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

Modified Thoracoabdominal Nerves Block Through Perichondrial Approach (M-TAPA) Versus Incisional Local Anesthetic Administration for Total Laparoscopic Hysterectomy : a Prospective, Randomized Clinical Study

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06601413
Enrollment
66
Registered
2024-09-19
Start date
2024-10-01
Completion date
2025-02-01
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain,Postoperative

Keywords

M-TAPA, post-operative pain,, Total laparoscopyc histerectomy

Brief summary

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.

Detailed 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.

Interventions

M-TAPA block will administer ultrasound guided (Sonosite, Inc., Bothell, WA, USA) bilaterally by same anesthesiologist (E.E.) who had more than 10 years experience of regional anesthesia, before weaking from general anesthesia after the surgical procedure. A high-frequency (6-13 MHz) linear probe (HFL38) will be used to identify the transversus abdominis, internal oblique, and external oblique muscles on the costochondral angle in the sagittal plane at the 10th costal margin. In the midclavicular line, between the upper fascia of the transversus abdominis muscle and the lower fascia of the costochondral tissue, at the level of the 10th rib, 20 mL of 0.25 percent bupivacaine will be injected (arcus costarum). The same procedure will be followed on the other side.

OTHERTrocar site local anesthetic infiltration

At the end of surgery, infiltration analgesia will be applied to all trocar entry sites (4 port entries) by the surgeon with 10 ml of 0.25% bupivacaine (40 mL in total) without waking the patient.

Sponsors

Gulhane Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative total tramadol consumption for first 24 hoursPostoperative 24 hoursThe intravenous PCA pump will be programmed to deliver a bolus of 20 mg tramadol with a lockout interval of 30 min and no baseline infusion (tramadol 500 mg in 100 mL SF

Secondary

MeasureTime frameDescription
Postoperative pain scoresat postoperative 0 (PACU), 1, 2, 4, 8, 12 and 24 hoursPain will be assessed with visual analog score (VAS) in 2 different ways, at rest and with movement (VAS: 0, no pain; 10, worst pain imaginable). VAS scores will be recorded at postoperative 0 (PACU), 1, 2, 4, 8, 12 and 24 hours

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026