Mount Sinai Hospital
Toronto, Ontario, M5G1X5, Canada
NCT Number: NCT02264795
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.
Looking for future studies?
Notify Me18 year–50 year
Female
Interventional
Not applicable
Toronto, Ontario, M5G1X5, Canada
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Lidocaine 2% with epinephrine 5mcg/ml
Other names: Lidocaine HCl
0.9% Sodium Chloride Solution
Other names: Normal saline
Time frame: 24 hours
VAS score (VAS 0-100 mm) for maternal pain on movement at 24 hours postcesarean delivery
Time frame: 5 minutes
Maternal anxiety score before surgery
Time frame: 2 hours
VAS score (VAS 0-100 mm) for maternal pain at rest at 2 hours postcesarean
Time frame: 2 hours
VAS score (VAS 0-100 mm) for maternal pain on movement at 2 hours postcesarean
Time frame: 24 hours
VAS score (VAS 0-100 mm) for maternal pain at rest at 24 hours postcesarean
Time frame: 48 hours
VAS score (VAS 0-100 mm) for maternal pain at rest at 48 hours postcesarean
Time frame: 48 hours
VAS score (VAS 0-100 mm) for maternal pain on movement at 48 hours postcesarean
Time frame: 2 hours
Patient satisfaction at 2 hours postcesarean
Time frame: 24 hours
Patient satisfaction at 24 hours postcesarean
Time frame: 48 hours
Patient satisfaction at 48 hours postcesarean
Time frame: 2 hours
Opiate consumption on discharge from PACU
Time frame: 24 hours
Opiate consumption within 24 hours postcesarean
Time frame: 48 hours
Opiate consumption within 48 hours postcesarean
Time frame: 48 hours
Nausea, vomiting and pruritis scores on discharge from PACU, at 24 hours and 48 hours postcesarean
Time frame: 48 hours
Return of bowel function as assessed by passing flatus
Time frame: 48 hours
Hours to request for first opiate (if any) postcesarean
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Other
Does Intraperitoneal Instillation of Lidocaine at Cesarean Delivery Improve Postoperative Analgesia? A Randomized, Double-blind, Placebo-controlled Trial
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.
NCT07025161
Neurologic Manifestations, Pain
Orlando, Florida, United States
View Trial DetailsNCT05283980
Acute Pain, Behavior
Boston, Massachusetts, United States
View Trial DetailsNCT06869369
Behavior, Motor Activity
Kütahya, Turkey (Türkiye)
View Trial DetailsNCT07729020
Anxiety, Anxiety Disorders
Genoa, Liguria, Italy
View Trial Details