Effect of Intraoperative Intravenous Lidocaine on Postoperative Pain and Return of Bowel Function After Cesarean Sections

Postoperative Pain Clinical Trial

Official title:

Effect of Intraoperative Intravenous Lidocaine on Postoperative Pain and Return of Bowel Function After Cesarean Sections, a Double-blinded Randomized Control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06433713
• Other study ID #: MS-220
• Status: Completed
• Phase: Phase 2
• Start date: December 1, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: May 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Postoperative discomfort is a frequently seen adverse event after to caesarean operation. Early mobilization and bonding of the mother and her infant are typically impacted by this phenomenon. Nevertheless, the current state of postoperative analgesia and recovery remains inadequate in clinical settings. In the context of major abdominal surgery, opioids are often regarded as the preferred postoperative analgesic. Nevertheless, they possess adverse side effects that might impact the process of recuperation after surgery. These symptoms include nausea and vomiting, decreased bowel movement, and shallow breathing. One additional challenging consequence after surgery is the delayed restoration of bowel function, which has the potential to extend the duration of hospitalization and impede the initiation of oral feeding, resulting in gaseous colonic distension. The administration of lidocaine infusion has been shown to possess analgesic, anti-hyperalgesic, and anti-inflammatory characteristics. The use of intravenous lidocaine after surgery is postulated to have the dual effect of mitigating postoperative pain and expediting the resumption of bowel movements. Recent studies have shown that the administration of intravenous lidocaine, either as a single dosage or by continuous infusion, may have potential advantages in maintaining gastrointestinal motility and exerting an impact on biochemical pain mechanisms. However, the literature presents contradictory data about the effectiveness of lidocaine in providing sufficient postoperative pain relief and reducing postoperative ileus. Consequently, this study was conducted and aimed to assess the effect of intravenous intraoperative lidocaine on postoperative pain and early return of bowel function following elective caesarean section. This randomized clinical trial was conducted at Obstetrics and Gynecology Department, Faculty of Medicine, Cairo University Hospitals from August till December 2023. A total of 60 pregnant women underwent elective caesarean section were enrolled and randomized into two groups; experimental group who received IV infusion of lidocaine starting with skin incision, which was maintained until skin closure and control group who received 0.9% normal saline at the same rate as that described in the experimental group. Both groups were compared as regard total operative time, medications given, start-stop time of the study drug infusion, and degree of pain using visual analogue scale, need for analgesics, time for first healing of normal intestinal sounds and time to first flatus and symptoms of lidocaine toxicity were recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Age > 18 years.

2. American society of anesthesiology (ASA) class II (Normal pregnancy, well controlled gestational HTN, controlled preeclampsia without severe features, diet-controlled gestational DM).

3. Singleton term pregnancy.

4. Elective caesarean section.

5. Spinal anesthesia.

Exclusion Criteria:

1. Atypical postoperative care e.g. following caesarean hysterectomy.

2. Inflammatory bowel disease.

3. Prolonged surgery >1.5 hours.

4. Medical disorders e.g. liver or renal affection

5. Previous bowel surgery.

6. History' of allergic reaction to lidocaine.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Lidocaine IV
They received IV infusion of 2 mg/kg per hour of lidocaine starting with skin incision, which was maintained until skin closure. This was done using a syringe pump with the calculated amount of lidocaine added to 50 ml of normal saline infused at a rate of 50 ml/hr.
• Placebo
0.9% normal saline infusion

Locations

Country	Name	City	State
Egypt	Cairo University Kasr Al Aini School of Medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of intraoperative intravenous lidocaine on visual analogue scale pain scores among the two groups.	The patients are asked to describe how much pain they feel in a scale from 0 to 10. Minimum score 0, maximum score 10 where 10 is worse and means more pain	12-24 hours
Primary	Effect of intraoperative intravenous lidocaine on early return of bowel function assessed by the time to first hearing of bowel sounds and the time to first flatus passing.	Time to hearing of bowel sounds, passing of flatus & passing of stool	12-24 hours
Secondary	Occurrence of lidocaine toxicity with the standard dose given.	Nausea, perioral numbness, neurological symptoms or cardiac arrhythmia	12-24 hours
Secondary	Duration of hospital stay.		12-24 hours