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

Biliary Disease Clinical Trial

Official title:

Comparison of Postoperative Analgesia and Patient Satisfaction of Unilateral Transversus Abdominis Plane (TAP) Block and Trocar Site Infiltration Anesthesia in Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03543202
• Other study ID #: EmineTAP
• Status: Recruiting
• Phase: N/A
• Start date: June 10, 2018
• Est. completion date: October 30, 2018

Study information

• Verified date: July 2018
• Source: Diskapi Yildirim Beyazit Education and Research Hospital
• Contact: Emine Arik, Dr
• Phone: +905333471530
• Email: emineincearik[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: October 30, 2018
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Biliary Disease
• Gallbladder Diseases

Intervention

Drug:
• Transversus abdominis plane block
will receive 20ml bupivacaine for Transversus abdominis plane block and intravenous patient controlled analgesia
• local infiltration anesthesia
will receive 20ml bupivacaine for local infiltration anesthesia and intravenous patient controlled analgesia
• Intravenous patient controlled analgesia
will not receive any regional anesthetic intervention will receive intravenous patient controlled analgesia

Locations

Country	Name	City	State
Turkey	Diskapi Yildirim Beyazit EAH	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Yildirim Beyazit Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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: — View Citation

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. Review. — View Citation

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 ch — View Citation

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 insertio — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Postoperative nausea and vomiting (PONV)	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	Postoperative 1st hour, 3rd hour, 6th hour, 12th hour and 24th hour
Secondary	Patient satisfaction	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 24 th hour