The Impact of Intraperitoneal Spray Combined With Intravenous Lidocaine on Postoperative Pain After Myomectomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorGeneral Hospital of Ningxia Medical University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Saline

    Drug

    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 lidocaine

    Drug

    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 lidocaine

    Drug

    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 lidocaine

    Drug

    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.

Treatment groups

100 Participants
are divided into 4 treatment groups
Group A: Group C(Control Group)Active comparator 1 intervention
Group B: Group IV(Intravenous injection of lidocaine Group)Experimental treatment 1 intervention
Group C: Group IP(Intraperitoneal spray of lidocaine Group)Experimental treatment 1 intervention
Group D: Group IVPL(Intravenous and Intraperitoneal spray of lidocaine Group)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Within 24 hours after surgery

Secondary outcomes

1

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.

Time frame
2 hours, 4 hours, 8 hours, 12 hours, 24 hours after surgery
2

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.

Time frame
Within 48h hours after surgery
3

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).

Time frame
The first two days after surgery
4

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.

Time frame
Within 24 hours after surgery

Other outcomes

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