An interventional study of Bilateral SE-TAP and Bilateral M-TAPA in Postoperative Pain, sponsored by Inonu University. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-04-07.
Sponsored by Inonu University · Not applicable, Interventional, and Treatment
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.
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's planned enrollment of 40 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Inonu University is the lead sponsor of 375 studies on the registry; 86 are open to participants now.
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Exclusion Criteria:
Bilateral subcostal exterior semilunaris transverses abdominis plane (SE-TAP) block will be performed with 20 mL of local anesthetic solution (10 mL of 5% bupivacaine + 5 mL of 2% lidocaine + 5 mL of saline)
Procedure: Bilateral SE-TAP
Bilateral modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) will be performed with 20 mL of local anesthetic solution (10 mL of 5% bupivacaine + 5 mL of 2% lidocaine + 5 mL of saline)
Procedure: Bilateral M-TAPA
Bilateral rectus sheath block will be performed with 20 mL of local anesthetic solution (10 mL of 5% bupivacaine + 5 mL of 2% lidocaine + 5 mL of saline)
Procedure: Bilateral RSB
A 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.
Also known as: Ultrasound guided bilateral subcostal exterior semilunaris transversus abdomens plane block
A 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.
Also known as: Ultrasound guided bilateral modified thoracoabdominal nerves block through perichondrial approach (M-TAPA)
A 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.
Also known as: Ultrasound guided bilateral rectus sheath block
Quality of Recovery
Quality of Recovery-40 (QoR-40), a 40-item questionnaire that provides a global score and subscores across five dimensions; patient support, comfort, emotions, physical independence, and pain (minimum score of 40 and maximum of 200).
Time frame: At postoperative 24th hours
Postoperative pain
Numeric rating scale pain from 0 (no pain) to 10 (worst pain).
Time frame: At postoperative 48 hours (2.,6.,12.,18.,24.,48.hours)
Opioid consumption
Morphine consumption
Time frame: At postoperative 48 hours (2.,6.,12.,18.,24.,48.hours)
Plan to share: No
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Inonu University