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.
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
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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
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.
- Conditions
- Gynecologic Cancer
- 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 group | Role | What they receive |
|---|---|---|
| Lidocaine Bolus Infusion | Active comparator | Patients 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 Infusion | Active comparator | Patients 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 Alone | No intervention | Patients 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.
PACU Post-operative opioid consumption
Total opioid consumption (measured in oral morphine equivalents)
Measured: From 0 to 12 hours post surgery
Secondary outcomes (12)
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
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
Length of hospital stay
Measured: Time of admission until time of discharge, generally not over 1 week
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
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
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
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
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
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
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
Average PACU opioid consumption
Average total amount of opioids consumed in the PACU
Measured: From 0 to 12 hours post surgery
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.
- First posted5 Sep 2018
- Study start24 Sep 2019
- Primary completion4 May 2021
- Study completion4 May 2021
Why it stopped: Recruitment challenges due to COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- 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)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prentiss Lawson, University of Alabama at Birmingham
- Investigators
- Prentiss Lawson, MD, Principal investigator, University of Alabama at Birmingham
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
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03658109
- Acronym / sponsor ID
- 56789013
- Conditions
- Gynecologic Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment challenges due to COVID-19
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 4 May 2021 (actual)
- Study completion
- 4 May 2021 (actual)
- First posted
- 5 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lidocaine Bolus Infusion | Active comparator | Drug: Lidocaine Bolus Infusion, Drug: Saline Bolus Infusion, Procedure: Simulated QL blockPatients 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. |
| QL Block & Saline Bolus Infusion | Active comparator | Procedure: QL blockPatients will undergo a posterior QL block. Patients will undergo an injection of intrathecal opioid medication (morphine) preoperatively. Patients will receive a saline bolus infusion. |
| Intrathecal Morphine Alone | No intervention | –Patients will undergo an injection of intrathecal opioid medication (morphine) preoperatively. Patients will undergo a simulated QL block. Patients will receive a saline bolus infusion. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (12 listed)
- Pregnancy,
- BMI>45,
- Age >70,
- Actual weight <65 kg
- Severe COPD
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 |
|---|---|---|
| Lidocaine Bolus InfusionAlso: Systemic Lidocaine Bolus InfusionPatients will undergo Lidocaine Bolus infusion. | Drug | Lidocaine Bolus Infusion |
| QL blockAlso: Posterior QL blockPatients will undergo a posterior QL block pre-operatively | Procedure or surgery | QL Block & Saline Bolus Infusion |
| Saline Bolus InfusionAlso: Placebo Saline Bolus InfusionPatients will undergo Saline Bolus infusion. | Drug | Lidocaine Bolus Infusion |
| Simulated QL blockAlso: Simulated posterior QL block pre-operativelyPatients will undergo a simulated posterior QL block pre-operatively. | Procedure or surgery | Lidocaine Bolus Infusion |
Primary outcome
PACU Post-operative opioid consumption
Time frame: From 0 to 12 hours post surgery
Total opioid consumption (measured in oral morphine equivalents)
12 secondary outcomes
Length of PACU admittance to time of readiness for discharge from PACU
Time frame: Time of PACU admittance to the time of PACU readiness for discharge, generally not more than 12 hours
PACU Sedation Scores
Time frame: From 0 to 12 hours post surgery
Length of hospital stay
Time frame: Time of admission until time of discharge, generally not over 1 week
Ambulation on POD 0 and POD1
Time frame: From 0 to 96 hours post surgery
Return to bowel function
Time frame: From 0 to 96 hours post surgery
Total Opioid Dose Utilized During Surgery
Time frame: From one hour before surgery start time to one hour after procedure stop time
Presence or Absence of Patient Controlled Analgesia
Time frame: From 0 to 96 hours post surgery
Time to First Opioid Use
Time frame: From 0 to 96 hours post surgery
Average PACU Pain Score
Time frame: From 0 to 12 hours post surgery
Post Operative Pain Scores
Time frame: From 0 to 72 hours post surgery
Average PACU opioid consumption
Time frame: From 0 to 12 hours post surgery
Post-operative opioid consumption
Time frame: From 0 to 72 hours post surgery
Results and safety
The study was stopped early (reason given: Recruitment challenges due to COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
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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.
Prentiss Lawson, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
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.