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IRCT20221117056529N1 IRCT 2023-03-10 Tabriz University of Medical Sciences reduce pain after laparoscopic gynecological procedures The effect of intraperitoneal spillage of rupivacaine and ketamine in combination with lung recruitment to reduce pain after laparoscopic gynecological procedures 2023-02-09 anticipated 50 Complete https://irct.ir/trial/67076 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using random numbers table, they will be randomly divided into two groups of 25 people in the study and 25 people in the control group. In such a way that in the event of odd, they would be in rupivacaine and ketamine and in the event of even, they would be in Sodium Chloride 0.9% group, Blinding description: The administration of anesthesia and fluids (volume and type of serum) during anesthesia is performed by an anesthesiologist and anesthesia technician, and all data will be collected and recorded in the checklist by an anesthesiologist who is unaware of the division of the groups. patient are also unaware of the division of the groups. 3 The effects of the combination of ropivacaine and ketamine, pain reduction, laparoscopic surgeries for women. Intervention 1: Intervention group: 50 women who have undergone laparoscopic surgery will be injected with ropivacaine 0.2% and ketamine 0.5 mg/kg in a total volume of 50 cc by the surgeon into the intraperitoneal space and the surgical site. In the control group, 50 cc of 0.09% normal saline serum will be used. Before the removal of trocars in both groups, lung recruitment maneuver will be performed. In the PACU, the patient will be monitored and treated if there is a specific complication. The severity of shoulder and abdominal pain, the degree of sedation will be recorded every 15 minutes until delivery to the ward, and in case of VAS scores higher than 3, treatment will be given, and the dose of supplementary drugs will also be recorded. Intervention 2: Control group: After surgery, 50 cc of normal saline will be used in the control group. Yes - There is a plan to make this available What will be shared: A part of the data, such as information related to the main outcome or the like, can be shared. When: Access starts from 1401 To whom: It will be available for researchers working in academic and scientific institutions and even people working in industry. Conditions: Data must be protected Where to obtain: Samin Ehsaninezhad 09364702225fu How to obtain: Immediately after calling Comments:
public Reyhane Abri
AL zahra hospital,Bagh shomal square,Artesh street
Tabriz Iran (Islamic Republic of) ۵۱۳۸۶۶۵۷۹۳ +98 41 3553 9160 reyhane.abri@gmail.com Tabriz University of Medical Sciences scientific Reyhane Abri
AL zahra hospital,Bagh shomal square,Artesh street
Tabriz Iran (Islamic Republic of) ۵۱۳۸۶۶۵۷۹۳ +98 41 3553 9160 reyhane.abri@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) II or I ASA class , candidates for laparoscopic surgery for women in the age range of 18-60 years in Al-Zahra Hospital, Tabriz Patient consent to enter the study 18 years 60 years Female The existence of any contraindications to the use of ropivacaine and other local anesthetics The presence of any contraindications for ketamine use: history of seizures, psychological disorders, hypertension, high intracerebral pressure, etc. Hypersensitivity to ropivacaine or other local anesthetics and ketamine Concomitant systemic diseases such as any history of cardiovascular, pulmonary, liver, kidney, etc. Presence of chronic pain in the patient Addiction to the use of painkillers and drugs Patient dissatisfaction T88.9 Complication of surgical and medical care, unspecified Treatment - Drugs Placebo Intervention group: 50 women who have undergone laparoscopic surgery will be injected with ropivacaine 0.2% and ketamine 0.5 mg/kg in a total volume of 50 cc by the surgeon into the intraperitoneal space and the surgical site. In the control group, 50 cc of 0.09% normal saline serum will be used. Before the removal of trocars in both groups, lung recruitment maneuver will be performed. In the PACU, the patient will be monitored and treated if there is a specific complication. The severity of shoulder and abdominal pain, the degree of sedation will be recorded every 15 minutes until delivery to the ward, and in case of VAS scores higher than 3, treatment will be given, and the dose of supplementary drugs will also be recorded. Control group: After surgery, 50 cc of normal saline will be used in the control group. The percentage of people in whom abdominal and shoulder pain has decreased after laparoscopic surgeries. Timepoint: Upon entering the operating room, standard monitoring including NIBP, HR, RR, ECG, SPO2, and ETCo2 is done and will continue. The severity of shoulder and abdominal pain is recorded every 15 minutes until the patient's complete recovery and delivery to the ward. Method of measurement: The severity of shoulder and abdominal pain, based on VAS score and degree of sedation according to Ramsay sedation score, is recorded every 15 minutes until the patient's complete recovery and delivery to the ward. Tabriz University of Medical Sciences Approved 2022-07-12 Ethics committee of Tabriz Medical Sciences Talash dormitory ,Pish ghadam,kamar bandiye miyani Tabriz East Azarbaijan Iran (Islamic Republic of)