidocaine, followed by continuous lidocaine infusion in the lidocaine group. Patients will undergo an injection of intrathecal opioid medication (morphine) preoperatively. Patients will undergo a simulated QL block.
Receives: Drug: Lidocaine Bolus Infusion; Drug: Saline Bolus Infusion; Procedure: Simulated QL block
QL Block & Saline Bolus InfusionActive comparatorPatients will undergo a posterior QL block. Patients will undergo an injection of intrathecal opioid medication (morphine) preoperatively. Patients will receive a saline bolus infusion.
Receives: Procedure: QL block
Intrathecal Morphine AloneNo interventionPatients will undergo an injection of intrathecal opioid medication (morphine) preoperatively. Patients will undergo a simulated QL block. Patients will receive a saline bolus infusion.

What is being measured

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

  1. PACU Post-operative opioid consumption

    Total opioid consumption (measured in oral morphine equivalents)

    Measured: From 0 to 12 hours post surgery

Secondary outcomes (12)
  1. Length of PACU admittance to time of readiness for discharge from PACU

    This outcome measure will reflect the total amount of time required for the patient to be deemed suitable for discharge from the PACU, starting from the time of admittance to the PACU.

    Measured: Time of PACU admittance to the time of PACU readiness for discharge, generally not more than 12 hours

  2. PACU Sedation Scores

    This score will be collected using the modified Aldrete scale, every 15 minutes for the first hour of PACU stay, and once per hour for any additional hour(s) of PACU stay using a method consisting of: Consciousness = fully awake (2 points), arousable (1 point), not responding (0 points). This scale is used to determine a participant's state of arousal. The range of the scale is from 0-2, with zero being the most unresponsive and two being the most responsive.

    Measured: From 0 to 12 hours post surgery

  3. Length of hospital stay

    Measured: Time of admission until time of discharge, generally not over 1 week

  4. Ambulation on POD 0 and POD1

    Number of minutes spent ambulating, per subject and/or nurse reporting

    Measured: From 0 to 96 hours post surgery

  5. Return to bowel function

    Return to bowel function (return of flatus, BM, ability to tolerate PO), per subject and/or nurse reporting

    Measured: From 0 to 96 hours post surgery

  6. Total Opioid Dose Utilized During Surgery

    likely expressed as mcg of fentanyl but may be converted to morphine equivalent dose if multiple opioids are used

    Measured: From one hour before surgery start time to one hour after procedure stop time

  7. Presence or Absence of Patient Controlled Analgesia

    Whether or not a PCA is needed for post-operative analgesia (Y/N - per usual documentation in the EMR.

    Measured: From 0 to 96 hours post surgery

  8. Time to First Opioid Use

    time from admission to the floor to administration of first opioid medication (per usual nursing documentation in the EMR).

    Measured: From 0 to 96 hours post surgery

  9. Average PACU Pain Score

    This outcome will be measured by taking the average of the numerical pain scale used to assess a patient's pain levels throughout their time in the PACU. The numerical pain scale has a range of 0 to 10, with 0 being no pain and 10 being very severe pain.

    Measured: From 0 to 12 hours post surgery

  10. Post Operative Pain Scores

    This outcome will be measured by taking the value of the numerical pain scale used to assess a patient's pain levels throughout their time in the hospital that is closest to each 4 hours after the time of the anesthesia documentation finish

    Measured: From 0 to 72 hours post surgery

  11. Average PACU opioid consumption

    Average total amount of opioids consumed in the PACU

    Measured: From 0 to 12 hours post surgery

  12. Post-operative opioid consumption

    Post-operative opioid consumption (measured in oral morphine equivalents)

    Measured: From 0 to 72 hours post surgery

Timeline

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

  1. First posted5 Sep 2018
  2. Study start24 Sep 2019
  3. Primary completion4 May 2021
  4. Study completion4 May 2021

Why it stopped: Recruitment challenges due to COVID-19

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03658109
Sponsor's protocol ID
56789013
Status last verified
May 2021
First submitted
13 Aug 2018
Last updated
10 May 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Lidocaine Bolus Infusion, QL block and Saline Bolus Infusion in people with Gynecologic Cancer, run by University of Alabama at Birmingham 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 12 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 10 May 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Recruitment challenges due to COVID-19). Results are not available in the source record.

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?

PACU Post-operative opioid consumption (time frame: From 0 to 12 hours post surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 10 May 2021.

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