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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Inguinal Hernia, Pain, Postoperative

Intervention / Treatment
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* Drug: Oksykodonhydroklorid
* Drug: Ondansetron and Droperidol
* Drug: Ropivacaine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0 - 7 days postoperative. | 
| 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. | 0 - 7 days postoperative. | 
| Opioid consumption measured in orale morphine equivalents. | Opioid consumption measured at 24 hours, 48 hours and seven days. | 4 hours- 7 days postopertive. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anterior Quadratus Lumborum block, Transversus Abdominis block, Truncal block