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

NCT ID: NCT03005171

Last Updated: 2017-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-08-31

Brief Summary

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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

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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.

Conditions

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Acute Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Epidural

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

Group Type ACTIVE_COMPARATOR

Bupivacaine

Intervention Type DRUG

Thoracic epidural bupivacaine infusion

Lidocaine

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

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

Intravenous lidocaine infusion

Interventions

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Bupivacaine

Thoracic epidural bupivacaine infusion

Intervention Type DRUG

Lidocaine

Intravenous lidocaine infusion

Intervention Type DRUG

Other Intervention Names

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Marcaine Xylocaine Lidocaine Hydrochloride

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing open upper abdominal surgery

Exclusion Criteria

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

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Asmaa Mohamed Moatasem

Assistant Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Assiut University

Role: STUDY_DIRECTOR

Assiut University, Egypt

Other Identifiers

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IRB00008718/1438

Identifier Type: -

Identifier Source: org_study_id