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

Primary Purpose

Inguinal Hernia, Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Oksykodonhydroklorid
Ondansetron and Droperidol
Ropivacaine
Sponsored by
Ostfold Hospital Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia focused on measuring Anterior Quadratus Lumborum block, Transversus Abdominis block, Truncal block

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria;

  • 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

Exclusion criteria:

  • 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.

Sites / Locations

  • Ostfold Hospital Trust, Moss

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Transmuscular Quadratus lumborum Block

TAP Block

Arm Description

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

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

Outcomes

Primary Outcome Measures

Opioid consumption measured as orale morphine equivalents.
Differences in opioid consumption after four hours.

Secondary Outcome Measures

Postoperative nausea and vomiting
Nausea is measured by a NRS score 0-3 at the timepoints 1,2,3 hours, 24 hours, 48 hours and 7 days.
Sedation scores
Sedation is measured by a NRS score 0-3 at the timepoints 1,2,3 hours, 24 hours, 48 hours and 7 days.
Opioid consumption measured in orale morphine equivalents.
Opioid consumption measured at 24 hours, 48 hours and seven days.

Full Information

First Posted
January 3, 2017
Last Updated
November 10, 2021
Sponsor
Ostfold Hospital Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03023462
Brief Title
Efficacy of an Anterior Quadratus Lumborum Block vs. a TAP-block for Inguinal Hernia Repair
Official Title
Efficacy of the Anterior Quadratus Lumborum Block Versus the Transversus Abdominis Plane Block for Elective Laparoscopic Inguinal Hernia Repair: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
September 5, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ostfold Hospital Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
One of the most common complications after hernia repair is postoperative and chronic pain. Postoperative pain is an expected but undesirable effect after an operation, which can result in an prolonged hospital stay or longer time to return fully to normal daily activities. There are indications that an insufficient treatment of postoperative pain is a risk factor for persistent or chronic pain after open and laparoscopic inguinal hernia repair (Berndsen FH 2007) (Nienhuijs SW 2005). TAP (transverse abdominis plain) block is a recommended multimodal method of reducing postoperative pain in laparoscopic and open surgery (El-Dawlatly AA 2009; 102). TAP block (Meyer A 2015) and an anterior Quadratus Lumborum Block (Adhikary, S.D. 2017) are both recommended for 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 the anterior Quadratus Lumborum Block with a long acting local anesthetic. There will be no further analysis in this study regarding the evidence of open hernia inguinal repair and chronic pain. The primary endpoint: Opioid consumption measured in orale morphine equivalents four hours postoperative. The secondary endpoints: Opoioid consumption measured in orale morphine equivalents after 24 hours, 48 hours and seven days postoperative. Postoperative nausea and vomiting measured on a NRS scale 0-3 at timepoints 1,2,3 hours, 24 hours, 48 hours and 7 days. Sedation scores measured on a NRS scale 0-3 at timepoints 1,2,3 hours, 24 hours, 48 hours and 7 days. . There will be conducted a telephone interview by a blinded study nurse at 24 h, 48 h and 7 days, interviewing the patients as to their NRS score, nausea, sedation, level of activity and satisfaction with their overall treatment. Power and Sample Size Calculator A pilot consisting of 12 patients was performed. The patients recieved a TAP block before a elective laparoscopic inguinal hernia repair. The mean oral morphine equivalents after four hours postoperative was 8.75 mg and the standard deviation 5.93 mg. With a significant clinical difference of 50%,an α = 0,05 and an effect size of 80% (β = 0,2) the total sample size is 60 patients with 30 patients in each group. Premedication: Paracetamol by weight (2 grams (g)>70 kilos (kg) <70 years, 1,5 g <70 kg >70 years, 1 g <50 kg) , Diclofenac by weight (100 milligrams (mg) >70 kg <70 years, 50 mg <70 kg >70 years). General anaesthesia: TCI (Target Control Infusion = Anesthesia protocol): Propofol and Remifentanil Surgical procedure: Laparoscopic inguinal hernia repair. 5 mg/ml 10 ml Ropivacaine in the ports peroperatively. Postoperatively: Oral paracetamol 1000 mg every 6 h In case of insufficient analgesia (NRS≥4) oxycodon 2-5 mg will be administered by a postoperative nurse. When nausea and vomiting occurs postoperatively, ondansetron 4 mg IV administers as the drug of first choice followed by droperidol 0,625 mg IV if the nausea/vomiting persists.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia, Pain, Postoperative
Keywords
Anterior Quadratus Lumborum block, Transversus Abdominis block, Truncal block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Computer generated randomization with allocation in opaque envelopes. Randomization performed by other study personell than care provider.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transmuscular Quadratus lumborum Block
Arm Type
Active Comparator
Arm Description
A single shot unilateral transmuscular Quadratus lumborum Block with Ropivacaine 7,5 mg/ml, 20 ml
Arm Title
TAP Block
Arm Type
Active Comparator
Arm Description
A single shot unilateral TAP block with Ropivacaine 7,5 mg/ml, 20 ml
Intervention Type
Drug
Intervention Name(s)
Oksykodonhydroklorid
Other Intervention Name(s)
oxycodone
Intervention Description
Oksykodonhydroklorid, 5 - 10 mg intravenously or orally postoperatively to reduce pain. Repetition until effect.
Intervention Type
Drug
Intervention Name(s)
Ondansetron and Droperidol
Other Intervention Name(s)
Ondansetron and Dridol
Intervention Description
When nausea and vomiting: Ondansetron 4mg and droperidol 0,625 mg intravenously
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
Local anesthetic for the block
Primary Outcome Measure Information:
Title
Opioid consumption measured as orale morphine equivalents.
Description
Differences in opioid consumption after four hours.
Time Frame
0 - 4 hours
Secondary Outcome Measure Information:
Title
Postoperative nausea and vomiting
Description
Nausea is measured by a NRS score 0-3 at the timepoints 1,2,3 hours, 24 hours, 48 hours and 7 days.
Time Frame
0 - 7 days postoperative.
Title
Sedation scores
Description
Sedation is measured by a NRS score 0-3 at the timepoints 1,2,3 hours, 24 hours, 48 hours and 7 days.
Time Frame
0 - 7 days postoperative.
Title
Opioid consumption measured in orale morphine equivalents.
Description
Opioid consumption measured at 24 hours, 48 hours and seven days.
Time Frame
4 hours- 7 days postopertive.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria; 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 Exclusion criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Sverre Vamnes, MD, Ph.D.
Organizational Affiliation
Senior consultant
Official's Role
Study Chair
Facility Information:
Facility Name
Ostfold Hospital Trust, Moss
City
Moss
State/Province
Ostfold
ZIP/Postal Code
1500
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
No sharing plan so far
Citations:
PubMed Identifier
17440795
Citation
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.
Results Reference
background
PubMed Identifier
19376789
Citation
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. Erratum In: Br J Anaesth. 2009 Oct;103(4):622.
Results Reference
background
PubMed Identifier
25575582
Citation
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.
Results Reference
background
PubMed Identifier
15922201
Citation
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.
Results Reference
background
PubMed Identifier
23549122
Citation
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.
Results Reference
background
PubMed Identifier
27730633
Citation
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.
Results Reference
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Efficacy of an Anterior Quadratus Lumborum Block vs. a TAP-block for Inguinal Hernia Repair

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