Efficacy of Intraperitoneal Versus Intravenous Lidocaine for Postcesarean Pain Relief
NCT ID: NCT02707081
Last Updated: 2016-03-14
Study Results
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Basic Information
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COMPLETED
PHASE2/PHASE3
150 participants
INTERVENTIONAL
2013-06-30
2015-12-31
Brief Summary
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Study design: prospective randomized, double-blind, placebo-controlled study. Patients and methods: Initially, 165 pregnant full-term females, indicated to be underwent elective cesarean delivery for various indications were randomized equally to either group C (control, IP and IV saline), group IP (intraperitoneal lidocaine administration), or group IV (intravenous lidocaine infusion).Five patients were excluded from each group for various reasons. The outcome measures were postoperative pain scoring, total pethidine consumption and the need for postoperative analgesia.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo control group
Saline was given both intraperitoneally and intravenously during caesarean section
Intravenous normal saline
Normal saline in a volume equivalent to that used in intravenous lidocaine group
Intraperitoneal normal saline
Patients received 00 ml of saline intraperitoneally
Intraperitoneal instillation group
Patients received 1.75 ml/kg of 0.2% lidocaine (3.5mg/kg) with parietal peritoneal closure with intravenous normal saline in a volume equivalent to that used in intravenous lidocaine group as placebo to ensure blinding.
Intravenous normal saline
Normal saline in a volume equivalent to that used in intravenous lidocaine group
Intraperitoneal Lidocaine
Patients received 1.75 ml/kg of 0.2% lidocaine (3.5mg/kg) with parietal peritoneal closure.
Intravenous injection group
Patients received 1.5mg/kg of intravenous 1% lidocaine as bolus dose at induction and 2mg/kg/hour as continuous infusion of intravenous lidocaine until one hour after surgery and 100 ml of saline intraperitoneally as placebo to ensure blinding
Intraperitoneal normal saline
Patients received 00 ml of saline intraperitoneally
Intravenous Lidocaine
Patients received 1.5mg/kg of intravenous 1% lidocaine as bolus dose at induction and 2mg/kg/hour as continuous infusion of intravenous lidocaine until one hour after surgery.
Interventions
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Intravenous normal saline
Normal saline in a volume equivalent to that used in intravenous lidocaine group
Intraperitoneal normal saline
Patients received 00 ml of saline intraperitoneally
Intraperitoneal Lidocaine
Patients received 1.75 ml/kg of 0.2% lidocaine (3.5mg/kg) with parietal peritoneal closure.
Intravenous Lidocaine
Patients received 1.5mg/kg of intravenous 1% lidocaine as bolus dose at induction and 2mg/kg/hour as continuous infusion of intravenous lidocaine until one hour after surgery.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
40 Years
FEMALE
No
Sponsors
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Benha University
OTHER
Responsible Party
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Ahmed Walid Anwar Murad
Assistant Professor
Other Identifiers
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Benha 121
Identifier Type: -
Identifier Source: org_study_id
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