## Protocol Section
### Identification Module
**NCT ID:** NCT06433713

**Brief Title:** Effect of Intraoperative Intravenous Lidocaine on Postoperative Pain and Return of Bowel Function After Cesarean Sections

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

#### Organization Study ID Info
**ID:** MS-220
#### Organization
**Class:** OTHER
**Full Name:** Cairo University
### Status Module
#### Completion Date
**Date:** 2024-04-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-27

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-03-01

**Type:** ACTUAL

#### Start Date
**Date:** 2023-12-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-24
**Study First Submit QC Date:** 2024-05-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Cairo University

#### Responsible Party

**Investigator Affiliation:** Cairo University

**Investigator Full Name:** Amr Fathy Zaky

**Investigator Title:** Lecturer

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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 Module

**Conditions:**

- Postoperative Pain

- Postoperative Return of Bowel Function

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 60

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Intravenous lidocaine infusion, 2 mg/kg/hour

**Intervention Names:**

- Drug: Lidocaine IV

**Label:** Lidocaine Group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Normal saline infusion

**Intervention Names:**

- Drug: Placebo

**Label:** Control Group

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Lidocaine Group

**Description:** 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.

**Name:** Lidocaine IV

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Control Group

**Description:** 0.9% normal saline infusion

**Name:** Placebo

**Other Names:**

- Normal saline

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** Effect of intraoperative intravenous lidocaine on visual analogue scale pain scores among the two groups.

**Time Frame:** 12-24 hours

**Description:** Time to hearing of bowel sounds, passing of flatus \& passing of stool

**Measure:** 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 Frame:** 12-24 hours

#### Secondary Outcomes

**Description:** Nausea, perioral numbness, neurological symptoms or cardiac arrhythmia

**Measure:** Occurrence of lidocaine toxicity with the standard dose given.

**Time Frame:** 12-24 hours

**Measure:** Duration of hospital stay.

**Time Frame:** 12-24 hours

### Eligibility Module

**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.

**Healthy Volunteers:** True

**Maximum Age:** 45 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Cairo

**Country:** Egypt

**Facility:** Cairo University Kasr Al Aini School of Medicine

**Zip:** 11562

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011183

- Term: Postoperative Complications

- ID: D000010335

- Term: Pathologic Processes

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M13069

- Name: Pain, Postoperative

- Relevance: HIGH

- As Found: Postoperative Pain

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010149

- Term: Pain, Postoperative

### Intervention Browse Module - Ancestors

- ID: D000000779

- Term: Anesthetics, Local

- ID: D000000777

- Term: Anesthetics

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000000889

- Term: Anti-Arrhythmia Agents

- ID: D000061567

- Term: Voltage-Gated Sodium Channel Blockers

- ID: D000026941

- Term: Sodium Channel Blockers

- ID: D000049990

- Term: Membrane Transport Modulators

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: AnArAg

- Name: Anti-Arrhythmia Agents

- Abbrev: ChanBlk

- Name: Channel Blockers

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M11014

- Name: Lidocaine

- Relevance: HIGH

- As Found: Solution

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M4109

- Name: Anesthetics, Local

- Relevance: LOW

- As Found: Unknown

- ID: M4213

- Name: Anti-Arrhythmia Agents

- Relevance: LOW

- As Found: Unknown

- ID: M23177

- Name: Sodium Channel Blockers

- Relevance: LOW

- As Found: Unknown

- ID: M30025

- Name: Diuretics, Potassium Sparing

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000008012

- Term: Lidocaine

### Misc Info Module

- Version Holder: 2024-05-31
