Does Intraperitoneal Instillation of Lidocaine at Cesarean Delivery Improve Postoperative Analgesia?

Does Intraperitoneal Instillation of Lidocaine at Cesarean Delivery Improve Postoperative Analgesia? A Randomized, Double-blind, Placebo-controlled Trial

The instillation of local anesthetic into the peritoneum has been found to be safe and effective in reducing postoperative pain and morphine consumption after abdominal surgery. A review of studies reporting serum levels of local anesthetic after intraperitoneal delivery found no cases of clinical toxicity in any of the trials. The studies in this meta-analysis did not include post-cesarean delivery pain and there is a lack of data to support the use of intraperitoneal local anesthetic after cesarean section.

The purpose of this study is to assess the efficacy of intraperitoneal lidocaine on postoperative pain scores after cesarean delivery. This study will compare a 20ml solution of lidocaine (400mg) with epinephrine 5mcg/ml versus normal saline (placebo) instilled into the peritoneum at the end of surgery in women undergoing cesarean delivery. The investigators hypothesize that intraperitoneal lidocaine will result in lower pain scores, reduce opioid consumption and opioid related side effects, and higher maternal satisfaction after cesarean delivery.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Placebo; Drug: Lidocaine

Detailed Description

Postoperative pain after cesarean delivery can have a significant negative impact on the mother's ability to care for her newborn and lead to complications such as thromboembolism, chronic pain, and depression. Postoperative analgesia for cesarean delivery has undergone remarkable improvement and is currently based on a multimodal approach to improve pain control and reduce the systemic complications of opiates. Despite this some patients still experience moderate to severe pain after cesarean delivery, and further strategies to improve analgesia and postoperative recovery are warranted.

The use of intraperitoneal local anesthetics to reduce postoperative pain has been studied in a variety of surgical settings, such as hysterectomy, laparoscopic cholecystectomy and minor laparoscopic gynecological procedures. These studies have compared different local anesthetics and the timing of local anesthetic delivery in relation to surgery, for example pre-procedure, at the end of surgery or via continuous catheter infusion. Intraperitoneal lidocaine at the end of surgery was associated with lower postoperative pain scores after total abdominal hysterectomy (200mg lidocaine) and laparoscopic cholecystectomy (400mg lidocaine). There is a large growing body of evidence to support the use of intraperitoneal local anesthetic to reduce postoperative pain. However, there is a lack of data to support its use in postcesarean delivery pain. The investigators found one study reporting a decreased incidence of postoperative pain following intraperitoneal lidocaine instillation at the end of cesarean delivery, in which the parietal peritoneum had been sutured.

The purpose of this study is to evaluate the efficacy of intraperitoneal lidocaine 400mg instillation at the end of cesarean delivery on maternal pain scores and satisfaction, in the context of a multimodal analgesic regimen inclusive of intrathecal opioids and systemic NSAIDs, acetaminophen and opioids. The investigators hypothesize that intraperitoneal lidocaine will decrease VAS pain scores, reduce opioid consumption and opioid related side effects, and increase maternal satisfaction after cesarean delivery.

• Study Type: Interventional
• Enrollment (Actual): 204
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G1X5
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• ASA I or II patients
• 18-50 years of age
• Term pregnancy
• Singleton pregnancy
• Spinal anesthetic
• Pfannenstiel incision
• Patients who have given pre-operative informed written consent

Exclusion Criteria:

• Patients who refuse or are unable to give consent
• ASA >2
• Multiple gestation
• Chronic pain
• BMI >40
• Contraindication to acetaminophen or non-steroidal anti-inflammatory drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Intraperitoneal instillation of normal saline.	Drug: Placebo; 0.9% Sodium Chloride Solution; Other Names: Normal saline
Active Comparator: Lidocaine; Intraperitoneal instillation lidocaine 2% (400mg) with epinephrine 5mcg/ml.	Drug: Lidocaine; Lidocaine 2% with epinephrine 5mcg/ml; Other Names: Lidocaine HCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score (VAS) 24hr movement	VAS score (VAS 0-100 mm) for maternal pain on movement at 24 hours postcesarean delivery	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bowel function	Return of bowel function as assessed by passing flatus	48 hours
Anxiety score before surgery (VAS)	Maternal anxiety score before surgery	5 minutes
Pain score (VAS) 2hr rest	VAS score (VAS 0-100 mm) for maternal pain at rest at 2 hours postcesarean	2 hours
Pain score (VAS) 2hr movement	VAS score (VAS 0-100 mm) for maternal pain on movement at 2 hours postcesarean	2 hours
Pain Score (VAS) 24hr rest	VAS score (VAS 0-100 mm) for maternal pain at rest at 24 hours postcesarean	24 hours
Pain Score (VAS) 48hr rest	VAS score (VAS 0-100 mm) for maternal pain at rest at 48 hours postcesarean	48 hours
Pain Score (VAS) 48hr movement	VAS score (VAS 0-100 mm) for maternal pain on movement at 48 hours postcesarean	48 hours
Patient satisfaction 2hr	Patient satisfaction at 2 hours postcesarean	2 hours
Patient satisfaction 24hr	Patient satisfaction at 24 hours postcesarean	24 hours
Patient satisfaction 48hr	Patient satisfaction at 48 hours postcesarean	48 hours
Opiate consumption PACU	Opiate consumption on discharge from PACU	2 hours
Opiate consumption 24hrs	Opiate consumption within 24 hours postcesarean	24 hours
Opiate consumption 48hrs	Opiate consumption within 48 hours postcesarean	48 hours
Side Effect scores	Nausea, vomiting and pruritis scores on discharge from PACU, at 24 hours and 48 hours postcesarean	48 hours
Time to request for first opiate	Hours to request for first opiate (if any) postcesarean	48 hours

Collaborators and Investigators

• Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Investigators: Principal Investigator: Naveed Siddiqui, MD, Mount Sinai Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: October 9, 2014
• First Submitted That Met QC Criteria: October 14, 2014
• First Posted (Estimate): October 15, 2014

Study Record Updates

• Last Update Posted (Estimate): May 3, 2016
• Last Update Submitted That Met QC Criteria: May 2, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Cesarean section; Lidocaine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 14-04