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Comparing the Effects of M-TAPA and TAP Block on Postoperative Analgesia in TAH

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
M-TAPA block
TAP block
Sponsored by
Cumhuriyet University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Postoperative Pain focused on measuring m-tapa, tap block, total abdominal hysterectomy, regional anesthesia, postoperative pain

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Adult patients older than 35 years of age who underwent open total abdominal hysterectomy 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 laparoscopic 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 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

M-TAPA block

TAP block

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

Control group patients were not subjected to any block or local infiltration anesthesia. Their postoperative pain was relieved with tramadol (intravenous) administration.

Outcomes

Primary Outcome Measures

Comparing the 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

Comparing total tramadol consumption
Postoperative analgesic need

Full Information

First Posted
June 1, 2023
Last Updated
June 12, 2023
Sponsor
Cumhuriyet University
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1. Study Identification

Unique Protocol Identification Number
NCT05901090
Brief Title
Comparing the Effects of M-TAPA and TAP Block on Postoperative Analgesia in TAH
Official Title
Comparing the Effects of Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) and Transerversus Abdominis Plane Block (TAP) on Postoperative Pain Scores and Total Analgesic Consumption in Patients Ongoing Total Abdominal Hysterectomy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 12, 2023 (Actual)
Primary Completion Date
May 25, 2023 (Actual)
Study Completion Date
June 1, 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
Yes

5. Study Description

Brief Summary
Aim is to compare the postoperative analgesic efficacy of M-TAPA block and TAP block and their effect on opioid consumption in patients undergoing open total abdominal hysterectomy (TAH) surgery.
Detailed Description
There were three randomized groups: Group M (M-TAPA block) (n=15), Group T (TAP block) (n=15) and Group C (no block) (n=15). All patients had standard general anesthesia. Group M had bilateral M-TAPA block with 0.25% bupivacaine (total volume of 40 ml) at the end of the surgery. Group T patients had TAP block with 0.25% bupivacaine (total volume of 40 ml) at the end of the surgery. Group Control had only tramadol for postoperative pain. Numerical rating scale (NRS) was used to assess postoperative pain on 1st, 6th, 12th and 24th hour after the surgery. Total tramadol consumption was calculated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
m-tapa, tap block, total abdominal hysterectomy, regional anesthesia, postoperative pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
M-TAPA block
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
TAP block
Arm Type
Active Comparator
Arm Description
Patients had bilateral TAP 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
Control group patients were not subjected to any block or local infiltration anesthesia. Their postoperative pain was relieved with tramadol (intravenous) administration.
Intervention Type
Other
Intervention Name(s)
M-TAPA block
Other 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. M-TAPA block with the same standard technique and drug dose was applied to the contralateral side for each group of M-TAPA patients.
Intervention Type
Other
Intervention Name(s)
TAP block
Other Intervention Name(s)
Transversus abdominis plane block
Intervention Description
After the necessary sterilization conditions were established, the linear ultrasound probe was sterilely coated and placed in the middle of the iliac crest with the end limit of the ribs. Starting with skin, the layers in descending order, subcutaneous adipose tissue, external oblique muscle, internal oblique muscle, transversus abdominis muscle, and peritoneum were identified. As the tip of the 80 mm sonovisible needle passed through the muscular layers and fascia, a fascial click was felt and the needle was advanced with ultrasound in a controlled manner. After receiving the second click sensation (passage of the fascia of the internal oblique muscle), the location of the needle was fixed and frequently aspirated and applied to the plane so that 20 ml of 0.25% bupivacaine was applied to each side. (40 ml in total)
Primary Outcome Measure Information:
Title
Comparing the 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
Comparing total tramadol consumption
Description
Postoperative analgesic need
Time Frame
Postoperative 24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients older than 35 years of age who underwent open total abdominal hysterectomy 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 laparoscopic surgery, patients with unstable hemodynamics, patients who could not cooperate during postoperative pain assessment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oğuz Gündoğdu
Organizational Affiliation
Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sivas Cumhuriyet University
City
Sivas
ZIP/Postal Code
58000
Country
Turkey

12. IPD Sharing Statement

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Comparing the Effects of M-TAPA and TAP Block on Postoperative Analgesia in TAH

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