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OpenTrials
Completed

NCT Number: NCT03023462

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ostfold Hospital Trust, Moss

Moss, Østfold fylke, 1500, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oksykodonhydroklorid

Drug

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

Other names: oxycodone

Ondansetron and Droperidol

Drug

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

Other names: Ondansetron and Dridol

Ropivacaine

Drug

Local anesthetic for the block

Primary outcomes

  1. Opioid consumption measured as orale morphine equivalents.

    Time frame: 0 - 4 hours

    Differences in opioid consumption after four hours.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Ostfold Hospital Trust

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 18, 2017
Registry last updated
Nov 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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