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Trials / Unknown

UnknownNCT05259345

Comparison of SE-TAP, M-TAPA, and Rectus Sheath Block in Abdominal Surgeries

Comparison of Subcostal Exterior Semilunaris Transverses Abdomens, Modified Thoracoabdominal Nerves Block Through Perichondrial Approach, and Rectus Sheath Block in Patients Undergoing Major Abdominal Surgeries

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Inonu University · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

The aim of this randomised controlled study is to compare the effects of three different fascial plane block \[subcostal exterior semilunaris transverses abdominis plane (SE-TAP) block, modified thoracoabdominal nerves block through perichondrial approach (M-TAPA), and rectus sheath block (RSB)\] on postoperative pain levels and opioid consumption in patients undergoing major abdominal surgeries with midline incision.

Detailed description

In last decade,ultrasound guided truncal fascial plane blocks such as transverses abdominis plane (TAP) block and rectus sheath block (RSB) have become popular as a part of postoperative multimodal analgesia for abdominal surgeries as the techniques are simple and the target sites are easily identify. Furthermore, the number of newly defined block techniques is daily increasing like M-TAPA and SE-TAP block. The rectus sheath block (RSB) is an old technique that suite midline incisions and provides analgesia for somatic pain. The local anesthetic is injected into the space between the posterior wall of the rectus abdominis muscle and its sheath, to block the anterior branches of the thoracoabdominal nerves. It has been suggested that both anterior and lateral branches of the T5-T12 thoracoabdominal nerves are blockade in M-TAPA and SE-TAP blocks. So, they may provide better analgesia and quality of recovery for major abdominal surgeries due to presence of drains. However, the extent of the local anaesthetic diffusion and the dermatomal levels are not clear, and there is no randomised clinical trial about these new techniques, to our knowledge. Patients and Methods: This is a prospective, randomised, double-blind clinical study; carry out on 120 patients schedule for elective major abdominal surgery with midline incision. While the fascia is closed, 1 g paracetamol and 1 mg/kg tramadol will be administered routinely to all patients for postoperative multimodal analgesia. At the end of surgery, patients will be randomly allocated into three groups (40 patients each); bilateral SE-TAP block in Group S, bilateral RSB in Group R, and bilateral M-TAPA block in Group M will be performed under ultrasound guidance. Patient controlled analgesia with intravenous morphine will be started at the recovery room. Postoperative pain levels, opioid consumption, and quality of recovery will be questioned and recorded at the first postoperative day.

Conditions

Interventions

TypeNameDescription
PROCEDUREBilateral SE-TAPA 20 mL of local anesthetic solution (10 mL of 5% bupivacaine + 5 mL of 2% lidocaine + 5 mL of saline) will be given between the internal oblique and transversus abdominis muscles toward the lateral border of the semilunar along the costal margin.
PROCEDUREBilateral M-TAPAA 20 mL of local anesthetic solution (10 mL of 5% bupivacaine + 5 mL of 2% lidocaine + 5 mL of saline) will be given into the layer between the transverse abdominal muscle and the inferior plane of the costal cartilage at the midclavicular line, in the sagittal plane.
PROCEDUREBilateral RSBA 20 mL of local anesthetic solution (10 mL of 5% bupivacaine + 5 mL of 2% lidocaine + 5 mL of saline) will be given between the rectus muscle and posterior rectus sheath bilaterally.

Timeline

Start date
2022-02-28
Primary completion
2024-02-28
Completion
2024-03-15
First posted
2022-02-28
Last updated
2023-04-07

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT05259345. Inclusion in this directory is not an endorsement.