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Ilioinguinal Block in Laparoscopic Inguinal Hernia Repair

Primary Purpose

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

Status
Withdrawn
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Marcaine ½%
Needle prick
Sponsored by
Randers Regional Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Operative Pain as Estimated by the Sue of the VAS Score focused on measuring inguinal hernia, postoperative pain, localanesthesia, nerve blockage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥ 18 year
  2. Informed consent
  3. a diagnosis of an inguinal hernia
  4. ASA group ≤ 3
  5. BMI ≤ 35

Exclusion Criteria:

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

Sites / Locations

  • Horsens Regions Hospital
  • Randers regions Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Injection of Marcaine ½ %

Needle prick

Arm Description

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

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

Outcomes

Primary Outcome Measures

Post operative pain
VAS score of pain from: wound abdomen shoulder

Secondary Outcome Measures

Full Information

First Posted
October 21, 2013
Last Updated
December 16, 2014
Sponsor
Randers Regional Hospital
Collaborators
Regionshospitalet Horsens, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT01969006
Brief Title
Ilioinguinal Block in Laparoscopic Inguinal Hernia Repair
Official Title
Effect of Ilioinguinal Blockage on Postoperative Pain After Laparoscopic Inguinal Herna Repair
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Withdrawn
Why Stopped
Another study has been planned, so we did not initiate this one.
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Randers Regional Hospital
Collaborators
Regionshospitalet Horsens, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: pre-operatively 1 hour postoperatively at discharge from the hospital d day 1,2 and 3 post OP e. 1 year post OP
Detailed Description
as above

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain as Estimated by the Sue of the VAS Score
Keywords
inguinal hernia, postoperative pain, localanesthesia, nerve blockage

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Injection of Marcaine ½ %
Arm Type
Experimental
Arm Description
Injection of 40 ml of Marcaine ½ % 2 cm medial, 2 cm downwards from the Anterior Iliac Spine
Arm Title
Needle prick
Arm Type
Placebo Comparator
Arm Description
Needle prick 2 cm medial and 2 cm downwards from the Anterior Iliac spine
Intervention Type
Drug
Intervention Name(s)
Marcaine ½%
Intervention Type
Procedure
Intervention Name(s)
Needle prick
Primary Outcome Measure Information:
Title
Post operative pain
Description
VAS score of pain from: wound abdomen shoulder
Time Frame
1 year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 year Informed consent a diagnosis of an inguinal hernia ASA group ≤ 3 BMI ≤ 35 Exclusion Criteria: Communication problems No consent Open procedure (not laparoscopic) ASA-group 4 Use of Steroid or immunosuppressive tretament Regular morphine use.
Facility Information:
Facility Name
Horsens Regions Hospital
City
Horsens
ZIP/Postal Code
8700
Country
Denmark
Facility Name
Randers regions Hospital
City
Randers
ZIP/Postal Code
8900
Country
Denmark

12. IPD Sharing Statement

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Ilioinguinal Block in Laparoscopic Inguinal Hernia Repair

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