About this trial
The purpose of this study is to determine whether laparoscopic spraying combined with intravenous injection of lidocaine can improve pain in patients undergoing laparoscopic myomectomy under general anesthesia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age:18-65 years old;
ASA physical status classification I - III;
Undergoing laparoscopic hysteromyoma resection under general anesthesia;
The patient has been informed and has signed the informed consent form.
Disqualifiers
Surgery duration exceeding 3 hours;
Need for additional surgery;
Allergy to the study drugs;
Presence of severe psychological,hepatic,renal,and cardiac diseases;
Trial design
Parallel
Treatments tested in this trial
Saline
Drug10 minutes before the infusion saline 1.5mg/kg was administered to the patient. Subsequnetly, a continuous intravenous infusion saline 2mg/kg/h was maintained until the end of the sugery. Before closing the abdominal cavity, 20ml normal saline was administered.
intravenous +saline lidocaine
Drug10 minutes before the infusion 2% lidocaine 1.5mg/kg was administered to the patient. Subsequnetly, a continuous intravenous infusion 2% lidocaine 2mg/kg/h was maintained until the end of the sugery. Before closing the abdominal cavity, 20ml normal saline was administered.
saline + intraperitoneal lidocaine
Drug10 minutes before the infusion saline 1.5mg/kg was administered to the patient. Subsequnetly, a continuous intravenous infusion saline ( 2mg/kg/h) was maintained until the end of the sugery. Before closing the abdominal cavity, 2% lidocaine (4-5mg/kg) + 1/200,000 epinephrine was spraged into the abdominal cavity.
intravenous + intraperitoneal lidocaine
Drug10 minutes before the infusion 2% lidocaine (1.5mg/kg) was administered to the patient. Subsequnetly, a continuous intravenous infusion 2% lidocaine ( 2mg/kg/h) was maintained until the end of the sugery. Before closing the abdominal cavity, 2% lidocaine (4-5mg/kg) + 1/200,000 epinephrine was spraged into the abdominal cavity.
Treatment groups
Trial outcomes
Primary outcomes
The incidence rate of moderate to severe pain within 24 hours
Pain severity was measured using The NRS((Numerical Rating Scale),The NRS≥4 was considered moderate to severe pain. If the NRS score is greater than or equal to 4 at least once within 24 hours, it is considered moderate to severe pain.
Secondary outcomes
NRS scores at different time intervals
The severity of pain was measured using the NRS(Numerical Rating Scale), with NRS≥4 indicating moderate to severe pain. The NRS scores for movement, rest, and wound pain at 2 hours, 4 hours, 8 hours, 12 hours, and 24 hours after surgery were observed to determine whether intraperitoneal spray combined with intravenous lidocaine could reduce the incidence of moderate to severe pain in patients undergoing laparoscopic myomectomy.
Sleep quality
The subjective sleep status of Day 0, Day 1 and Day 2 was assessed using the AIS scale. For patients with an AIS score of 4 or higher, the Insomnia Severity Index (ISI) was used to classify the degree of insomnia.
Recovery quality
The Qor-15 scale was used to evaluate the recovery quality of patients in the first two days. QoR-15 Assessment Questionnaire:It includes five dimensions:physical comfort(5 items),physical independence(2 items),emotional state(4 items),psychological support(2 items),and pain(2 items). Scoring details: Each item is scored on an 11-point scale.Higher scores for positive items indicate higher frequency. The total score ranges from 0(worst recovery)to 150(best recovery).
The consumption of analgesic drugs.
The consumption of analgesic drugs was recorded, defined as the cumulative consumption of opioids during surgery and the number and type of rescue medications used after surgery.
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