- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03023462
Efficacy of an Anterior Quadratus Lumborum Block vs. a TAP-block for Inguinal Hernia Repair
Efficacy of the Anterior Quadratus Lumborum Block Versus the Transversus Abdominis Plane Block for Elective Laparoscopic Inguinal Hernia Repair: A Randomized Controlled Trial
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ostfold
-
Moss, Ostfold, Norway, 1500
- Ostfold Hospital Trust, Moss
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
Oksykodonhydroklorid, 5 - 10 mg intravenously or orally postoperatively to reduce pain.
Repetition until effect.
Other Names:
When nausea and vomiting: Ondansetron 4mg and droperidol 0,625 mg intravenously
Other Names:
Local anesthetic for the block
|
Active Comparator: TAP Block
A single shot unilateral TAP block with Ropivacaine 7,5 mg/ml, 20 ml
|
Oksykodonhydroklorid, 5 - 10 mg intravenously or orally postoperatively to reduce pain.
Repetition until effect.
Other Names:
When nausea and vomiting: Ondansetron 4mg and droperidol 0,625 mg intravenously
Other Names:
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
Sponsor
Investigators
- Study Chair: Jan Sverre Vamnes, MD, Ph.D., Senior Consultant
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pathological Conditions, Anatomical
- Hernia, Abdominal
- Pain, Postoperative
- Hernia
- Hernia, Inguinal
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Antiemetics
- Gastrointestinal Agents
- Dermatologic Agents
- Analgesics, Opioid
- Narcotics
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Dopamine Agents
- Serotonin Antagonists
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- Adjuvants, Anesthesia
- Anti-Anxiety Agents
- Anesthetics, Local
- Antipruritics
- Ropivacaine
- Oxycodone
- Ondansetron
- Droperidol
Other Study ID Numbers
- AB3384
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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