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Analgesic Effect of M-TAPA on LC

Primary Purpose

Post Operative Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
modified thoracoabdominal nerve block through perichondrial approach
Sponsored by
Cumhuriyet University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring modified thoracoabdominal nerve block through perichondrial approach, postoperative pain, laparoscopic cholecystectomy

Eligibility Criteria

19 Years - 78 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult patients older than 18 years of age who underwent elective laparoscopic cholecystectomy under general anesthesia and were American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification. Exclusion Criteria: Patients who did not give consent, patients with coagulopathy, patients with signs of infection at the block application site, patients using anticoagulants, patients with local anesthetic drug allergies, patients undergoing open surgery, patients with unstable hemodynamics, patients who could not cooperate during postoperative pain assessment

Sites / Locations

  • Sivas Cumhuriyet University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Blocked

Control

Arm Description

Patients had bilateral M-TAPA block with 0.25% bupivacaine (total volume of 40 ml) at the end of the surgery for postoperative pain control.

Patients did not have any block or infiltration anesthesia for their postoperative pain. They only received intravenous opioid analgesic (tramadol).

Outcomes

Primary Outcome Measures

numerical rating scale scores
numerical rating scale is used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome.

Secondary Outcome Measures

total tramadol consumption
postoperative analgesic need

Full Information

First Posted
May 16, 2023
Last Updated
May 26, 2023
Sponsor
Cumhuriyet University
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1. Study Identification

Unique Protocol Identification Number
NCT05891652
Brief Title
Analgesic Effect of M-TAPA on LC
Official Title
The Effects of Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) on Postoperative Pain and Analgesic Consumption in Patients Undergoing Laparoscopic Cholecystectomy: a Randomized Double-blind Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 11, 2023 (Actual)
Primary Completion Date
May 12, 2023 (Actual)
Study Completion Date
May 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cumhuriyet University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Objective: To investigate the postoperative analgesic efficacy of M-TAPA block and its effect on opioid consumption in patients undergoing laparoscopic cholecystectomy (LC) surgery. Place and Duration of Study: Department of Anesthesiology and Reanimaton, Sivas Cumhuriyet University, Sivas, Turkey, from April 2023 to May 2023. Methodology: There were two randomized groups: Group M-TAPA (n=21) and Group Control (no block) (n=21). All patients had standard general anesthesia. Group M-TAPA patients had bilateral M-TAPA block with 0.25% bupivacaine (total volume of 40 ml) at the end of the surgery. Group Control had only tramadol for posteperative pain. Numerical rating scale (NRS) and visual analogue scale (VAS) were used to assess postoperative pain. Total tramadol consumption was calculated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
modified thoracoabdominal nerve block through perichondrial approach, postoperative pain, laparoscopic cholecystectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
There were two randomized groups: Group M-TAPA (n=21) and Group Control (no block) (n=21). All patients had standard general anesthesia. Group M-TAPA patients had bilateral M-TAPA block with 0.25% bupivacaine (total volume of 40 ml) at the end of the surgery. Group Control had only tramadol for posteperative pain.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blocked
Arm Type
Active Comparator
Arm Description
Patients had bilateral M-TAPA block with 0.25% bupivacaine (total volume of 40 ml) at the end of the surgery for postoperative pain control.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients did not have any block or infiltration anesthesia for their postoperative pain. They only received intravenous opioid analgesic (tramadol).
Intervention Type
Procedure
Intervention Name(s)
modified thoracoabdominal nerve block through perichondrial approach
Intervention Description
Following sterile conditions for bilateral M-TAPA block application, the transducer was inserted on the chondrium in the sagittal plane at the 9-10th rib level. Subsequently, a deep angle was created with the probe for visualization of the underside of the costochondrium. The sonovisible needle tip was placed just below the chondrium and saline (5 ml) was injected for site confirmation. After the confirmation, 20 ml of 0.25% bupivacaine was administered for each group for a total of 40 ml of local anesthetic. Blocks were applied using an 80 mm sonovisible needle with a 6-10 MHz linear probe under the guidance of a portable ultrasound. Same procedure applied to the contralateral side.
Primary Outcome Measure Information:
Title
numerical rating scale scores
Description
numerical rating scale is used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome.
Time Frame
postoperative 24 hours
Secondary Outcome Measure Information:
Title
total tramadol consumption
Description
postoperative analgesic need
Time Frame
postoperative 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients older than 18 years of age who underwent elective laparoscopic cholecystectomy under general anesthesia and were American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification. Exclusion Criteria: Patients who did not give consent, patients with coagulopathy, patients with signs of infection at the block application site, patients using anticoagulants, patients with local anesthetic drug allergies, patients undergoing open surgery, patients with unstable hemodynamics, patients who could not cooperate during postoperative pain assessment
Facility Information:
Facility Name
Sivas Cumhuriyet University
City
Sivas
ZIP/Postal Code
58000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
23/09/2023

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Analgesic Effect of M-TAPA on LC

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