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Evaluation of the Efficacy of Regional Anaesthesia for Analgesia After Laparoscopic Cholecystectomy

Sponsor
Bursa Yüksek İhtisas Education and Research Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06008002
Collaborator
(none)
90
Enrollment
3
Arms
4.6
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

In our study, the investigators aimed to investigate the effectiveness of different methods applied for post-operative pain in patients undergoing laparoscopic cholecystectomy surgery.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
prospective, single-blind, observational studyprospective, single-blind, observational study
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Evaluation of the Efficacy of M-TAPA and EXORA Block Application for Analgesia After Laparoscopic Cholecystectomy; Prospective, Single-blind, Observational Study
Anticipated Study Start Date :
Aug 25, 2023
Anticipated Primary Completion Date :
Dec 25, 2023
Anticipated Study Completion Date :
Jan 13, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group M

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

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

Drug: Tramadol
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.
Active Comparator: Group E

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

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

Drug: Tramadol
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.
Active Comparator: Group P

Patient-controlled analgesia with tramadol

Drug: Tramadol
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.

Outcome Measures

Primary Outcome Measures

  1. NRS [Postoperative 24 hours]

    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"

Secondary Outcome Measures

  1. tramadol consumption [Postoperative 24 hours]

  2. side effect profile scores [Postoperative 24 hours]

    1. Nausea and vomiting scale (nausea-vomiting scale (NVS): No nausea is present, Mild nausea is present. Severe nausea is present. Vomiting is present) In case of a NVS score of >3, an anti-emetic drug was administered.

  3. additional analgesic use [Postoperative 24 hours]

    additional analgesic use

  4. pinprick test [Postoperative 24 hours]

    The level of sensory block will be evaluated by pinprick test at 30 minutes following the block procedure and in postoperative patients. With the pinprick, the gently touches the skin with the pin or back end and asks the patient whether it feels sharp or blunt.

  5. Ramsay Sedation Scale [Postoperative 24 hours]

    Ramsay Sedation Scale (RSS) : Anxiety, agitation are present; Cooperated,awake; Sedated , response to commands; Sleepy, immediately awoken by auditory stimulus or glabella tap; Sleepy, deep response to auditory stimulus or glabella tap and Sleepy, no response to auditory stimulus or glabella tap )

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • laparoscopic cholecystectomy surgery

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

Exclusion Criteria:

  • Uncontrolled Arterial Hypertension

  • Uncontrolled Diabetes Mellitus,

  • Mental retardation ,

  • Antidepressant use

  • Metabolic disorders,

  • Bleeding diathesis

  • Patients with a body mass index above 30.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Bursa Yüksek İhtisas Education and Research Hospital

Investigators

  • Principal Investigator: Korgün Ökmen, University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Korgün Ökmen, Principal Investigator, Bursa Yüksek İhtisas Education and Research Hospital
ClinicalTrials.gov Identifier:
NCT06008002
Other Study ID Numbers:
  • 2023-3/1
First Posted:
Aug 23, 2023
Last Update Posted:
Aug 25, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pain, Postoperative
Tramadol

Study Results

No Results Posted as of Aug 25, 2023