Postoperative Pain
Conditions
Keywords
lidocaine, myomectomy, laparoscopic surgery, postoperative pain
Brief summary
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.
Interventions
DRUGSaline
10 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.
DRUGintravenous +saline lidocaine
10 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.
DRUGsaline + intraperitoneal lidocaine
10 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.
DRUGintravenous + intraperitoneal lidocaine
10 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.
Sponsors
General Hospital of Ningxia Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age:18-65 years old; 2. ASA physical status classification I - III; 3. Undergoing laparoscopic hysteromyoma resection under general anesthesia; 4. The patient has been informed and has signed the informed consent form.
Exclusion criteria
1. Surgery duration exceeding 3 hours; 2. Need for additional surgery; 3. Allergy to the study drugs; 4. Presence of severe psychological,hepatic,renal,and cardiac diseases; 5. History of chronic pain or arrhythmia. Elimination Criteria: 1. The patient or their family withdraws from or refuses to participate in the trial during the observation period; 2. Conversion from laparoscopy to laparotomy or change in surgical approach during the procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence rate of moderate to severe pain within 24 hours | Within 24 hours after surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| NRS scores at different time intervals | 2 hours, 4 hours, 8 hours, 12 hours, 24 hours after surgery | 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 | Within 48h hours after surgery | 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 first two days after surgery | 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. | Within 24 hours after surgery | 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. |
| The number of lidocaine adverse reactions, postoperative nausea and vomiting, and the use of vasoactive drugs. | During surgery and within 24 hours after surgery | The number of adverse reactions to lidocaine in patients during and within 24 hours after surgery was recorded, including tinnitus, perioral numbness, nystagmus, impaired consciousness, muscle twitching, convulsions, coma, bradycardia, arrhythmia, conduction block, hypotension, and circulatory collapse. The number and dosage of vasoactive drugs used by patients during surgery were recorded. The number of postoperative nausea and vomiting occurrences was recorded, defined as the recording of any nausea or vomiting within 24 hours after surgery. |
| BIS value | During the operation | The BIS values of patients before surgery, before skin incision, 30 minutes into the surgery, and at the end of the surgery were recorded. |
| The time for recovery of bowel function | After surgery | Record the recovery time of gastrointestinal function,which is defined as the time of the patient's first flatus,first defecation,and removal of the urinary catheter immediately after the surgery. |
Countries
China
Contacts
Primary ContactMa Hanxaing
Outcome results
None listed