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

Not Applicable

Completed

• Conditions: Biliary Disease
• Interventions: Drug: Intravenous patient controlled analgesia; Drug: Transversus abdominis plane block; Drug: local infiltration anesthesia

• Registration Number: NCT03543202
• Lead Sponsor: Diskapi Yildirim Beyazit Education and Research Hospital

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.

Study Timeline

• Study First Submitted: 2018-05-17
• Study First Submitted QC: 2018-05-31
• Study First Posted: 2018-06-01
• Study Start: 2018-06-10
• Primary Completion: 2019-05-10
• Study Completion: 2019-05-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous patient control analgesia	Intravenous patient controlled analgesia	will not receive any regional anethetic intervention will receive intravenous patient controlled analgesia
Transversus abdominis plane block	Transversus abdominis plane block	will receive 20ml bupivacaine for Transversus abdominis plane block and intravenous patient controlled analgesia
Transversus abdominis plane block	Intravenous patient controlled analgesia	will receive 20ml bupivacaine for Transversus abdominis plane block and intravenous patient controlled analgesia
Local infiltration anesthesia	local infiltration anesthesia	will receive 20ml bupivacaine for Local infiltration anesthesia and intravenous patient controlled analgesia
Local infiltration anesthesia	Intravenous patient controlled analgesia	will receive 20ml bupivacaine for Local infiltration anesthesia and intravenous patient controlled analgesia

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
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

Trial Locations

Locations (1)

Diskapi Yıldırım Beyazıt EAH; 🇹🇷 Ankara, Turkey