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

NCT03658109 | Terminated Early Phase 1 DMC FDA Drug

• 1 other identifier: 56789013
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Cancer

Outcome Measures

Primary Outcomes (1)

• PACU Post-operative opioid consumption

  Total opioid consumption (measured in oral morphine equivalents)

  From 0 to 12 hours post surgery

Secondary Outcomes (12)

• 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

• PACU Sedation Scores

  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

  From 0 to 96 hours post surgery

• Return to bowel function

  From 0 to 96 hours post surgery

Study Arms (3)

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.

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.

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.

Interventions

Lidocaine Bolus Infusion DRUG

Patients will undergo Lidocaine Bolus infusion.

Also known as: Systemic Lidocaine Bolus Infusion

Lidocaine Bolus Infusion

QL block PROCEDURE

Patients will undergo a posterior QL block pre-operatively

Also known as: Posterior QL block

QL Block & Saline Bolus Infusion

Saline Bolus Infusion DRUG

Patients will undergo Saline Bolus infusion.

Also known as: Placebo Saline Bolus Infusion

Lidocaine Bolus Infusion

Simulated QL block PROCEDURE

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

Also known as: Simulated posterior QL block pre-operatively

Lidocaine Bolus Infusion

Eligibility Criteria

• Age: 18 Years - 69 Years
• Gender Eligibility Details: Participant eligibility is based on biological gender identity.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Study Officials

• Prentiss Lawson, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Eligible patients will undergo current standard enhanced recovery protocol (ERP) gyn-oncology protocol. All patients will receive intrathecal morphine as part of the existing ERP. They will then be randomized to receive; either lidocaine infusion, regional anesthesia truncal block (quadratus lumborum block), or intrathecal morphine alone. Patients will be randomized into either lidocaine (group 1), QL block (group 2), or intrathecal opioid alone (group 3) groups. There will be blinding of the patient and personnel involved in data collection, and patients will undergo either a posterior QL block with local anesthetic (group 2) or simulated QL block (groups 1 and 3; subcutaneous local anesthetic only) pre-operatively. All patients will also undergo a loading dose of lidocaine (groups 1) or saline (group 2 and 3) followed by continuous lidocaine infusion in the lidocaine group (group 1). Primary and secondary endpoints will be measured post-operatively.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: September 5, 2018
• Study Start: September 24, 2019
• Primary Completion: May 4, 2021
• Study Completion: May 4, 2021
• Last Updated: May 10, 2021

Record last verified: 2021-05

Locations

US (1)