Analgesic Effect of M-TAPA on LC

• Sponsor: Cumhuriyet University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05891652
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.1
• Patients Per Site Per Month: 36.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Post Operative Pain	Procedure: modified thoracoabdominal nerve block through perichondrial approach	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Intervention 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.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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Apr 11, 2023
• Actual Primary Completion Date: May 12, 2023
• Actual Study Completion Date: May 16, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Blocked 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.	Procedure: modified thoracoabdominal nerve block through perichondrial approach; 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.
No Intervention: Control Patients did not have any block or infiltration anesthesia for their postoperative pain. They only received intravenous opioid analgesic (tramadol).

Outcome Measures

Primary Outcome Measures

1. numerical rating scale scores [postoperative 24 hours]

   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

1. total tramadol consumption [postoperative 24 hours]

   postoperative analgesic need

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 78 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sivas Cumhuriyet University	Sivas		Turkey	58000

Sponsors and Collaborators

• Cumhuriyet University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Oguz Gundogdu, Assisstant Professore, Cumhuriyet University
• ClinicalTrials.gov Identifier: NCT05891652
• Other Study ID Numbers: M-TAPA on LC
• First Posted: Jun 7, 2023
• Last Update Posted: Jun 7, 2023
• Last Verified: May 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
• Keywords provided by Oguz Gundogdu, Assisstant Professore, Cumhuriyet University: modified thoracoabdominal nerve block through perichondrial approach; postoperative pain; laparoscopic cholecystectomy
• Additional relevant MeSH terms: Pain, Postoperative

Study Results

No Results Posted as of Jun 7, 2023