NCT01969006

Brief Summary

This study is undertaken to clarify whether intraoperative blockage with 40 ml of ½ % Marcaine© of the nerves in the ilio-inguinal canal may decrease postoperative pain after laparoscopic inguinal hernia repair. Patients will be randomised to injection of Marcaine© og a needle prick per-operatively. Pain will be estimated using the VAS score in: 1\. the wound 2 the abdomen 3 the shoulder Scoring will be performed:

  1. 1.pre-operatively
  2. 2.1 hour postoperatively
  3. 3.at discharge from the hospital d day 1,2 and 3 post OP

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

2 active sites

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 24, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Last Updated

December 17, 2014

Status Verified

October 1, 2013

Enrollment Period

1 year

First QC Date

October 21, 2013

Last Update Submit

December 16, 2014

Conditions

Post Operative Pain as Estimated by the Sue of the VAS Score

Keywords

inguinal hernia, postoperative pain, localanesthesia, nerve blockage

Outcome Measures

Primary Outcomes (1)

  • Post operative pain

    VAS score of pain from: 1. wound 2. abdomen 3. shoulder

    1 year

Study Arms (2)

Injection of Marcaine ½ %

EXPERIMENTAL

Injection of 40 ml of Marcaine ½ % 2 cm medial, 2 cm downwards from the Anterior Iliac Spine

Drug: Marcaine ½%

Needle prick

PLACEBO COMPARATOR

Needle prick 2 cm medial and 2 cm downwards from the Anterior Iliac spine

Procedure: Needle prick

Interventions

Marcaine ½%DRUG
Injection of Marcaine ½ %
Needle prickPROCEDURE
Needle prick

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 year
  • Informed consent
  • a diagnosis of an inguinal hernia
  • ASA group ≤ 3
  • BMI ≤ 35

You may not qualify if:

  • Communication problems
  • No consent
  • Open procedure (not laparoscopic)
  • ASA-group 4
  • Use of Steroid or immunosuppressive tretament
  • Regular morphine use.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Horsens Regions Hospital

Horsens, 8700, Denmark

Location

Randers regions Hospital

Randers, 8900, Denmark

Location

MeSH Terms

Conditions

Hernia, InguinalPain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Surgeon phd, ass proffessor

Study Record Dates

First Submitted

October 21, 2013

First Posted

October 24, 2013

Study Start

January 1, 2014

Primary Completion

January 1, 2015

Last Updated

December 17, 2014

Record last verified: 2013-10

Locations

DK(2)