NCT02264795

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 15, 2014

Completed
17 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

May 3, 2016

Status Verified

May 1, 2016

Enrollment Period

1 year

First QC Date

October 9, 2014

Last Update Submit

May 2, 2016

Conditions

Pain

Keywords

Cesarean sectionLidocaine

Outcome Measures

Primary Outcomes (1)

  • Pain Score (VAS) 24hr movement

    VAS score (VAS 0-100 mm) for maternal pain on movement at 24 hours postcesarean delivery

    24 hours

Secondary Outcomes (15)

  • Anxiety score before surgery (VAS)

    5 minutes

  • Pain score (VAS) 2hr rest

    2 hours

  • Pain score (VAS) 2hr movement

    2 hours

  • Pain Score (VAS) 24hr rest

    24 hours

  • Pain Score (VAS) 48hr rest

    48 hours

  • +10 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Intraperitoneal instillation of normal saline.

Drug: Placebo

Lidocaine

ACTIVE COMPARATOR

Intraperitoneal instillation lidocaine 2% (400mg) with epinephrine 5mcg/ml.

Drug: Lidocaine

Interventions

LidocaineDRUG

Lidocaine 2% with epinephrine 5mcg/ml

Also known as: Lidocaine HCl
Lidocaine
PlaceboDRUG

0.9% Sodium Chloride Solution

Also known as: Normal saline
Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ASA I or II patients
  • years of age
  • Term pregnancy
  • Singleton pregnancy
  • Spinal anesthetic
  • Pfannenstiel incision
  • Patients who have given pre-operative informed written consent

You may not qualify if:

  • Patients who refuse or are unable to give consent
  • ASA \>2
  • Multiple gestation
  • Chronic pain
  • BMI \>40
  • Contraindication to acetaminophen or non-steroidal anti-inflammatory drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

MeSH Terms

Conditions

Pain

Interventions

LidocaineSaline Solution

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Naveed Siddiqui, MD

    MOUNT SINAI HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2014

First Posted

October 15, 2014

Study Start

November 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

May 3, 2016

Record last verified: 2016-05

Locations

CA(1)