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Modified Thoracoabdominal Nerve Block(M-TAPA) in Total Laparoscopic Hysterectomies

G

Gulhane Training and Research Hospital

Status

Invitation-only

Conditions

Pain,Postoperative

Treatments

Other: M-TAPA Block
Other: Trocar site local anesthetic infiltration

Study type

Interventional

Funder types

Other

Identifiers

NCT06601413
2023-KAEK-159

Details and patient eligibility

About

The aim of the study is comparing the postoperative effects of ultrasound-guided Modified Perichondrial Approach to Thoracoabdominal Nerves (M-TAPA) block for postoperative pain control after total laparoscopic hysterectomy.

Full description

Pain is one of the most common problems seen in the postoperative period in patients who underwent total laparoscopic hysterectomy.

Multimodal analgesia methods are used in postoperative pain management. Nerve blocks, which are an important component of multimodal analgesia, have an important place in postoperative analgesia management today.

Local Anesthetic Infiltration at the Trocar Site is the most classical nerve block method that has been used for a long time as a part of multimodal analgesia in laparoscopic surgeries.

Modified TAPA block applied with ultrasound guidance; It is a regional block affecting both the anterior and lateral branches of the thoracoabdominal nerves with a perichondrial approach. It is used in total laparoscopic hysterectomies.

Enrollment

66 estimated patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Ages 18-65
  • Elective cases
  • ASA I-III functional status
  • Body mass index (BMI)<35
  • Total laparoscopic hysterectomy planned with general anesthesia
  • No contraindications for M-TAPA block to be applied
  • Cases that give written and verbal consent for participation in the study will be included.

Exclusion criteria

  • Conversion to open surgery
  • Development of perioperative complications (due to surgery and/or anesthesia)
  • Coagulation disorder
  • Infection at the injection site
  • Allergy to local anesthesia
  • Those who used any painkillers in the preoperative 24 hours
  • Those who did not agree to participate in the study

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

66 participants in 2 patient groups, including a placebo group

M-TAPA Group
Active Comparator group
Description:
At the end of the surgery, without waking the patient, a linear transducer will be placed on the costochondral angle in the sagittal plane under ultrasound guidance, and a total of 40 mL of LA (0.25% Bupivacaine) will be applied bilaterally to the lower surface of the chondrium, giving a deep angle to see the lower side of the chondrium centrally.
Treatment:
Other: M-TAPA Block
Trochar-site Group
Placebo Comparator group
Description:
At the end of surgery, infiltration analgesia will be applied by the surgeon to all trocar entry sites (4 port entries) with 10 ml of 0.25% bupivacaine (40 mL in total) without waking the patient.
Treatment:
Other: Trocar site local anesthetic infiltration

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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