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Laparoscopic CholecystectomyNCT03391531

Analgesic Effect of TAP Block After Laparoscopic Cholecystectomy

A study testing Bilateral subcostal TAP block in people with Laparoscopic Cholecystectomy and Postoperative Analgesia, run by University of Liege at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

TAP block is a locoregional analgesic technique that consists of infiltrating a local anesthetic solution between the muscle layers of the abdominal wall. This block produces prolonged parietal analgesia. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Bilateral subcostal TAP block
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteBelgium
Study dates
27 Dec 2017to 30 Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • all patients aged 18-75 yo scheduled for laparoscopic cholecystectomy

Who cannot join

  • Coagulation disorders
  • Refusal of participation expressed by the patient
  • Fibromyalgia
  • Preoperative morphine treatment
  • Contraindications to local anesthetics: epilepsy, severe cardiac conduction block (2nd and 3rd degree AVB ), allergy
  • Contraindications to NSAIDs: renal failure, allergy, ischemic heart disease, stroke

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • CHU Liege,

    Liège, 4000

Other trials in Belgium

About this study

Official title: Placebo-controlled, Randomized, Double-blind Trial of Transversus Abdominis Plane Block on Pain After Laparoscopic Cholecystectomy

TAP block is a locoregional analgesic technique that consists of infiltrating a local anesthetic solution between the muscle layers of the abdominal wall. This block produces prolonged parietal analgesia.

The aim of the study is to evaluate whether infiltration of the abdominal wall using TAP block reduces postoperative pain and postoperative analgesic consumption, and improves patient comfort after laparoscopic cholecystectomy. This effect will be clinically relevant only if parietal pain predominates postoperatively.

Read the detailed description

Between 10 and 20% of the Western population suffer from gallstones. When a surgical operation (cholecystectomy) is necessary, the removal of the gallbladder is done by laparoscopy in 95% of cases. The risk of having to undergo this operation increases with age and on average women are twice as likely as men to have to undergo surgery. In Belgium, only 4% of these laparoscopic cholecystectomies are performed as one day hospitalization. Although this operation is considered a minor surgery, patients sometimes report intense postoperative pain that may encourage them to spend a night in the hospital. Better management of postoperative pain could increase the number of outpatient procedures. A large individual variability in pain intensity is observed after this surgical procedure. Three types of pain can be associated with this surgery: parietal pain secondary to the incisions of the wall necessary for the introduction of the surgical instruments; deep visceral pain, difficult to localize and secondary to surgical trauma in the area of dissection of the gall bladder; and scapular pain, a projected pain secondary to the irritation of the diaphragm by CO2-pneumoperitoneum. The temporal characteristics and intensity of these three types of pain are different. Some report a predominance of parietal pain, while for others visceral pain is most intense.

The Transversus Abdominis Plane (TAP) block is a loco-regional analgesia technique that consists of infiltrating a local anesthetic solution between the plane of the transversus abdominis muscle and the internal oblicus muscle, laterally at the level of the triangle of Petit. The sensory nerves of the abdominal wall pass through this plane. This technique produces long-lasting analgesia, between 24-36 hours. Only the nerves responsible for the innervation of the abdominal wall are blocked by this infiltration. The metameric extension of parietal analgesia varies from one study to another, especially depending on the site of infiltration. After posterior TAP block, parietal analgesia concerns the infra-umbilical abdominal wall, but can reach in some cases the dermatome T-8. When the surgery involves the supra-umbilical abdominal wall, the TAP block is performed at the subcostal level to block the nerve branches T-6 to T-10. Infiltration is then performed between the transverse muscle and the rectus abdominis at the lateral end of this muscle.

Several studies have evaluated the efficacy of TAP block for analgesia after laparoscopic cholecystectomy. Controversial results have been reported. These controversies can be explained in part by the type of TAP block used: lateral versus subcostal approach which appears more appropriate for laparoscopic cholecystectomy (supra-umbilical parietal incisions). In addition, effective multimodal analgesia, a recommended good medical practice, is not always used in these studies. This strategy, by effectively reducing postoperative pain, may make the clinical utility of TAP block irrelevant. Finally, in case of predominance of parietal pain on visceral pain, the clinical relevance of the TAP block should be objectified. In the opposite case (predominance of visceral pain), TAP block would be much less effective.

2.2 Purpose of the study. The purpose of this study is to evaluate the analgesic efficacy of TAP subcostal block after laparoscopic cholecystectomy. The effectiveness of the TAP block will confirm the importance of the parietal pain component after this type of surgery. Decreases in postoperative pain and postoperative opioid consumption, possibly associated with a decrease in morphine side effects (nausea, vomiting, sedation, fatigue), may be conducive to the development of outpatient laparoscopic cholecystectomy.

2.3 General description. This randomized double-blind placebo-controlled study will include two groups of 20 patients: the TAP block will be performed in a group using a local anesthetic solution (levobupivacaine [Chirocaine®] 0.375% Adr 1/200000) in the " treatment " group and with saline Adr 1/200000 in the control group.

Being tested
Bilateral subcostal TAP block
Keywords
surgery: laparoscopic cholecystectomy, analgesia: postoperative, locoregional analgesia: transversus abdominis plane block, opioid: side effects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bilateral subcostal TAP blockProcedure or surgery

    Echo-guided infiltration of a local anesthetic solution in the plane located between the transversus abdominis muscle and the rectus abdominis muscle

Study groups in NCT03391531
Study groupRoleWhat they receive
levobupivacaineActive comparatorEcho-guided bilateral subcostalTAP block will be performed using levobupivacaine [Chirocaine®] 0.375% Epi 1/200000.
Receives: Procedure: Bilateral subcostal TAP block
SalinePlacebo comparatorEcho-guided bilateral subcostal TAP block will be performed with saline Epi 1/200000 in the control group.
Receives: Procedure: Bilateral subcostal TAP block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. postoperative opioid consumption

    opioid given as an IV titration in the PACU, and opioid po on the ward

    Measured: 24 hours

Secondary outcomes (4)
  1. postoperative pain intensity

    postoperative pain will be separated out in parietal, visceral, and shouldertip pain; pain will be measured on 0-10 visual analog scale

    Measured: 24 hours

  2. postoperative nausea and vomiting

    PONV measured on 0-10 visual analog scale

    Measured: 24 hours

  3. postoperative fatigue

    measured on 0-10 visual analog scale

    Measured: 24 hours

  4. intraoperative sevoflurane consumption

    end-tidal sevoflurane concentration will be recorded

    Measured: 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2018
  2. Study start27 Dec 2017
  3. Primary completion30 Jun 2018
  4. Study completion30 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
two groups : treatment group (TAP block with local anesthestic) compared to control group (TAP block with saline)
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03391531
Sponsor's protocol ID
TAPLAPCHOL
Status last verified
Jul 2018
First submitted
29 Dec 2017
Last updated
17 Jul 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Bilateral subcostal TAP block in people with Laparoscopic Cholecystectomy and Postoperative Analgesia, run by University of Liege at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

postoperative opioid consumption (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.

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