Ilioinguinal Block in Laparoscopic Inguinal Hernia Repair

Effect of Ilioinguinal Blockage on Postoperative Pain After Laparoscopic Inguinal Herna Repair

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

e. 1 year post OP

Study Overview

• Status: Withdrawn
• Conditions: Post Operative Pain as Estimated by the Sue of the VAS Score
• Intervention / Treatment: Drug: Marcaine ½%; Procedure: Needle prick

Detailed Description

as above

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Horsens, Denmark, 8700
    • Horsens Regions Hospital
  • Randers, Denmark, 8900
    • Randers regions Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Injection of Marcaine ½ %; Injection of 40 ml of Marcaine ½ % 2 cm medial, 2 cm downwards from the Anterior Iliac Spine	Drug: Marcaine ½%
Placebo Comparator: Needle prick; Needle prick 2 cm medial and 2 cm downwards from the Anterior Iliac spine	Procedure: Needle prick

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative pain	VAS score of pain from: wound; abdomen; shoulder	1 year

Collaborators and Investigators

• Sponsor: Randers Regional Hospital
• Collaborators: Regionshospitalet Horsens; Denmark

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): January 1, 2015

Study Registration Dates

• First Submitted: October 21, 2013
• First Submitted That Met QC Criteria: October 21, 2013
• First Posted (Estimate): October 24, 2013

Study Record Updates

• Last Update Posted (Estimate): December 17, 2014
• Last Update Submitted That Met QC Criteria: December 16, 2014
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: inguinal hernia, postoperative pain, localanesthesia, nerve blockage
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: ILIOINGUINAL01