Transversus Abdominis Plane Block (TAP) for Laparoscopic Cholecystectomy Surgery

Pain, Postoperative Clinical Trial

Official title:

Comparison Of Ultrasound Guided Transversus Abdominis Plane Block (TAP) and Local Infiltration Analgesia During Laparoscopic Cholecystectomy Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02185716
• Other study ID #: 2013-414
• Status: Completed
• Phase: Phase 4
• Start date: January 2014
• Est. completion date: August 2016

Study information

• Verified date: July 2020
• Source: Duzce University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Postoperative pain is a significant cause of increased morbidity in the perioperative period, leading to patient discomfort and greater hospital length of stay. Laparoscopic cholecystectomy associated with significant postoperative pain, a substantial component of which is derived from abdominal wall incisions. Ultrasound-guided TAP block increasingly has been used for providing pain relief following abdominal surgery. We designed this study with the hypothesis that, administering TAP block with levobupivacaine in laparoscopic cholecystectomy provides superior analgesic effects than port-side infiltration.

Description:

In this randomized and double-blind study, 75 patients, American Society of Anesthesiology (ASA) I-II risk group, between the ages of 20-60, who will undergo elective laporoscopic cholecystectomy operation under general anesthesia will be accepted. The patients will be divided into three groups and they will be given postoperative pain treatment with patient-controlled analgesia device. In hours of postoperative 1, 2, 4, 8, 12, 16 and 24, Visual analog scale (VAS) I (superficial pain), VAS II (deep pain), postoperative total analgesic proportion, nausea and vomiting, evaluation postoperative sedation score will be recorded (as conscious:0, asleep:1, deep sleep:2 ) in hours of postoperative 1, 2, 4, 8, 12, 16 and 24.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: August 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• ASA I-II risk group,

• between the ages of 20-60,

• undergo elective laporoscopic cholecystectomy operation under general anesthesia

Exclusion Criteria:

• allergy to anesthetic medication,

• coronary artery patients,

• obese patients,

• emergencies,

• pregnants,

• abdomen operation history

• heart block

Related Conditions & MeSH terms

• Cholecystectomy, Laparoscopic
• Pain, Postoperative

Intervention

Drug:
• Levobupivacaine 0.25 %

• Levobupivacaine 0.5%

Locations

Country	Name	City	State
Turkey	Duzce University Medical Faculty	Duzce

Sponsors (1)

Lead Sponsor	Collaborator
Duzce University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Keir A, Rhodes L, Kayal A, Khan OA. Does a transversus abdominis plane (TAP) local anaesthetic block improve pain control in patients undergoing laparoscopic cholecystectomy? A best evidence topic. Int J Surg. 2013;11(9):792-4. doi: 10.1016/j.ijsu.2013.05 — View Citation

Wassef M, Lee DY, Levine JL, Ross RE, Guend H, Vandepitte C, Hadzic A, Teixeira J. Feasibility and analgesic efficacy of the transversus abdominis plane block after single-port laparoscopy in patients having bariatric surgery. J Pain Res. 2013 Nov 27;6:83 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	side effects	In hours of postoperative 1, 2, 4, 8, 12, 16 and 24 nausea, and vomiting will be recorded.Nausea (0=non-existent, 1=mild, 2 = severe) and vomiting (0=non-existent, 1=mild, 2 = severe) of the patients will be scored postoperatively on a 3-point scale.	postoperatively 24 h
Primary	postoperative pain scores	VAS I (superficial pain), VAS II (deep pain) recorded in hours of postoperative 1, 2, 4, 8, 12, 16 and 24 h,	24 hours
Secondary	postoperative total analgesic consumption		Postoperatively 24 h