Biliary Disease
Conditions
Keywords
Unilateral transversus abdominal plane block, Local infiltration anesthesia, Cholecystectomy, Postoperative analgesia
Brief summary
Laparoscopic cholecystectomy is a commonly performed operation in general surgery practice. Peripheral nerve block methods commonly used for analgesia after this operation are: transversus abdominis plane block (TAP) and trocar insertion sites local anesthetic infiltration anesthesia In this study, we aimed to compare these methods in terms of postoperative analgesia, nausea-vomiting and patient satisfaction
Detailed description
Patients will be randomly allocated by a computer generated random numbers list into three groups. After general anesthesia induction and intubation patients will receive analgesia according to group allocation. In group TAP (Group T) the transversus abdominis plane block will be commenced with ultrasound guidance while the patients is in the supine position with a subcostal approach using 20 mL 0.25% bupivacaine and 21 G block needle. In group infiltration anesthesia (Group I) the trocar insertion sites will be infiltrated with 20 mL 0.25% bupivacaine: 7 mL for the 10 mm trocar insertion sites and 3 mL for the 5 mm trocar insertion sites. The control group (Group C) will not receive any local anesthetic. All patients will receive rescue analgesia with intravenous patient controlled analgesia with tramadol (20 mg bolus dose and 20 minutes lockout time) Postoperative pain will be assessed during resting and coughing with a Numeric Pain Scale (NRS) and nausea and vomiting with a Postoperative Nausea Vomiting Score at the postoperative 1, 3, 6, 12. and 24 hours. The amount of tramadol consumed in the postoperative period will be recorded. Patient satisfaction will be assessed with the Likert scale at postoperative 24 hours.
Interventions
DRUGTransversus abdominis plane block
will receive 20ml bupivacaine for Transversus abdominis plane block and intravenous patient controlled analgesia
will receive 20ml bupivacaine for local infiltration anesthesia and intravenous patient controlled analgesia
will not receive any regional anesthetic intervention will receive intravenous patient controlled analgesia
Sponsors
Diskapi Yildirim Beyazit Education and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
patients and outcome assesors will be blinded for the analgesia method
Intervention model description
prospective randomised
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
• Clinical diagnosis of biliary disease
Exclusion criteria
* Uncooperative patients * Blood coagulation disorders * Laparatomy * Obesity: body mass index \>35 * Renal failure * Hepatic failure * Emergency surgery * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative analgesia | Postoperative day 1 | Pain will be assessed with a 11 point numeric rating scale (0-10 whereas 0:no pain; 1-3: mild pain; 4-6: moderate pain and 7-10: severe pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative nausea and vomiting (PONV) | Postoperative 1st hour, 3rd hour, 6th hour, 12th hour and 24th hour | PONV will be assessed with a 5 point PONV intensity scale (1-4 whereas 1:absence of PONV; 2: nausea present, vomiting absent; 3 nausea present, vomiting once; 4: nausea present vomiting twice or more |
| Patient satisfaction | Postoperative 24 th hour | Satisfaction will be assessed with a 5 point Likert scale (0-4 whereas 0:definitely disagree; 1:slightly agree; 3: agree; 4: strongly agree) |
Countries
Turkey (Türkiye)
Outcome results
None listed