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Perioperative Epidural Versus Intravenous Local Anesthetic Infusion in Open Upper Abdominal Surgery

Perioperative Epidural Versus Intravenous Local Anesthetic Infusion in Open Upper Abdominal Surgery

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03005171
Enrollment
70
Registered
2016-12-29
Start date
2017-01-31
Completion date
2017-08-31
Last updated
2017-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain

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.

Interventions

DRUGBupivacaine

Thoracic epidural bupivacaine infusion

DRUGLidocaine

Intravenous lidocaine infusion

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Patients undergoing open upper abdominal surgery

Exclusion criteria

* Bleeding diathesis * History of allergy to local anesthetics * Pregnancy/ lactation * Cardiovascular disease * Respiratory disease

Design outcomes

Primary

MeasureTime frameDescription
Verbal Numeric Rating Score2-24 hoursVerbal Numeric Rating Score is an 11-point scoring system used to assesses the postoperative pain level of the participants

Secondary

MeasureTime frameDescription
B- endorphin levelBaseline-24 hoursA measure for postoperative pain response compared to the baseline values
FVCBaseline-24 hoursForced Vital Capacity
FEV1Baseline-24 hoursForced Expiratory Volume

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026