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Ilioinguinal Block in Laparoscopic Inguinal Hernia Repair

R

Randers Regional Hospital

Status and phase

Withdrawn
Phase 2

Conditions

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

Treatments

Procedure: Needle prick
Drug: Marcaine ½%

Study type

Interventional

Funder types

Other

Identifiers

NCT01969006
ILIOINGUINAL01

Details and patient eligibility

About

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

Full description

as above

Sex

Male

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

0 participants in 2 patient groups, including a placebo group

Injection of Marcaine ½ %
Experimental group
Description:
Injection of 40 ml of Marcaine ½ % 2 cm medial, 2 cm downwards from the Anterior Iliac Spine
Treatment:
Drug: Marcaine ½%
Needle prick
Placebo Comparator group
Description:
Needle prick 2 cm medial and 2 cm downwards from the Anterior Iliac spine
Treatment:
Procedure: Needle prick

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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