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

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.

Study Overview

• Status: Terminated
• Conditions: Gynecologic Cancer
• Intervention / Treatment: Drug: Lidocaine Bolus Infusion; Drug: Saline Bolus Infusion; Procedure: Simulated QL block; Procedure: QL block

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 Type: Interventional
• Enrollment (Actual): 1
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Pregnancy,
• BMI>45,
• Age >70,
• Actual weight <65 kg
• Severe COPD
• Severe asthma
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lidocaine Bolus Infusion; 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.	Drug: Lidocaine Bolus Infusion; Patients will undergo Lidocaine Bolus infusion.; Other Names: Systemic Lidocaine Bolus Infusion; Drug: Saline Bolus Infusion; Patients will undergo Saline Bolus infusion.; Other Names: Placebo Saline Bolus Infusion; Procedure: Simulated QL block; Patients will undergo a simulated posterior QL block pre-operatively.; Other Names: Simulated posterior QL block pre-operatively
Active Comparator: QL Block & Saline Bolus Infusion; 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.	Procedure: QL block; Patients will undergo a posterior QL block pre-operatively; Other Names: Posterior QL block
No Intervention: Intrathecal Morphine Alone; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PACU Post-operative opioid consumption	Total opioid consumption (measured in oral morphine equivalents)	From 0 to 12 hours post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	From 0 to 12 hours post surgery
Length of hospital stay		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	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	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	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.	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).	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.	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	From 0 to 72 hours post surgery
Average PACU opioid consumption	Average total amount of opioids consumed in the PACU	From 0 to 12 hours post surgery
Post-operative opioid consumption	Post-operative opioid consumption (measured in oral morphine equivalents)	From 0 to 72 hours post surgery

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Prentiss Lawson, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2019
• Primary Completion (Actual): May 4, 2021
• Study Completion (Actual): May 4, 2021

Study Registration Dates

• First Submitted: August 13, 2018
• First Submitted That Met QC Criteria: August 31, 2018
• First Posted (Actual): September 5, 2018

Study Record Updates

• Last Update Posted (Actual): May 10, 2021
• Last Update Submitted That Met QC Criteria: May 5, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 56789013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes