Clinical trial NCT06423456
Conditions: Postoperative Pain Postoperative Nausea Analgesia
Keywords: hysteroscopy intraoperative lidocaine postoperative pain postoperative nausea
Sponsor: Afyonkarahisar Health Sciences University
Start date: 2024-03-01; Completion date: 2025-02-24
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Intraoperative lidocaine infusion is a frequently preferred method in surgical procedures due to its reducing the need for opioids, providing better postoperative pain control, reducing postoperative nausea and vomiting and increasing rapid recovery. Our aim in this study is to show the effect of intraoperative lidocaine infusion on reducing complications such as pain, nausea, vomiting, and the need for opioid analgesia that occur after hysteroscopy operations, which are often performed in gynecology clinics.

Detailed description:
Hysteroscopy abnormal uterine bleeding, infertility, endometrial pathologies, uterine fibroids,it is a method that is often used in the diagnosis and treatment of pathologies such as intrauterine synechia.

Hysteroscopy; observation of the inner layer of the uterus with a special optical instrument with a cold light source and it is the process of making intrauterine interventions using small hand tools. General anesthesia or with intrauterine fluid after dilating the cervix under regional (epidural/peridural) anesthesia it is filled and a thin telescope-like optical device (hysteroscope) is transmitted into the uterus. This way the uterine cavity is observed. Hysteroscopy is used for diagnostic purposes as well as for therapeutic purposes it can be applied.

General Anesthesia (GA) is often the preferred method for operative hysteroscopy.Intraoperative lidocaine infusion reduces the need for opioids, postoperative pain control is better due to the fact that it reduces postoperative nausea, vomiting and increases rapid recovery, which is often preferred in surgical procedures. 150 patients who are scheduled to undergo hysteroscopy will be included in the study. Hysteroscopy the patients to be applied will be divided into two groups as research and control groups. To both groups 75 patients will be included each. General anesthesia during the procedure for patients in the research arm intravenous lidocaine of 0.15 ml/kg 1% will be administered intraoperatively before and during the procedure a 1% lidocaine infusion(at a dose of 0.2 ml/kg/hour) will be performed. In the control group, if 0.9% saline solution will be used instead of lidocaine.

Pain measurement using visual analog scale (VAS) for postoperative pain after surgery will be done. At the same time, intraoperative analgesic use of patients, postoperative nausea-vomiting and antiemetic uses will be recorded.

Arms: arm 1: During the procedure, intravenous lidocaine of 0.15 ml/kg 1% will be administered intraoperatively before general anesthesia and infusion of lidocaine of 1%(at a dose of 0.2 ml/kg/hour) will be performed during the procedure. arm 2: In the control group, 0.9% saline solution will be used instead of lidocaine.
Interventions: intervention 1: Lidocaine IV intervention 2: Saline
Intervention descriptions: intervention 1: Pain measurement will be performed using a visual analog scale (VAS) for postoperative pain after the operation. At the same time, patients' intraoperative analgesic use, postoperative nausea-vomiting and antiemetic use will be recorded. intervention 2: Pain measurement will be performed using a visual analog scale (VAS) for postoperative pain after the operation. At the same time, patients' intraoperative analgesic use, postoperative nausea-vomiting and antiemetic use will be recorded.

Protocol documents:
ICF_002.pdf: 
 
THE IMPACT OF INTRAOPERATIVE LIDOCAINE INFUSION ON 
POSTOPERATIVE RECOVERY AFTER HYSTEROSCOPY:  
A RANDOMIZED CONTROLLED TRIAL 
 
 
INFORMED CONSENT FORM 
26th FEBRUARY 2024 
 


 
INFORMED VOLUNTARY CONSENT FORM 
The study you are participating in is a scientific research and the name of the 
research is "The effectiveness of intravenous lidocaine treatment in post-operative 
pain control in patients undergoing hysteroscopy." 
Hysteroscopy is a frequently used method in the diagnosis and treatment of 
pathologies such as abnormal uterine bleeding, infertility, endometrial pathologies, 
uterine fibroids, and intrauterine synechia. General Anesthesia (GA) is the frequently 
preferred method in operative hysteroscopy. Intraoperative lidocaine infusion is a 
frequently preferred method in surgical procedures because it reduces the need for 
opioids, provides better postoperative pain control, reduces postoperative nausea and 
vomiting, and increases rapid recovery. This method has been shown to reduce 
complications such as postoperative pain after procedures such as endoscopic 
submucosal dissection and laparoscopic cholecystectomy. Our aim in this study is to 
show the effect of intraoperative lidocaine infusion in reducing complications such as 
pain, nausea, vomiting, and opioid analgesia requirement after hysteroscopy 
operations frequently performed in gynecology clinics. Participation in this study is 
entirely voluntary. You may decline to participate in the study; this situation will not 
lead to any penalty or hindrance to your benefits. The results of the research will be 
used for scientific purposes. Medical data about you may also be used for scientific 
purposes if necessary. 
You can leave the study at any time. Your information will not be shared with 
anyone in any way. You can reach the doctors involved in the study from our 
hospital's phone number 05467240341. 
All your medical and identity information will be kept confidential and your 
identity information will not be given even if the study is published, but the audience 
of the study, those conducting the examination, ethics committees and official 
authorities can access your medical information when necessary. You can also access 
your own medical information whenever you want. 
 
