NCT01492179

Brief Summary

Local anesthetics (LA) are increasingly used for postoperative pain management. Speicifically, several studies have found benefit of LA injected intra-abdominally following abdominal hysterectomy. However, it remains unclear whether the pain relief seen is due to local anesthetic mechanisms within the abdominal cavity or through systemic absorption. The aim of this study is to assess whether lidocaine administered intravenously has similar analgesic efficacy as the same dose administered intra-abdominally in patients undergoing abdominal hysterectomy. All patients would have rescue analgesia using the patient controlled analgesia (PCA) pump with morphine in order to achieve adequate pain management during 24 h.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2011

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

Study Start

First participant enrolled

November 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 12, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

May 28, 2014

Status Verified

May 1, 2014

Enrollment Period

1.6 years

First QC Date

December 12, 2011

Last Update Submit

May 25, 2014

Conditions

Uterine MyomaPersistent Post-menpausal BleedingUterine Cancer

Keywords

Surgery: Abdominal hysterectomyAnesthetics: LocalPostoperative: PainDrugs: Morphine

Outcome Measures

Primary Outcomes (1)

  • Morphine consumption

    Total rescue morphine consumption during 0 - 24 h would be the primary endpoint

    0 - 24 h postoperatively

Secondary Outcomes (3)

  • Postoperative pain

    4 h postoperatively

  • Plasma concentration of lidocaine

    24 h

  • Length of Hospital stay

    1-5 days

Study Arms (3)

Intravenous Lidocaine

ACTIVE COMPARATOR

Intravenous lidocaine would be administered as an infusion for pain management both intra- and post-operatively.

Drug: Intravenous Lidocaine

Intra-abdominal Lidocaine

ACTIVE COMPARATOR

Lidocaine would be administered intermittently, once each hour intra-abdominally for postoperative pain management.

Drug: Intra-abdominal Lidocaine

Normal saline

PLACEBO COMPARATOR

Normal saline would be administered intra-abdominally and intravenously in the same patient. Rescue analgesia in the form of morphine (PCA) would be used for pain management.

Drug: Normal saline

Interventions

Normal salineDRUG

Normal saline would be administered intravenously and intra-abdominally.

Normal saline
Intravenous LidocaineDRUG

Standardized infusion of lidocaine during 24 h. 100 mg bolus and 50 mg/h during 24 h would be administered.

Also known as: Xylocaine 5 mg/ml
Intravenous Lidocaine
Intra-abdominal LidocaineDRUG

Lidocaine 5 mg/ml; 100 mg would be administered intraoperatively intra-abdominally and subsequently 50 mg/h as intermittent injection intra-abdominally during 24 h

Also known as: Xylocaine 5 mg/ml
Intra-abdominal Lidocaine

Eligibility Criteria

Age30 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA 1-2
  • yrs
  • Informed consent

You may not qualify if:

  • Allergy to LA
  • Chronic pain
  • Major liver/kidney insufficiency
  • AV Block 1-2 Participation in another clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Örebro University Hospital

Örebro, 701 85, Sweden

Location

MeSH Terms

Conditions

MyofibromaUterine NeoplasmsPain, Postoperative

Interventions

Saline SolutionLidocaine

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsConnective Tissue DiseasesSkin and Connective Tissue DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Kjell Axelsson, MD, PhD

    Örebro University Hospital, Örebro, Sweden

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 12, 2011

First Posted

December 14, 2011

Study Start

November 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

May 28, 2014

Record last verified: 2014-05

Locations

SE(1)