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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03023462
Enrollment
60
Registered
2017-01-18
Start date
2019-09-05
Completion date
2020-06-30
Last updated
2021-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia, Pain, Postoperative

Keywords

Anterior Quadratus Lumborum block, Transversus Abdominis block, Truncal block

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.

Interventions

DRUGOksykodonhydroklorid

Oksykodonhydroklorid, 5 - 10 mg intravenously or orally postoperatively to reduce pain. Repetition until effect.

DRUGOndansetron and Droperidol

When nausea and vomiting: Ondansetron 4mg and droperidol 0,625 mg intravenously

DRUGRopivacaine

Local anesthetic for the block

Sponsors

Ostfold Hospital Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Computer generated randomization with allocation in opaque envelopes. Randomization performed by other study personell than care provider.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Opioid consumption measured as orale morphine equivalents.0 - 4 hoursDifferences in opioid consumption after four hours.

Secondary

MeasureTime frameDescription
Postoperative nausea and vomiting0 - 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.
Sedation scores0 - 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.
Opioid consumption measured in orale morphine equivalents.4 hours- 7 days postopertive.Opioid consumption measured at 24 hours, 48 hours and seven days.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026