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IRCT20191103045320N2 IRCT 2022-12-21 Kashan University of Medical Sciences Comparative study of the effect of TAP (Transverse Abdominis Plane) block and anesthesia infiltration site on postoperative pain in patients with unilateral inguinal hernia repair surgery Comparative study of the effect of TAP (Transverse Abdominis Plane) block and anesthesia infiltration site on postoperative pain in patients with unilateral inguinal hernia repair surgery 2022-02-11 anticipated 63 Complete https://irct.ir/trial/60499 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple random method Randomization will be done by picking a piece of paper inside a glass by an operating room technologist with closed eyes , on the one third of the papers it is written that "Transverse Abdominis Plane block" and on the other one third it is written "local infiltration" , and on the rest of the one third it is written "control". 0 (exploratory trials) Postoperative pain. Intervention 1: Intervention group: TAP (transverse abdominis plane) Block Group, in this group local anesthetic (20 cc Bupivacaine .25 percent) will be injected in the transverse abdominis plane which is the site of the passage of the C fibers of the pain via ultrasound technique. Intervention 2: Intervention group: Local anesthesia infiltration , in this group of the intervention local anesthetic (20 cc Bupivacaine .25 percent) will be injected in the surrounding site of the surgery wound. Intervention 3: Control group: No intervention method, such as the classic and routine method, in this group no intervention in the operating room setting for the control of the post operative pain will be done. Yes - There is a plan to make this available What will be shared: The data obtained from the comparison of the two methods of TAP block and infiltration in patients in comparison with the control group will be presented in the form of published text. When: After the implementation of the plan To whom: Vice Chancellor for University Research and researchers and project consultants. Conditions: The data is usable and valuable in any outcome. Where to obtain: Vice Chancellor for Research and Technology of Kashan University of Medical Sciences. How to obtain: Necessary coordination should be provided in the Research Council of Kashan University of Medical Sciences according to the approved laws. Comments:
public Mehdi Rajabi
Kashan Imam Hossein Square
Kashan Iran (Islamic Republic of) 3791194955 +98 31 5545 3216 rajabim98@gmail.com Kashan University of Medical Sciences scientific Mehdi Rajabi
Kashan Imam Hossein Square
kashan Iran (Islamic Republic of) 3791194955 +98 31 5545 3216 rajabim98@gmail.com Kashan University of Medical Sciences Iran (Islamic Republic of) No history of drug addiction Patients with ASA grade one and two Do not take any pain medications 24 hours before surgery عدم سابقه حساسیت به بوپی واکائین Complete informed consent 18 years 70 years Both G89.18 Other acute postprocedural pain Treatment - Other Treatment - Other Other Intervention group: TAP (transverse abdominis plane) Block Group, in this group local anesthetic (20 cc Bupivacaine .25 percent) will be injected in the transverse abdominis plane which is the site of the passage of the C fibers of the pain via ultrasound technique Intervention group: Local anesthesia infiltration , in this group of the intervention local anesthetic (20 cc Bupivacaine .25 percent) will be injected in the surrounding site of the surgery wound Control group: No intervention method, such as the classic and routine method, in this group no intervention in the operating room setting for the control of the post operative pain will be done. Score of severity of the post operation pain. Timepoint: Before surgery, after admission to the recovery ward, 15 minutes after staying in the recovery ward, after admission to the surgery ward. Method of measurement: Pain is a subjective outcome, so, we ask the patients about the pain and they will score from 1 to 10 (10 = most severe). Other indicators of the pain such as hypertension, tachycardia, ECG changes, sweating, lacrimation and mydriasis will be considered. Nausea and vomiting in the post operative period setting. Timepoint: Before surgery, after admission to the recovery ward, 15 minutes after staying in the recovery ward, after admission to the surgery ward. Method of measurement: Asking from the patient, observing patient situation. Opioid consumption in the 24 hours after operation. Timepoint: Before surgery, after admission to the recovery ward, 15 minutes after staying in the recovery ward, after admission to the surgery ward. Method of measurement: Recording of the total opioid consumption in the patient document and in a piece of paper near the head of the patient. Postoperative pain (visceral pain). Timepoint: Two, four, six, twelve and twenty-four hours after surgery. Method of measurement: Visual analog scale. Deputy of research and technology Approved 2021-10-27 Ethics committee of the Kashan University of Medical Sciences Qutb Ravandi Boulevard Kashan Isfehan Iran (Islamic Republic of)