Efficacy of an Anterior Quadratus Lumborum Block vs. a TAP-block for Inguinal Hernia Repair

NCT03023462 | Completed DMC

• 1 other identifier: AB3384
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

One of the most common complications after hernia repair is postoperative and chronic pain. TAP (transverse abdominis plain) block is a recommended multimodal method of reducing postoperative pain in laparoscopic and open inguinal hernia repair. The objective of this study is to determine whether the use of a perioperative echo guided unilateral TAP block has a superior effect on postoperative pain after laparoscopic inguinal repair compared to an anterior Quadratus Lumborum Block with a long acting local anesthetic.

Conditions

Inguinal Hernia; Pain, Postoperative

Keywords

Anterior Quadratus Lumborum block; Transversus Abdominis block; Truncal block

Outcome Measures

Primary Outcomes (1)

• Opioid consumption measured as orale morphine equivalents.

  Differences in opioid consumption after four hours.

  0 - 4 hours

Secondary Outcomes (3)

• Postoperative nausea and vomiting

  0 - 7 days postoperative.

• Sedation scores

  0 - 7 days postoperative.

• Opioid consumption measured in orale morphine equivalents.

  4 hours- 7 days postopertive.

Study Arms (2)

Transmuscular Quadratus lumborum Block

ACTIVE COMPARATOR

A single shot unilateral transmuscular Quadratus lumborum Block with Ropivacaine 7,5 mg/ml, 20 ml

Drug: Oksykodonhydroklorid; Drug: Ondansetron and Droperidol; Drug: Ropivacaine

TAP Block

ACTIVE COMPARATOR

A single shot unilateral TAP block with Ropivacaine 7,5 mg/ml, 20 ml

Drug: Oksykodonhydroklorid; Drug: Ondansetron and Droperidol; Drug: Ropivacaine

Interventions

Oksykodonhydroklorid DRUG

Oksykodonhydroklorid, 5 - 10 mg intravenously or orally postoperatively to reduce pain. Repetition until effect.

Also known as: oxycodone

TAP Block; Transmuscular Quadratus lumborum Block

Ondansetron and Droperidol DRUG

When nausea and vomiting: Ondansetron 4mg and droperidol 0,625 mg intravenously

Also known as: Ondansetron and Dridol

TAP Block; Transmuscular Quadratus lumborum Block

Ropivacaine DRUG

Local anesthetic for the block

TAP Block; Transmuscular Quadratus lumborum Block

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• BMI (body mass index) 20-35
• ASA (American Association of Anesthesiologists Classification system for physical status) I-III.
• Scheduled for elective laparoscopic inguinal hernia operation

You may not qualify if:

• Allergy to latex, local anesthesia or opioids
• Chronic pain with daily opiate use
• Patients with severe renal and/or hepatic disease
• Local infection at the site of injection
• Systemic infection
• AV block 2-3
• Inability to understand written or spoken Norwegian
• Inability to cooperate
• Dementia
• Known abuse of alcohol or medication
• Coagulation disorder
• Pregnancy Previously operated with same side operation.

Sponsors & Collaborators

• Ostfold Hospital Trust: lead

Study Sites (1)

Ostfold Hospital Trust, Moss

Moss, Østfold fylke, 1500, Norway

Location

Related Publications (6)

• Berndsen FH, Petersson U, Arvidsson D, Leijonmarck CE, Rudberg C, Smedberg S, Montgomery A; SMIL Study Group. Discomfort five years after laparoscopic and Shouldice inguinal hernia repair: a randomised trial with 867 patients. A report from the SMIL study group. Hernia. 2007 Aug;11(4):307-13. doi: 10.1007/s10029-007-0214-7. Epub 2007 Apr 18.

  PMID: 17440795 BACKGROUND

• El-Dawlatly AA, Turkistani A, Kettner SC, Machata AM, Delvi MB, Thallaj A, Kapral S, Marhofer P. Ultrasound-guided transversus abdominis plane block: description of a new technique and comparison with conventional systemic analgesia during laparoscopic cholecystectomy. Br J Anaesth. 2009 Jun;102(6):763-7. doi: 10.1093/bja/aep067. Epub 2009 Apr 17.

  PMID: 19376789 BACKGROUND

• Meyer A, Bonnet L, Bourbon M, Blanc P. Totally extraperitoneal (TEP) endoscopic inguinal hernia repair with TAP (transversus abdominis plane) block as a day-case: a prospective cohort study. J Visc Surg. 2015 Jun;152(3):155-9. doi: 10.1016/j.jviscsurg.2014.12.005. Epub 2015 Jan 6.

  PMID: 25575582 BACKGROUND

• Nienhuijs SW, Boelens OB, Strobbe LJ. Pain after anterior mesh hernia repair. J Am Coll Surg. 2005 Jun;200(6):885-9. doi: 10.1016/j.jamcollsurg.2005.02.005.

  PMID: 15922201 BACKGROUND

• Petersen PL, Mathiesen O, Stjernholm P, Kristiansen VB, Torup H, Hansen EG, Mitchell AU, Moeller A, Rosenberg J, Dahl JB. The effect of transversus abdominis plane block or local anaesthetic infiltration in inguinal hernia repair: a randomised clinical trial. Eur J Anaesthesiol. 2013 Jul;30(7):415-21. doi: 10.1097/EJA.0b013e32835fc86f.

  PMID: 23549122 BACKGROUND

• Adhikary SD, El-Boghdadly K, Nasralah Z, Sarwani N, Nixon AM, Chin KJ. A radiologic and anatomic assessment of injectate spread following transmuscular quadratus lumborum block in cadavers. Anaesthesia. 2017 Jan;72(1):73-79. doi: 10.1111/anae.13647. Epub 2016 Oct 12.

  PMID: 27730633 BACKGROUND

MeSH Terms

Conditions

Hernia, Inguinal; Pain, Postoperative

Interventions

Oxycodone; Ondansetron; Droperidol; Ropivacaine

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, 3-Ring; Butyrophenones; Ketones; Organic Chemicals; Benzimidazoles; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Jan Sverre Vamnes, MD, Ph.D.

  Senior consultant

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Computer generated randomization with allocation in opaque envelopes. Randomization performed by other study personell than care provider.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * Group QLB: Anterior Quadratus Lumborum Block using ropivacaine 7,5 mg/ml, 20ml. Subcutaneous wound infiltration in all patients with ropivacaine 5 mg/ml,10 ml. * Group TAP: Transversus abdominis plane block using ropivacaine 7,5 mg/ml, 20 ml Subcutaneous wound infiltration in all patients with ropivacaine 5 mg/ml,10 ml.

Study Record Dates

• First Submitted: January 3, 2017
• First Posted: January 18, 2017
• Study Start: September 5, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: November 18, 2021

Record last verified: 2021-11

Locations

NO (1)