Laparoscopic Cholecystectomy
Conditions
Keywords
Acute pain management, Ropivacaine, Trocar-site infiltration, TAP-block, Laparoscopic cholecystectomy
Brief 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.
Interventions
PROCEDURETrocar-site infiltration
20 mL of ropivacaine 0.375% (6 mL in 10 mm trocar site and 4 mL in 6 mm trocar site)
PROCEDURETAP block
bilateral ultrasound-guided TAP block with 20 mL of ropivacaine 0.375% in each side
PROCEDURETrocar site infiltration placebo
20 mL of normal saline
PROCEDURETAP block placebo
bilateral ultrasound-guided TAP block with 20 mL of normal saline in each side
Sponsors
Tunis University
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute postoperative pain | up to 24 hours | Visual analog scale (VAS) 0: no pain to 10: severe pain at rest and cough |
| Total opioid consumption | Day 1 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative nausea and vomiting | Day 1 | — |
| Postoperative complication | up to 1 week | Ileus, wound infection, wound abscess |
| Incidence of shoulder pain | Day 1 | — |
| Patient satisfaction and quality of recovery | Day 1 | QoR-40 questionnaire |
| Length of hospital stay | up to 1 week | — |
Countries
Tunisia
Contacts
Primary ContactDAGHMOURI Mohamed Aziz, M.D
Outcome results
None listed