NCT03308955

Brief Summary

Laparoscopy is frequently used today for intraabdominal operations. Laparoscopic procedure has become the treatment of choice for many patients with symptomatic cholelithiasis. Patients undergoing laparoscopic cholecystectomy suffer from acute postoperative pain, despite a multimodal analgesic regime. This is a randomised controlled trial efficay of the Quadratus Lumborum (QL) Block in terms of analgesic efficacy in patients who undergo laparoscopic cholecystectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

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

August 22, 2017

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 4, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 13, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2017

Completed
Last Updated

December 29, 2017

Status Verified

December 1, 2017

Enrollment Period

Same day

First QC Date

October 4, 2017

Last Update Submit

December 27, 2017

Conditions

CholecystectomyPostoperative PainNerve Block

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Pain Scale

    Visual Analog Pain Scale was used for pain

    Postoperative 24 hours

Secondary Outcomes (3)

  • tramadol consumption

    Postoperative 24 hours

  • side effect profile scores)

    Postoperative 24 hour

  • additional analgesic use

    Postoperative 24 hour

Study Arms (2)

Grup B

ACTIVE COMPARATOR

Ultrasound guided Quadratus Lumborum block type II with 0.3 ml/kg % 0.25 bupivakain+ 400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.

Drug: TramadolProcedure: Ultrasound guided Quadratus Lumborum block

Grup S

SHAM COMPARATOR

Ultrasound guided Quadratus Lumborum block type II with 0.3 ml/kg saline % 0,9+ 400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.

Drug: TramadolProcedure: Ultrasound guided placebo Quadratus Lumborum block

Interventions

TramadolDRUG

400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.

Grup BGrup S
Ultrasound guided Quadratus Lumborum blockPROCEDURE

Ultrasound guided Quadratus Lumborum block type II with 0.3 ml/kg % 0.25 bupivakain+400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.

Grup B
Ultrasound guided placebo Quadratus Lumborum blockPROCEDURE

Ultrasound guided placebo Quadratus Lumborum block type II with 0.3 ml/kg saline % 0,9+400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.

Grup S

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who were in the American Society of Anesthesiologists (ASA) I-III class and underwent Laparoscopic Cholecystectomy

You may not qualify if:

  • Previous history of opioid use preoperatively,
  • Allergy to local anesthetics,
  • The presence of any systemic infection,
  • Uncontrolled arterial hypertension,
  • Uncontrolled diabetes mellitus.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences,,Bursa Yuksek Ihtisas Training and Research Hospital,

Bursa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Tramadol

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipids

Study Officials

  • Korgün Ökmen, M.D

    Bursa Yuksek Ihtisas Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single (Outcomes Assessor)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: prospective,randomized,single blind
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 4, 2017

First Posted

October 13, 2017

Study Start

August 22, 2017

Primary Completion

August 22, 2017

Study Completion

December 2, 2017

Last Updated

December 29, 2017

Record last verified: 2017-12

Locations

TU(1)