An interventional study of Midpoint transverse process block group and Sham group in Pre-emptive, Postoperative Pain and Thoracotomy, sponsored by Tanta University. Status unknown at 1 site in Egypt. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-10-01.
Sponsored by Tanta University · Not applicable, Interventional, and Treatment
This study is designed to investigate the analgesic efficacy of pre-emptive ultrasound-guided midpoint transverse process to pleura (MTP) block for posterolateral thoracotomy in cardiothoracic surgeries.
Preemptive preoperative analgesia was first proposed, over the years it has been gradually regarded as an intervention given before incision, facilitating mobilization and functional rehabilitation after surgery, reducing postoperative opioid consumption, decreasing the incidence of adverse events and improving patient satisfaction.
The Mid Transverse Process to Pleura block, described by Costach et al. involves deposition of drug midway between the transverse process and pleura. Costach et al. postulated that the local anesthetic deposited at this point may reach the paravertebral space through several possible mechanisms, such as spread medially through the gap between the superior costotransverse ligament (SCTL) and vertebral bodies, through fenestrations in SCTL, and laterally through the internal intercostal membrane
5,093 studies on the registry are indexed under Pain, Postoperative; 1,137 are open to participants now.
This study's planned enrollment of 70 is close to the median of 75 across 4,341 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Patients will receive midpoint transverse process block after induction of general anesthesia and before surgical incision
Procedure: Midpoint transverse process block group
Patients will receive general anesthesia and the same intervention steps will be performed i.e., the block under investigation but instead of local anesthetic a placebo (2ml normal saline) will be injected (sham block)
Procedure: Sham group
After marking the level of the incision by surgeon (commonly T5- T6) The patient will be situated in the lateral position, the block area will be sterilized with povidine-iodine, and high -frequency linear ultrasound probe will be placed oblique parasagittally 3 cm lateral to the spinous process at the level of skin incision. 100-mm short bevel echogenic needle (Contiplex, B.Braun, Germany) will be inserted in plane from cranial to caudal direction. The desired end point of the needle tip will be the midpoint of the line between the posterior border of transverse process and the pleura titrated bolus of 20 ml of 0.25% bupivacaine and dexamethazone 8 mg will be injected at the target site. At end of the surgery general anaesthesia will be stopped with reversal of muscle relaxation and awakening of patient
General anesthesia will be induced with the same protocol and MTP block will be done but with injection of placebo (2 ml normal saline) instead of local anesthetic . On arrival to the PACU postoperative Numerical Rating scale at rest and coughing will be recorded, analgesia will be maintained with intravenous paracetamol 1 g every 8 h and required additional rescue analgesia (morphine) at any time will be calculated.
The degree of Postoperative Pain
Postoperative pain will be assessed by the Numerical Rating Scale (NRS;0 no pain while 10 is the maximum pain) at 0,4,8,12,18, 24 hours during rest and cough. If the (NRS) is 4 or more, morphine 3mg will be titrated until pain relief is achieved using a short interval between boluses
Time frame: 24 hours postoperative
The amount of Postoperative morphine consumption
Total morphine consumption at 24 hours after surgery
Time frame: 24 hours Postoperative
Time to the first rescue analgesia request
Time till administration of first rescue analgesia
Time frame: 24 hours Postoperative
SpO2/FiO2 ratio
SpO2/FiO2 ratio at 6,8,12 and 24h postoperatively
Time frame: 24 hours Postoperative
Plan to share: Yes — The data will be available upon reasonable request from the principal investigator
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Tanta University