Skip to main content
OpenTrials
Completed

NCT Number: NCT06433713

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Cairo University Kasr Al Aini School of Medicine

Cairo, 11562, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years.
  • American society of anesthesiology (ASA) class II (Normal pregnancy, well controlled gestational HTN, controlled preeclampsia without severe features, diet-controlled gestational DM).
  • Singleton term pregnancy.
  • Elective caesarean section.
  • Spinal anesthesia.

Exclusion criteria

  • Atypical postoperative care e.g. following caesarean hysterectomy.
  • Inflammatory bowel disease.
  • Prolonged surgery >1.5 hours.
  • Medical disorders e.g. liver or renal affection
  • Previous bowel surgery.
  • History' of allergic reaction to lidocaine.

Treatment and study plan

Lidocaine IV

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.

Placebo

Drug

0.9% normal saline infusion

Other names: Normal saline

Primary outcomes

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

    Time frame: 12-24 hours

    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

  2. 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

    Time to hearing of bowel sounds, passing of flatus & passing of stool

Secondary outcomes

  1. Occurrence of lidocaine toxicity with the standard dose given.

    Time frame: 12-24 hours

    Nausea, perioral numbness, neurological symptoms or cardiac arrhythmia

  2. Duration of hospital stay.

    Time frame: 12-24 hours

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 30, 2024
Registry last updated
May 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.