Postoperative PainNCT07268495
The Impact of Intraperitoneal Spray Combined With Intravenous Lidocaine on Postoperative Pain After Myomectomy
A study testing Saline, intravenous +saline lidocaine and saline + intraperitoneal lidocaine in people with Postoperative Pain, run by General Hospital of Ningxia Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Saline, intravenous +saline lidocaine and saline + intraperitoneal lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 20 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Surgery duration exceeding 3 hours;
- Need for additional surgery;
- Allergy to the study drugs;
- Presence of severe psychological,hepatic,renal,and cardiac diseases;
- History of chronic pain or arrhythmia.
- Elimination Criteria:
- The patient or their family withdraws from or refuses to participate in the trial during the observation period;
- Conversion from laparoscopy to laparotomy or change in surgical approach during the procedure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
General Hospital of Ningxia Medical University
Yinchuan, Ningxia
Ma Han xiang, 86-13519591508, mahanxiang@hotmail.com
About this study
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.
- Conditions
- Postoperative Pain
- Being tested
- Saline, intravenous +saline lidocaine, saline + intraperitoneal lidocaine, intravenous + intraperitoneal lidocaine
- Keywords
- lidocaine, myomectomy, laparoscopic surgery, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineDrug
Also called placebo
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.
intravenous +saline lidocaineDrug
Also called analgesic
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.
saline + intraperitoneal lidocaineDrug
Also called intraperitoneal spary of 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.
intravenous + intraperitoneal lidocaineDrug
Also called intravenous and intraperitoneal injection of 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.
| Study group | Role | What they receive |
|---|---|---|
| Group C(Control Group) | Active comparator | At the beginning of the operation, intravenous infusion of reifentanil 0.1~0.2μg/kg/min, propofol 2~4mg/kg/h, rocuronium 0.3mg/kg/h intermittently, inhalation of 1%~2% sevoflurane were maintained, the fluctuation of blood pressure was not more than 20% of the basic level, and the heart rate was 50~100 times /min. 10 minutes before the infusion proper amount of normal saline was administered to the patient. Subsequnetly, a continuous intravenous infusion proper amount of normal saline was maintained until the end of the sugery. Before closing the abdominal cavity, 20ml normal saline was administered. Receives: Drug: Saline |
| Group IV(Intravenous injection of lidocaine Group) | Experimental | At the beginning of the operation, intravenous infusion of reifentanil 0.1~0.2μg/kg/min, propofol 2~4mg/kg/h, rocuronium 0.3mg/kg/h intermittently, inhalation of 1%~2% sevoflurane were maintained, the fluctuation of blood pressure was not more than 20% of the basic level, and the heart rate was 50~100 times /min. 10 minutes before the infusion 2% lidocaine (1.5mg/kg) was administered to the patient. Subsequnetly, a continuous intravenous 2% lidocaine (2mg/kg/h) was maintained until the end of the sugery. Before closing the abdominal cavity, 20ml normal saline was administered. Receives: Drug: intravenous +saline lidocaine |
| Group IP(Intraperitoneal spray of lidocaine Group) | Experimental | At the beginning of the operation, intravenous infusion of reifentanil 0.1~0.2μg/kg/min, propofol 2~4mg/kg/h, rocuronium 0.3mg/kg/h intermittently, inhalation of 1%~2% sevoflurane were maintained, the fluctuation of blood pressure was not more than 20% of the basic level, and the heart rate was 50~100 times /min. 10 minutes before the infusion proper amount of normal saline was administered to the patient. Subsequnetly, a continuous intravenous infusion proper amount of normal saline 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. Receives: Drug: saline + intraperitoneal lidocaine |
| Group IVPL(Intravenous and Intraperitoneal spray of lidocaine Group) | Experimental | At the beginning of the operation, intravenous infusion of reifentanil 0.1~0.2μg/kg/min, propofol 2~4mg/kg/h, rocuronium 0.3mg/kg/h intermittently, inhalation of 1%~2% sevoflurane were maintained, the fluctuation of blood pressure was not more than 20% of the basic level, and the heart rate was 50~100 times /min. 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. Receives: Drug: intravenous + intraperitoneal lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 24 hours after surgery
Secondary outcomes (7)
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.
Measured: 2 hours, 4 hours, 8 hours, 12 hours, 24 hours after surgery
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.
Measured: Within 48h hours after surgery
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).
Measured: The first two days after surgery
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.
Measured: Within 24 hours after surgery
The number of lidocaine adverse reactions, postoperative nausea and vomiting, and the use of vasoactive drugs.
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.
Measured: During surgery and within 24 hours after surgery
BIS value
The BIS values of patients before surgery, before skin incision, 30 minutes into the surgery, and at the end of the surgery were recorded.
Measured: During the operation
The time for recovery of bowel function
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.
