Analgesic Effect of TAP Block After Laparoscopic Cholecystectomy

Laparoscopic Cholecystectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03391531
• Other study ID #: TAPLAPCHOL
• Status: Completed
• Phase: N/A
• Start date: December 27, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: July 2018
• Source: University Hospital of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy
• Postoperative Analgesia

Intervention

Procedure:
• Bilateral subcostal TAP block
Echo-guided infiltration of a local anesthetic solution in the plane located between the transversus abdominis muscle and the rectus abdominis muscle

Locations

Country	Name	City	State
Belgium	CHU Liege,	Liège

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative opioid consumption	opioid given as an IV titration in the PACU, and opioid po on the ward	24 hours
Secondary	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	24 hours
Secondary	postoperative nausea and vomiting	PONV measured on 0-10 visual analog scale	24 hours
Secondary	postoperative fatigue	measured on 0-10 visual analog scale	24 hours
Secondary	intraoperative sevoflurane consumption	end-tidal sevoflurane concentration will be recorded	2 hours