Unilateral TAP Block vs Trocar Insertion Sites Infiltration Anesthesia in Laparoscopic Cholecystectomy

Diskapi Yildirim Beyazit Training and Research Hospital

Status: Completed

Conditions: Biliary Disease

Treatments: Drug: Intravenous patient controlled analgesia; Drug: Transversus abdominis plane block; Drug: local infiltration anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT03543202

EmineTAP

Details and patient eligibility

About

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

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 3 patient groups

Transversus abdominis plane block

Experimental group

Description:

will receive 20ml bupivacaine for Transversus abdominis plane block and intravenous patient controlled analgesia

Treatment:

Drug: Transversus abdominis plane block

Drug: Intravenous patient controlled analgesia

Local infiltration anesthesia

Active Comparator group

Description:

will receive 20ml bupivacaine for Local infiltration anesthesia and intravenous patient controlled analgesia

Treatment:

Drug: local infiltration anesthesia

Drug: Intravenous patient controlled analgesia

Intravenous patient control analgesia

Sham Comparator group

Description:

will not receive any regional anethetic intervention will receive intravenous patient controlled analgesia

Treatment:

Drug: Intravenous patient controlled analgesia