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.
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
- Conditions the study is for
- Laparoscopic Cholecystectomy, Postoperative Analgesia
- 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.
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 group | Role | What they receive |
|---|---|---|
| levobupivacaine | Active comparator | Echo-guided bilateral subcostalTAP block will be performed using levobupivacaine [Chirocaine®] 0.375% Epi 1/200000. Receives: Procedure: Bilateral subcostal TAP block |
| Saline | Placebo comparator | Echo-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.
postoperative opioid consumption
opioid given as an IV titration in the PACU, and opioid po on the ward
Measured: 24 hours
Secondary outcomes (4)
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
postoperative nausea and vomiting
PONV measured on 0-10 visual analog scale
Measured: 24 hours
postoperative fatigue
measured on 0-10 visual analog scale
Measured: 24 hours
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.
- First posted5 Jan 2018
- Study start27 Dec 2017
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean François Brichant, University of Liege
- Investigators
- Jean L Joris, M.D., Principal investigator, Department of Anesthesiology, CHU Liege, Belgium
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-controlled, Randomized, Double-blind Trial of Transversus Abdominis Plane Block on Pain After Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT03391531
- Acronym / sponsor ID
- TAPLAPCHOL
- Keywords
- surgery: laparoscopic cholecystectomy, analgesia: postoperative, locoregional analgesia: transversus abdominis plane block, opioid: side effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 27 Dec 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 5 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- two groups : treatment group (TAP block with local anesthestic) compared to control group (TAP block with saline)
| Arm | Type | Receives |
|---|---|---|
| levobupivacaine | Active comparator | Procedure: Bilateral subcostal TAP blockEcho-guided bilateral subcostalTAP block will be performed using levobupivacaine [Chirocaine®] 0.375% Epi 1/200000. |
| Saline | Placebo comparator | Procedure: Bilateral subcostal TAP blockEcho-guided bilateral subcostal TAP block will be performed with saline Epi 1/200000 in the control group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients aged 18-75 yo scheduled for laparoscopic cholecystectomy
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral subcostal TAP blockEcho-guided infiltration of a local anesthetic solution in the plane located between the transversus abdominis muscle and the rectus abdominis muscle | Procedure or surgery | Saline, levobupivacaine |
Primary outcome
postoperative opioid consumption
Time frame: 24 hours
opioid given as an IV titration in the PACU, and opioid po on the ward
4 secondary outcomes
postoperative pain intensity
Time frame: 24 hours
postoperative nausea and vomiting
Time frame: 24 hours
postoperative fatigue
Time frame: 24 hours
intraoperative sevoflurane consumption
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean L Joris, M.D. principal investigator
Department of Anesthesiology, CHU Liege, Belgium
1 site in 1 country: see every site and its status.
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.