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
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.
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 |
Country | Name | City | State |
---|---|---|---|
Tunisia | Habib Thameur Hospital | Tunis |
Lead Sponsor | Collaborator |
---|---|
Tunis University |
Tunisia,
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 |
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