Analgesic Effect of M-TAPA on LC

NCT ID: NCT05891652

Last Updated: 2023-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-11
• Study Completion Date: 2023-05-16

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.

Conditions

Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

modified thoracoabdominal nerve block through perichondrial approach

Intervention Type: PROCEDURE

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.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 78 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cumhuriyet University

OTHER

Sponsor Role: lead

Responsible Party

Oguz Gundogdu

Assisstant Professore

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sivas Cumhuriyet University

Sivas, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

M-TAPA on LC

Identifier Type: -

Identifier Source: org_study_id