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Does Intraperitoneal Instillation of Lidocaine at Cesarean Delivery Improve Postoperative Analgesia?

NCT02264795 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2016-05-03

No results posted yet for this study

Summary

The instillation of local anesthetic into the peritoneum has been found to be safe and effective in reducing postoperative pain and morphine consumption after abdominal surgery. A review of studies reporting serum levels of local anesthetic after intraperitoneal delivery found no cases of clinical toxicity in any of the trials. The studies in this meta-analysis did not include post-cesarean delivery pain and there is a lack of data to support the use of intraperitoneal local anesthetic after cesarean section.

The purpose of this study is to assess the efficacy of intraperitoneal lidocaine on postoperative pain scores after cesarean delivery. This study will compare a 20ml solution of lidocaine (400mg) with epinephrine 5mcg/ml versus normal saline (placebo) instilled into the peritoneum at the end of surgery in women undergoing cesarean delivery. The investigators hypothesize that intraperitoneal lidocaine will result in lower pain scores, reduce opioid consumption and opioid related side effects, and higher maternal satisfaction after cesarean delivery.

Conditions

Interventions

DRUG

Lidocaine

Lidocaine 2% with epinephrine 5mcg/ml

DRUG

Placebo

0.9% Sodium Chloride Solution

Sponsors & Collaborators

  • Samuel Lunenfeld Research Institute, Mount Sinai Hospital

    lead OTHER

Principal Investigators

  • Naveed Siddiqui, MD · MOUNT SINAI HOSPITAL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Canada

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02264795 on ClinicalTrials.gov