Measured: After surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start1 Aug 2024
- Primary completion1 Aug 2025
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268495
- Sponsor's protocol ID
- Shaoling Ma-2025-05
- Status last verified
- Nov 2025
- First submitted
- 21 Aug 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Intraperitoneal Spray Combined With Intravenous Lidocaine on Postoperative Pain After Myomectomy
- ClinicalTrials.gov ID
- NCT07268495
- Acronym / sponsor ID
- Shaoling Ma-2025-05
- Conditions
- Postoperative Pain
- Keywords
- lidocaine, myomectomy, laparoscopic surgery, postoperative pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group C(Control Group) | Active comparator | Drug: SalineAt the beginning of the operation, intravenous infusion of reifentanil 0.1~0.2μg/kg/min, propofol 2~4mg/kg/h, rocuronium 0.3mg/kg/h intermittently, inhalation of 1%~2% sevoflurane were maintained, the fluctuation of blood pressure was not more than 20% of the basic level, and the heart rate was 50~100 times /min. 10 minutes before the infusion proper amount of normal saline was administered to the patient. Subsequnetly, a continuous intravenous infusion proper amount of normal saline was maintained until the end of the sugery. Before closing the abdominal cavity, 20ml normal saline was administered. |
| Group IV(Intravenous injection of lidocaine Group) | Experimental | Drug: intravenous +saline lidocaineAt the beginning of the operation, intravenous infusion of reifentanil 0.1~0.2μg/kg/min, propofol 2~4mg/kg/h, rocuronium 0.3mg/kg/h intermittently, inhalation of 1%~2% sevoflurane were maintained, the fluctuation of blood pressure was not more than 20% of the basic level, and the heart rate was 50~100 times /min. 10 minutes before the infusion 2% lidocaine (1.5mg/kg) was administered to the patient. Subsequnetly, a continuous intravenous 2% lidocaine (2mg/kg/h) was maintained until the end of the sugery. Before closing the abdominal cavity, 20ml normal saline was administered. |
| Group IP(Intraperitoneal spray of lidocaine Group) | Experimental | Drug: saline + intraperitoneal lidocaineAt the beginning of the operation, intravenous infusion of reifentanil 0.1~0.2μg/kg/min, propofol 2~4mg/kg/h, rocuronium 0.3mg/kg/h intermittently, inhalation of 1%~2% sevoflurane were maintained, the fluctuation of blood pressure was not more than 20% of the basic level, and the heart rate was 50~100 times /min. 10 minutes before the infusion proper amount of normal saline was administered to the patient. Subsequnetly, a continuous intravenous infusion proper amount of normal saline 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. |
| Group IVPL(Intravenous and Intraperitoneal spray of lidocaine Group) | Experimental | Drug: intravenous + intraperitoneal lidocaineAt the beginning of the operation, intravenous infusion of reifentanil 0.1~0.2μg/kg/min, propofol 2~4mg/kg/h, rocuronium 0.3mg/kg/h intermittently, inhalation of 1%~2% sevoflurane were maintained, the fluctuation of blood pressure was not more than 20% of the basic level, and the heart rate was 50~100 times /min. 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- Surgery duration exceeding 3 hours;
- Need for additional surgery;
- Allergy to the study drugs;
- Presence of severe psychological,hepatic,renal,and cardiac diseases;
- History of chronic pain or arrhythmia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SalineAlso: placebo10 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. | Drug | Group C(Control Group) |
| intravenous +saline lidocaineAlso: analgesic10 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. | Drug | Group IV(Intravenous injection of lidocaine Group) |
| saline + intraperitoneal lidocaineAlso: intraperitoneal spary of lidocaine10 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. | Drug | Group IP(Intraperitoneal spray of lidocaine Group) |
| intravenous + intraperitoneal lidocaineAlso: intravenous and intraperitoneal injection of lidocaine10 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. | Drug | Group IVPL(Intravenous and Intraperitoneal spray of lidocaine Group) |
Primary outcome
The incidence rate of moderate to severe pain within 24 hours
Time frame: 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.
7 secondary outcomes
NRS scores at different time intervals
Time frame: 2 hours, 4 hours, 8 hours, 12 hours, 24 hours after surgery
Sleep quality
Time frame: Within 48h hours after surgery
Recovery quality
Time frame: The first two days after surgery
The consumption of analgesic drugs.
Time frame: Within 24 hours after surgery
The number of lidocaine adverse reactions, postoperative nausea and vomiting, and the use of vasoactive drugs.
Time frame: During surgery and within 24 hours after surgery
BIS value
Time frame: During the operation
The time for recovery of bowel function
Time frame: After surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline, intravenous +saline lidocaine and saline + intraperitoneal lidocaine in people with Postoperative Pain, run by General Hospital of Ningxia Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ma Hanxaing (86-13519591508, mahanxiang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence rate of moderate to severe pain within 24 hours (time frame: Within 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.