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

NCT ID: NCT06433713

Last Updated: 2024-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-04-01

Brief 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.

Conditions

Postoperative Pain; Postoperative Return of Bowel Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Lidocaine Group

Intravenous lidocaine infusion, 2 mg/kg/hour

Group Type: EXPERIMENTAL

Lidocaine IV

Intervention Type: DRUG

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.

Control Group

Normal saline infusion

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

0.9% normal saline infusion

Interventions

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.

Intervention Type: DRUG

Placebo

0.9% normal saline infusion

Intervention Type: DRUG

Other Intervention Names

Normal saline

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Amr Fathy Zaky

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University Kasr Al Aini School of Medicine

Cairo, , Egypt

Countries

Egypt

Other Identifiers

MS-220

Identifier Type: -

Identifier Source: org_study_id