Determining the effect of low-power laser therapy on midline laparotomy pain compared to placebo in upper and lower gastrointestinal surgeries

Our aim of this study is to evaluate the effect of low-power laser therapy as a complementary treatment to reduce midline laparotomy wound pain.

This clinical trial with parallel control and intervention group, double-blind, randomized groups, after obtaining written consent on 100 patients who are candidates for midline laparotomy for elective surgery ; will start. The online software www.randomizer.org was used for randomization.

Laser irradiation will be done for each patient of intervention group for 6 minutes during the first three days after the operation. first dose of radiation will be done after recovery and in the ward, and the next doses will be done at intervals of 24 hours until the third day after the operation in It will be done in hospitalization at Tehran Baqiyatallah hospital. same number of sessions for the control group will also be done with a turned off device.

In this study,100 patients (ASA I-II) with the age range of 30 to 60 years who are candidates for midline laparotomy for elective surgery of the upper and lower gastrointestinal tract were included in the study, and by lack of satisfaction, they will be excluded from the study.

The first group (control) receives the usual treatments after the operation, including intravenous and oral painkillers in case of pain, in addition to being treated with an OFF low-level laser, and the second group (study) in addition to receiving the treatments of the group First, they are treated with an ON low-level laser.

The main outcome variables of this study are evaluation the amount of pain at the midline laparotomy surgery site, the amount of serum inflammatory factors, the amount of local wound complications, in addition to assessment the amount of pain-reducing drugs in both intervention and control groups.

By Using the online software www.randomizer.org, the patients were divided into two groups of 50 people, control and intervention, in a simple and individual way. Considering that the study is double-blind; The patient and the attending physician as pain evaluators will not know whether the patients belong to the control or intervention groups.

Participants and pain evaluators, as well as the researcher of this study, by considering that the randomization of patients is done by the intervention provider, are not aware of which patient received the intervention and which patient received the placebo.

All data of this study according to the plan and after the completion of the data analysis so that the patients under study are not identifiable can be received by contacting the person in charge of scientific accountability in case of decision to publish the article in the ICMJE-related journals.

The access period starts 6 months after the publication of the article in ICMJE-related journals.

All researchers of university institutes who have published articles in ICMJE-related journals will be able to access the information of this study.

The data and analysis results of this study can only be used for inclusion in review studies.

To receive the data or the results of the analysis of this study, please refer to the person responsible for the scientific response of this study, Mr. Dr. Mohammad Madadi Imamchai, with the following contact information. Address:Baqiyatallah University of Medical Sciences, Department of General Surgery, Azam Ave, South Sheikh Bahai St, Molla Sadra Blvd, Vanak Square, Tehran. Mobile number: 00989104009204 Workplace phone number: 00982181267609 Fax number: 00982188033539 Email: geniusman68@yahoo.com Postal code: 1435915371

The request of receive information can be processed in a period of less than one week after checking the mentioned necessary conditions.