Consent to Participate in the Study: 
I have read and listened to the information provided above, which should be 
given to the volunteer before starting the research. I have asked the researcher all the 
questions that come to my mind, and I have understood in detail all the explanations 
given to me in written and verbal form. I have been given sufficient time to decide 
whether I want to participate in the study. Under these conditions, I authorize the 
researcher to review, transfer and process my medical information, and I accept the 
invitation to participate in the study voluntarily, without any coercion or pressure. 
 
A signed copy of this form will be given to me. 
 

Prot_000.pdf: 
1 
 
THE IMPACT OF INTRAOPERATIVE LIDOCAINE INFUSION 
ON POSTOPERATIVE RECOVERY AFTER HYSTEROSCOPY: 
A RANDOMIZED CONTROLLED TRIAL 
 
Betul AHAT, M.D. 
Afyonkarahisar University of Health Sciences  
Medical School Hospital 
Department of Obstetrics and Gynecology  
November 2024 
Supervisor: Assistant Professor Rıza DUR 
 
 
Introduction: Hysteroscopy is a surgical method which is frequently used for the 
diagnosis and treatment of intrauterine pathologies including adhesions, polyps and 
endometrial hyperplasia. This procedure can be performed at the office without 
anesthesia or at the surgery room under anesthesia.  
Purpose: This study aims to investigate the efficiency of intraoperative lidocaine 
infusion, which is frequently preferred for surgical procedures, in reducing 
postoperative pain, nausea, and vomiting, as well as the need for opioid analgesics and 
anti-emetics. 
Methods: This is a prospective review of 150 patients who have consecutively 
undergone elective hysteroscopy for various indications. The patients aged <18 years 
and >65 years, the patients with body mass indices < 18.5 kg/m² or ≥ 25 kg/m2, the 
patients with American Society of Anesthesiologists physical status >II, the patients 
with a history of allergy to local anesthetics, the patients with chronic pain syndromes, 
the patients who had long-term analgesic and sedative use, the patients with opioid 
dependence, and the patients severe arrhythmia, organic heart disease, and mental or 
neurological disorders were excluded.  
The participants were randomly assigned to the study group (lidocaine) or the control 
group (saline) using a computer-generated randomization sequence. Thus, 75 patients 
were allocated to either research or control groups. The patients in the research group 
received 1% intravenous lidocaine at a dose of 0.15 ml/kg before the initiation of 
general anesthesia and the infusion of 1% lidocaine would be continued at a dose of 


2 
 
0.2 ml/kg/hour throughout the procedure. In the control group, 0.9% saline solution 
would be used instead of lidocaine. Both the patients and the healthcare providers 
administering the interventions were blinded to the allocation. 
The primary endpoint was the postoperative pain assessed by Visual Analog Scale 
(VAS) at 30th minute, 60th minute, 4th hour, and 24th hour. Secondary endpoints 
included nausea, vomiting, need for analgesic and anti-emetic drugs during the 
postoperative period. 
 

SAP_001.pdf: 
 
THE IMPACT OF INTRAOPERATIVE LIDOCAINE INFUSION ON 
POSTOPERATIVE RECOVERY AFTER HYSTEROSCOPY:  
A RANDOMIZED CONTROLLED TRIAL 
 
 
STATISTICAL ANALYSIS PLAN 
24th  DECEMBER 2024 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
STATISTICAL ANALYSIS PLAN 


 
Collected data were analyzed using Statistical Package for Social Sciences version 
25.0 (SPSS, IBM Armonk, NY, USA). Kolmogorov-Smirnov test was used to test data 
distribution. Continuous variables were expressed as mean ± standard deviation and 
categorical variables were presented as frequencies and percentages where 
appropriate. Student’s t-test was used to compare the continuous variables of the study 
and control groups whereas chi-square test was used to compare the categorical 
variables of the study and control groups. Two-tailed p values less than 0.05 were 
accepted as statistically significant. 
 
A post hoc analysis was carried out to make a retrospective power analysis and it was 
determined that a cohort size of 150 women (75 patients in the study group and 75 
patients in the control group) had 87.6 % power to detect a difference at the 0.05 
significance level.