NCT02185716

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 10, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

July 22, 2020

Status Verified

July 1, 2020

Enrollment Period

1.5 years

First QC Date

July 7, 2014

Last Update Submit

July 20, 2020

Conditions

Cholecystectomy, LaparoscopicPain, Postoperative

Keywords

Transversus abdominis plane blocklevobupivacaine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • postoperative total analgesic consumption

    Postoperatively 24 h

Other Outcomes (1)

  • side effects

    postoperatively 24 h

Study Arms (3)

local infiltration

ACTIVE COMPARATOR

Group L (n=25) will be given total 30 ml 0.25 % levobupivacaine infiltration around trocar-site with injector in sterilized conditions without administering TAP block at the end of the operation

Drug: Levobupivacaine 0.5%

Control

NO INTERVENTION

Only routine general anesthesia will be applied

TAP

EXPERIMENTAL

Group T (n=25) will be given bilateral total 30 ml 0.25 % levobupivacaine administering TAP block under the guidance of ultrasound at the preoperative period.

Drug: Levobupivacaine 0.25 %

Interventions

Levobupivacaine 0.25 %DRUG
Also known as: chirocaine
TAP
Levobupivacaine 0.5%DRUG
Also known as: chirocaine
local infiltration

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA I-II risk group,
  • between the ages of 20-60,
  • undergo elective laporoscopic cholecystectomy operation under general anesthesia

You may not qualify if:

  • allergy to anesthetic medication,
  • coronary artery patients,
  • obese patients,
  • emergencies,
  • pregnants,
  • abdomen operation history
  • heart block

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duzce University Medical Faculty

Düzce, 81160, Turkey (Türkiye)

Location

Related Publications (2)

  • 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;6:837-41. doi: 10.2147/JPR.S50561. eCollection 2013.

    PMID: 24348067RESULT

  • 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.2013.05.039. Epub 2013 Jun 11.

    PMID: 23770342RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Levobupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

BupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Gülbin Sezen, MD,PhD

    Duzce University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant of professor

Study Record Dates

First Submitted

July 7, 2014

First Posted

July 10, 2014

Study Start

January 1, 2014

Primary Completion

July 1, 2015

Study Completion

August 1, 2016

Last Updated

July 22, 2020

Record last verified: 2020-07

Locations

TU(1)