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

NCT03543202 | Completed

• 1 other identifier: EmineTAP
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

Biliary Disease

Keywords

Unilateral transversus abdominal plane block; Local infiltration anesthesia; Cholecystectomy; Postoperative analgesia

Outcome Measures

Primary Outcomes (1)

• Postoperative analgesia

  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)

  Postoperative day 1

Secondary Outcomes (2)

• Postoperative nausea and vomiting (PONV)

  Postoperative 1st hour, 3rd hour, 6th hour, 12th hour and 24th hour

• Patient satisfaction

  Postoperative 24 th hour

Study Arms (3)

Transversus abdominis plane block

EXPERIMENTAL

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

Drug: Transversus abdominis plane block; Drug: Intravenous patient controlled analgesia

Local infiltration anesthesia

ACTIVE COMPARATOR

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

Drug: local infiltration anesthesia; Drug: Intravenous patient controlled analgesia

Intravenous patient control analgesia

SHAM COMPARATOR

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

Drug: Intravenous patient controlled analgesia

Interventions

Transversus abdominis plane block DRUG

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

Transversus abdominis plane block

local infiltration anesthesia DRUG

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

Local infiltration anesthesia

Intravenous patient controlled analgesia DRUG

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

Intravenous patient control analgesia; Local infiltration anesthesia; Transversus abdominis plane block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of biliary disease

You may not qualify if:

• Uncooperative patients
• Blood coagulation disorders
• Laparatomy
• Obesity: body mass index \>35
• Renal failure
• Hepatic failure
• Emergency surgery
• Pregnancy

Sponsors & Collaborators

• Diskapi Yildirim Beyazit Education and Research Hospital: lead

Study Sites (1)

Diskapi Yıldırım Beyazıt EAH

Ankara, Turkey (Türkiye)

Location

Related Publications (4)

• Chin KJ, McDonnell JG, Carvalho B, Sharkey A, Pawa A, Gadsden J. Essentials of Our Current Understanding: Abdominal Wall Blocks. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):133-183. doi: 10.1097/AAP.0000000000000545.

  PMID: 28085788 BACKGROUND

• Bava EP, Ramachandran R, Rewari V, Chandralekha, Bansal VK, Trikha A. Analgesic efficacy of ultrasound guided transversus abdominis plane block versus local anesthetic infiltration in adult patients undergoing single incision laparoscopic cholecystectomy: A randomized controlled trial. Anesth Essays Res. 2016 Sep-Dec;10(3):561-567. doi: 10.4103/0259-1162.186620.

  PMID: 27746552 RESULT

• Ortiz J, Suliburk JW, Wu K, Bailard NS, Mason C, Minard CG, Palvadi RR. Bilateral transversus abdominis plane block does not decrease postoperative pain after laparoscopic cholecystectomy when compared with local anesthetic infiltration of trocar insertion sites. Reg Anesth Pain Med. 2012 Mar-Apr;37(2):188-92. doi: 10.1097/AAP.0b013e318244851b.

  PMID: 22330261 RESULT

• El-Dawlatly AA, Turkistani A, Kettner SC, Machata AM, Delvi MB, Thallaj A, Kapral S, Marhofer P. Ultrasound-guided transversus abdominis plane block: description of a new technique and comparison with conventional systemic analgesia during laparoscopic cholecystectomy. Br J Anaesth. 2009 Jun;102(6):763-7. doi: 10.1093/bja/aep067. Epub 2009 Apr 17.

  PMID: 19376789 RESULT

MeSH Terms

Conditions

Gallbladder Diseases

Interventions

Anesthesia, Local; Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Analgesia

Study Officials

• Emine Arik, Dr

  Ministry f Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: patients and outcome assesors will be blinded for the analgesia method
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in Anesthesia

Model Details: prospective randomised

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: June 1, 2018
• Study Start: June 10, 2018
• Primary Completion: May 10, 2019
• Study Completion: May 30, 2019
• Last Updated: February 11, 2025

Record last verified: 2025-02

Locations

TU (1)