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

NCT ID: NCT05901090

Last Updated: 2023-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-12
• Study Completion Date: 2023-06-01

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

M-TAPA block

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

M-TAPA block

Intervention Type: OTHER

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.

TAP block

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

Group Type: ACTIVE_COMPARATOR

TAP block

Intervention Type: OTHER

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)

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

M-TAPA block

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

TAP block

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)

Intervention Type: OTHER

Other Intervention Names

Modified thoracoabdominal nerve block through perichondrial approach; Transversus abdominis plane block

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cumhuriyet University

OTHER

Sponsor Role: lead

Responsible Party

Oguz Gundogdu

Assisstant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oğuz Gündoğdu

Role: PRINCIPAL_INVESTIGATOR

Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation

Locations

Sivas Cumhuriyet University

Sivas, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

M-TAPA vs TAP block on TAH

Identifier Type: -

Identifier Source: org_study_id