Efficacy of an Anterior Quadratus Lumborum Block vs. a TAP-block for Inguinal Hernia Repair
NCT ID: NCT03023462
Last Updated: 2021-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2019-09-05
2020-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
* 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.
TREATMENT
TRIPLE
Study Groups
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Transmuscular Quadratus lumborum Block
A single shot unilateral transmuscular Quadratus lumborum Block with Ropivacaine 7,5 mg/ml, 20 ml
Oksykodonhydroklorid
Oksykodonhydroklorid, 5 - 10 mg intravenously or orally postoperatively to reduce pain. Repetition until effect.
Ondansetron and Droperidol
When nausea and vomiting: Ondansetron 4mg and droperidol 0,625 mg intravenously
Ropivacaine
Local anesthetic for the block
TAP Block
A single shot unilateral TAP block with Ropivacaine 7,5 mg/ml, 20 ml
Oksykodonhydroklorid
Oksykodonhydroklorid, 5 - 10 mg intravenously or orally postoperatively to reduce pain. Repetition until effect.
Ondansetron and Droperidol
When nausea and vomiting: Ondansetron 4mg and droperidol 0,625 mg intravenously
Ropivacaine
Local anesthetic for the block
Interventions
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Oksykodonhydroklorid
Oksykodonhydroklorid, 5 - 10 mg intravenously or orally postoperatively to reduce pain. Repetition until effect.
Ondansetron and Droperidol
When nausea and vomiting: Ondansetron 4mg and droperidol 0,625 mg intravenously
Ropivacaine
Local anesthetic for the block
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
100 Years
ALL
No
Sponsors
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Ostfold Hospital Trust
OTHER
Responsible Party
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Principal Investigators
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Jan Sverre Vamnes, MD, Ph.D.
Role: STUDY_CHAIR
Senior consultant
Locations
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Ostfold Hospital Trust, Moss
Moss, Østfold fylke, Norway
Countries
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References
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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.
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.
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.
Other Identifiers
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AB3384
Identifier Type: -
Identifier Source: org_study_id