Does Intraperitoneal Instillation of Lidocaine at Cesarean Delivery Improve Postoperative Analgesia?
Information source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Lidocaine (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Samuel Lunenfeld Research Institute, Mount Sinai Hospital Official(s) and/or principal investigator(s):
Naveed Siddiqui, MD, Principal Investigator, Affiliation: Mount Sinai Hospital, New York
Overall contact:
Naveed Siddiqui, MD, Phone: 416-586-4800, Ext: 5270, Email: naveed.siddiqui@uhn.ca
Summary
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.
Clinical Details
Official title: Does Intraperitoneal Instillation of Lidocaine at Cesarean Delivery Improve Postoperative Analgesia? A Randomized, Double-blind, Placebo-controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Pain Score (VAS) 24hr movement
Secondary outcome: Anxiety score before surgery (VAS)Pain score (VAS) 2hr rest Pain score (VAS) 2hr movement Pain Score (VAS) 24hr rest Pain Score (VAS) 48hr rest Pain Score (VAS) 48hr movement Patient satisfaction 2hr Patient satisfaction 24hr Patient satisfaction 48hr Opiate consumption PACU Opiate consumption 24hrs Opiate consumption 48hrs Side Effect scores Bowel function Time to request for first opiate
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Naveed Siddiqui, MD, Phone: 416-586-4800, Ext: 5270, Email: naveed.siddiqui@uhn.ca
Mount Sinai Hospital, Toronto, Ontario M5G1X5, Canada; Recruiting
Naveed Siddiqui, MD, Phone: 416-586-4800, Ext: 5270, Email: naveed.siddiqui@uhn.ca
Ruchira Patel, MD, Sub-Investigator
Jose Carvalho, MD, Sub-Investigator
Paul Bernstein, MD, Sub-Investigator
Kristi Downey, MSc, Sub-Investigator
Additional Information
Starting date: November 2014
Last updated: May 22, 2015
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