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Transversus Abdominis Plane Block (TAP) for Laparoscopic Cholecystectomy Surgery

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02185716
Enrollment
75
Registered
2014-07-10
Start date
2014-01-31
Completion date
2016-08-31
Last updated
2020-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholecystectomy, Laparoscopic, Pain, Postoperative

Keywords

Transversus abdominis plane block, levobupivacaine

Brief 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.

Detailed 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.

Interventions

DRUGLevobupivacaine 0.25 %

Sponsors

Duzce University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
postoperative pain scores24 hoursVAS I (superficial pain), VAS II (deep pain) recorded in hours of postoperative 1, 2, 4, 8, 12, 16 and 24 h,

Secondary

MeasureTime frame
postoperative total analgesic consumptionPostoperatively 24 h

Other

MeasureTime frameDescription
side effectspostoperatively 24 hIn 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026