NCT06008002

Brief Summary

Postoperative pain is important for patient comfort, wound healing and earlier mobilisation. Different procedures are used by clinicians for this purpose. Intravenous and regional anaesthesia techniques can be used for this purpose in patients undergoing laparoscopic cholecystectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable postoperative-pain

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

First Submitted

Initial submission to the registry

August 16, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

August 25, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2023

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2024

Completed
Last Updated

August 12, 2024

Status Verified

August 1, 2024

Enrollment Period

4 months

First QC Date

August 16, 2023

Last Update Submit

August 9, 2024

Conditions

Postoperative PainLaparoscopic CholecystectomyRegional Anesthesia

Outcome Measures

Primary Outcomes (1)

  • NRS

    The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

    Postoperative 24 hours

Secondary Outcomes (5)

  • tramadol consumption

    Postoperative 24 hours

  • side effect profile scores

    Postoperative 24 hours

  • additional analgesic use

    Postoperative 24 hours

  • pinprick test

    Postoperative 24 hours

  • Ramsay Sedation Scale

    Postoperative 24 hours

Study Arms (3)

Group M

ACTIVE COMPARATOR

ultrasound guided Modified thoracoabdominal nerves block through perichondrial approach(M-TAPA) block

Procedure: M-TAPA blockDrug: Tramadol

Group E

ACTIVE COMPARATOR

Ultrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block

Procedure: EXORA blockDrug: Tramadol

Group P

ACTIVE COMPARATOR

Patient-controlled analgesia with tramadol

Drug: Tramadol

Interventions

M-TAPA blockPROCEDURE

ultrasound guided Modified thoracoabdominal nerves block through perichondrial approach(M-TAPA) block (0.3 ml/kg , %0.25 bupivacaine) will be performed

Group M
EXORA blockPROCEDURE

Ultrasound guided External Oblique And Rectus Abdominis Plane (EXORA) Block block (0.3 ml/kg , %0.25 bupivacaine) will be performed

Group E
TramadolDRUG

400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; Patient-controlled analgesia 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.

Group EGroup MGroup P

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • laparoscopic cholecystectomy surgery
  • Patients with ASA (American Society of Anaesthetists) scores I and III will be included.

You may not qualify if:

  • Uncontrolled Arterial Hypertension
  • Uncontrolled Diabetes Mellitus,
  • Mental retardation ,
  • Antidepressant use
  • Metabolic disorders,
  • Bleeding diathesis
  • Patients with a body mass index above 30.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, 16110, 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

    Bursa Yuksek Ihtisas Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: prospective, single-blind, observational study
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 16, 2023

First Posted

August 23, 2023

Study Start

August 25, 2023

Primary Completion

December 25, 2023

Study Completion

January 13, 2024

Last Updated

August 12, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)