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

November 10, 2021 updated by: Ostfold Hospital Trust

Efficacy of the Anterior Quadratus Lumborum Block Versus the Transversus Abdominis Plane Block for Elective Laparoscopic Inguinal Hernia Repair: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Ostfold
      • Moss, Ostfold, Norway, 1500
        • Ostfold Hospital Trust, Moss

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 96 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Transmuscular Quadratus lumborum Block
A single shot unilateral transmuscular Quadratus lumborum Block with Ropivacaine 7,5 mg/ml, 20 ml
Drug: Oksykodonhydroklorid
Oksykodonhydroklorid, 5 - 10 mg intravenously or orally postoperatively to reduce pain. Repetition until effect.
Other Names:
  • oxycodone
Drug: Ondansetron and Droperidol
When nausea and vomiting: Ondansetron 4mg and droperidol 0,625 mg intravenously
Other Names:
  • Ondansetron and Dridol
Drug: Ropivacaine
Local anesthetic for the block
Active Comparator: TAP Block
A single shot unilateral TAP block with Ropivacaine 7,5 mg/ml, 20 ml
Drug: Oksykodonhydroklorid
Oksykodonhydroklorid, 5 - 10 mg intravenously or orally postoperatively to reduce pain. Repetition until effect.
Other Names:
  • oxycodone
Drug: Ondansetron and Droperidol
When nausea and vomiting: Ondansetron 4mg and droperidol 0,625 mg intravenously
Other Names:
  • Ondansetron and Dridol
Drug: Ropivacaine
Local anesthetic for the block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption measured as orale morphine equivalents.
Time Frame: 0 - 4 hours
Differences in opioid consumption after four hours.
0 - 4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative nausea and vomiting
Time Frame: 0 - 7 days postoperative.
Nausea is measured by a NRS score 0-3 at the timepoints 1,2,3 hours, 24 hours, 48 hours and 7 days.
0 - 7 days postoperative.
Sedation scores
Time Frame: 0 - 7 days postoperative.
Sedation is measured by a NRS score 0-3 at the timepoints 1,2,3 hours, 24 hours, 48 hours and 7 days.
0 - 7 days postoperative.
Opioid consumption measured in orale morphine equivalents.
Time Frame: 4 hours- 7 days postopertive.
Opioid consumption measured at 24 hours, 48 hours and seven days.
4 hours- 7 days postopertive.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ostfold Hospital Trust

Investigators

  • Study Chair: Jan Sverre Vamnes, MD, Ph.D., Senior consultant

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2019

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

January 3, 2017

First Submitted That Met QC Criteria

January 13, 2017

First Posted (Estimate)

January 18, 2017

Study Record Updates

Last Update Posted (Actual)

November 18, 2021

Last Update Submitted That Met QC Criteria

November 10, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AB3384

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

No sharing plan so far

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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