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

Early Phase 1

Terminated

• Conditions: Gynecologic Cancer
• Interventions: Drug: Lidocaine Bolus Infusion; Procedure: QL block; Drug: Saline Bolus Infusion; Procedure: Simulated QL block

• Registration Number: NCT03658109
• Lead Sponsor: University of Alabama at Birmingham

Brief 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. 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 Timeline

• Study First Submitted: 2018-08-13
• Study First Submitted QC: 2018-08-31
• Study First Posted: 2018-09-05
• Study Start: 2019-09-24
• Status Verified: 2021-05
• Primary Completion: 2021-05-04
• Study Completion: 2021-05-04
• Last Update Submitted: 2021-05-05
• Last Update Posted: 2021-05-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 1

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine Bolus Infusion	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.
Lidocaine Bolus Infusion	Saline 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.
Lidocaine Bolus Infusion	Simulated QL block	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.
QL Block & Saline Bolus Infusion	QL block	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.

Primary Outcome Measures

Name	Time	Method
PACU Post-operative opioid consumption	From 0 to 12 hours post surgery	Total opioid consumption (measured in oral morphine equivalents)

Secondary Outcome Measures

Name	Time	Method
Length of PACU admittance to time of readiness for discharge from PACU	Time of PACU admittance to the time of PACU readiness for discharge, generally not more than 12 hours	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.
PACU Sedation Scores	From 0 to 12 hours post surgery	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.
Length of hospital stay	Time of admission until time of discharge, generally not over 1 week
Ambulation on POD 0 and POD1	From 0 to 96 hours post surgery	Number of minutes spent ambulating, per subject and/or nurse reporting
Return to bowel function	From 0 to 96 hours post surgery	Return to bowel function (return of flatus, BM, ability to tolerate PO), per subject and/or nurse reporting
Total Opioid Dose Utilized During Surgery	From one hour before surgery start time to one hour after procedure stop time	likely expressed as mcg of fentanyl but may be converted to morphine equivalent dose if multiple opioids are used
Presence or Absence of Patient Controlled Analgesia	From 0 to 96 hours post surgery	Whether or not a PCA is needed for post-operative analgesia (Y/N - per usual documentation in the EMR.
Time to First Opioid Use	From 0 to 96 hours post surgery	time from admission to the floor to administration of first opioid medication (per usual nursing documentation in the EMR).
Average PACU Pain Score	From 0 to 12 hours post surgery	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.
Post Operative Pain Scores	From 0 to 72 hours post surgery	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
Average PACU opioid consumption	From 0 to 12 hours post surgery	Average total amount of opioids consumed in the PACU
Post-operative opioid consumption	From 0 to 72 hours post surgery	Post-operative opioid consumption (measured in oral morphine equivalents)

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States