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

NCT ID: NCT03658109

Last Updated: 2021-05-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-24
• Study Completion Date: 2021-05-04

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.

Conditions

Gynecologic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Lidocaine Bolus Infusion

Intervention Type: DRUG

Patients will undergo Lidocaine Bolus infusion.

Saline Bolus Infusion

Intervention Type: DRUG

Patients will undergo Saline Bolus infusion.

Simulated QL block

Intervention Type: PROCEDURE

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

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.

Group Type: ACTIVE_COMPARATOR

QL block

Intervention Type: PROCEDURE

Patients will undergo a posterior QL block pre-operatively

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lidocaine Bolus Infusion

Patients will undergo Lidocaine Bolus infusion.

Intervention Type: DRUG

QL block

Patients will undergo a posterior QL block pre-operatively

Intervention Type: PROCEDURE

Saline Bolus Infusion

Patients will undergo Saline Bolus infusion.

Intervention Type: DRUG

Simulated QL block

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

Intervention Type: PROCEDURE

Other Intervention Names

Systemic Lidocaine Bolus Infusion; Posterior QL block; Placebo Saline Bolus Infusion; Simulated posterior QL block pre-operatively

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Prentiss Lawson

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Prentiss Lawson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

56789013

Identifier Type: -

Identifier Source: org_study_id