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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 |
| --- | --- | --- |
| 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 | 
| Bowel function | Return of bowel function as assessed by passing flatus | 48 hours | 
| Time to request for first opiate | Hours to request for first opiate (if any) postcesarean | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cesarean section, Lidocaine