Perioperative Epidural Versus Intravenous Local Anesthetic Infusion in Open Upper Abdominal Surgery
Primary Purpose
Acute Pain
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Bupivacaine
Lidocaine
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing open upper abdominal surgery
Exclusion Criteria:
- Bleeding diathesis
- History of allergy to local anesthetics
- Pregnancy/ lactation
- Cardiovascular disease
- Respiratory disease
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Epidural
Lidocaine
Arm Description
Epidural catheters will be placed in the 9th or 10th thoracic intervertebral space prior to induction of anesthesia.Through the thoracic epidural catheter 0.125% bupivacaine at a rate of 5 mL/h will be infused. The infusion continues for 24h
Intravenous lidocaine infusion will typically start in the operating room prior to induction of anesthesia at a rate of 2 to 3 mg/min. Postoperatively, the rate will be decreased to 0.5 to 1 mg/min. The infusion continues for 24h
Outcomes
Primary Outcome Measures
Verbal Numeric Rating Score
Verbal Numeric Rating Score is an 11-point scoring system used to assesses the postoperative pain level of the participants
Secondary Outcome Measures
B- endorphin level
A measure for postoperative pain response compared to the baseline values
FVC
Forced Vital Capacity
FEV1
Forced Expiratory Volume
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03005171
Brief Title
Perioperative Epidural Versus Intravenous Local Anesthetic Infusion in Open Upper Abdominal Surgery
Official Title
Perioperative Epidural Versus Intravenous Local Anesthetic Infusion in Open Upper Abdominal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
January 2017 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study evaluates the efficacy of intravenous lidocaine as an analgesic modality in patients undergoing open upper abdominal surgery; when compared with thoracic epidural analgesia. Half of participants will receive intravenous lidocaine infusion, while the other half will receive thoracic epidural bupivacaine infusion.
Detailed Description
Postoperative pain is one of the commonest problems encountered by anaesthesiologists, especially after open abdominal surgeries, in which post-operative pain would cause a restrictive respiratory dysfunction, which is associated with poor postoperative outcomes. Despite the fact that epidural blocks provide superior analgesia; it is not often an ideal option as it frequently causes hypotension that may require excessive intravenous fluid administration, which is particularly deleterious after bowel surgery. Other complications include epidural hematoma and higher failure rate. Furthermore epidural analgesia may be contraindicated in some patients e.g. patients on certain anti-platelet therapy and patients refusing the technique.
Other modalities to control postoperative pain are used e.g. intravenous analgesics and continuous wound infiltration, but none of which was proven to be as effective as epidural block.
Whether perioperative lidocaine infusion is as effective as epidural block in reducing post-operative pain, is this study's concern.
Some researches studied the efficacy of lidocaine infusion in controlling neuropathic as well as acute postoperative pain with encouraging results. Lidocaine infusion was found to reduce postoperative pain, opioid consumption and the length of hospital stay. Although risks of neurological and cardiac toxicity exist, these were not substantiated in the trials.
Lidocaine has been described to have both analgesic, and anti-hyperalgesic effects6, as well as anti-inflammatory properties. It also accelerates the return of post-operative gastrointestinal function, which is of particular importance after major abdominal surgery. Opposite to opioids, which increase the incidence of nausea and vomiting, lidocaine decreases their incidence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Epidural
Arm Type
Active Comparator
Arm Description
Epidural catheters will be placed in the 9th or 10th thoracic intervertebral space prior to induction of anesthesia.Through the thoracic epidural catheter 0.125% bupivacaine at a rate of 5 mL/h will be infused.
The infusion continues for 24h
Arm Title
Lidocaine
Arm Type
Active Comparator
Arm Description
Intravenous lidocaine infusion will typically start in the operating room prior to induction of anesthesia at a rate of 2 to 3 mg/min. Postoperatively, the rate will be decreased to 0.5 to 1 mg/min.
The infusion continues for 24h
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcaine
Intervention Description
Thoracic epidural bupivacaine infusion
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
Xylocaine, Lidocaine Hydrochloride
Intervention Description
Intravenous lidocaine infusion
Primary Outcome Measure Information:
Title
Verbal Numeric Rating Score
Description
Verbal Numeric Rating Score is an 11-point scoring system used to assesses the postoperative pain level of the participants
Time Frame
2-24 hours
Secondary Outcome Measure Information:
Title
B- endorphin level
Description
A measure for postoperative pain response compared to the baseline values
Time Frame
Baseline-24 hours
Title
FVC
Description
Forced Vital Capacity
Time Frame
Baseline-24 hours
Title
FEV1
Description
Forced Expiratory Volume
Time Frame
Baseline-24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing open upper abdominal surgery
Exclusion Criteria:
Bleeding diathesis
History of allergy to local anesthetics
Pregnancy/ lactation
Cardiovascular disease
Respiratory disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Assiut University
Organizational Affiliation
Assiut University, Egypt
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Perioperative Epidural Versus Intravenous Local Anesthetic Infusion in Open Upper Abdominal Surgery
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