Trocar-site Infiltration Versus TAP-block

Laparoscopic Cholecystectomy Clinical Trial

Official title:

Trocar-site Infiltration With Ropivacaine Versus Tranversus Abdominis Plane Block Following Laparoscopic Cholecystectomy: a Double-blinded, Randomized-controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05094193
• Other study ID #: HTHEC-2021-29
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: October 2021
• Source: Tunis University
• Contact: DAGHMOURI Mohamed Aziz, M.D
• Phone: 0029442474
• Email: aziz.daghmouri[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

For symptomatic gall bladder disorders (cholelithiasis and cholecystitis), laparoscopic cholecystectomy (LC) has been considered as the gold standard treatment. However, these minimally invasive technique is associated with acute moderate pain during the 24 hours postoperative, which is routinely managed using opioids. The transversus abdominis plane (TAP) block has been used as part of a multimodal analgesia strategy. Besides, Wang et al found that TAP block is more effective than a conventional pain control, but not significatively different from another local incisional pain control that is port site infiltration.So, the aim of this study, is to compare the analgesic efficacy and safety of trocar-site infiltration with ropivacaine with ultrasound-guided TAP block following laparoscopic cholecystectomy when used as part of multimodal analgesia.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• BMI < 30 kg/m2

• Scheduled for laparoscopic cholecystectomy

• ASA grade I, II and III

Exclusion Criteria:

• Bile duct exploration, insertion of a T-drain or patients with acute cholecystitis

• Conversion to open cholecystectomy or if the surgery exceeded 200 minutes

• Severe systemic disease

• Patients on analgesics for any reason

• History of allergy to local anesthetics

• An ongoing pregnancy

• Patient refusal

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy

Intervention

Procedure:
• Trocar-site infiltration
20 mL of ropivacaine 0.375% (6 mL in 10 mm trocar site and 4 mL in 6 mm trocar site)
• TAP block
bilateral ultrasound-guided TAP block with 20 mL of ropivacaine 0.375% in each side
• Trocar site infiltration placebo
20 mL of normal saline
• TAP block placebo
bilateral ultrasound-guided TAP block with 20 mL of normal saline in each side

Locations

Country	Name	City	State
Tunisia	Habib Thameur Hospital	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
Tunis University

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute postoperative pain	Visual analog scale (VAS) 0: "no pain" to 10: "severe pain" at rest and cough	up to 24 hours
Primary	Total opioid consumption		Day 1
Secondary	Length of hospital stay		up to 1 week
Secondary	postoperative nausea and vomiting		Day 1
Secondary	Patient satisfaction and quality of recovery	QoR-40 questionnaire	Day 1
Secondary	Incidence of shoulder pain		Day 1
Secondary	Postoperative complication	Ileus, wound infection, wound abscess	up to 1 week