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Completed

NCT Number: NCT02264795

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Lidocaine

Drug

Lidocaine 2% with epinephrine 5mcg/ml

Other names: Lidocaine HCl

Placebo

Drug

0.9% Sodium Chloride Solution

Other names: Normal saline

Primary outcomes

  1. Pain Score (VAS) 24hr movement

    Time frame: 24 hours

    VAS score (VAS 0-100 mm) for maternal pain on movement at 24 hours postcesarean delivery

Secondary outcomes

  1. Anxiety score before surgery (VAS)

    Time frame: 5 minutes

    Maternal anxiety score before surgery

  2. Pain score (VAS) 2hr rest

    Time frame: 2 hours

    VAS score (VAS 0-100 mm) for maternal pain at rest at 2 hours postcesarean

  3. Pain score (VAS) 2hr movement

    Time frame: 2 hours

    VAS score (VAS 0-100 mm) for maternal pain on movement at 2 hours postcesarean

  4. Pain Score (VAS) 24hr rest

    Time frame: 24 hours

    VAS score (VAS 0-100 mm) for maternal pain at rest at 24 hours postcesarean

  5. Pain Score (VAS) 48hr rest

    Time frame: 48 hours

    VAS score (VAS 0-100 mm) for maternal pain at rest at 48 hours postcesarean

  6. Pain Score (VAS) 48hr movement

    Time frame: 48 hours

    VAS score (VAS 0-100 mm) for maternal pain on movement at 48 hours postcesarean

  7. Patient satisfaction 2hr

    Time frame: 2 hours

    Patient satisfaction at 2 hours postcesarean

  8. Patient satisfaction 24hr

    Time frame: 24 hours

    Patient satisfaction at 24 hours postcesarean

  9. Patient satisfaction 48hr

    Time frame: 48 hours

    Patient satisfaction at 48 hours postcesarean

  10. Opiate consumption PACU

    Time frame: 2 hours

    Opiate consumption on discharge from PACU

  11. Opiate consumption 24hrs

    Time frame: 24 hours

    Opiate consumption within 24 hours postcesarean

  12. Opiate consumption 48hrs

    Time frame: 48 hours

    Opiate consumption within 48 hours postcesarean

  13. Side Effect scores

    Time frame: 48 hours

    Nausea, vomiting and pruritis scores on discharge from PACU, at 24 hours and 48 hours postcesarean

  14. Bowel function

    Time frame: 48 hours

    Return of bowel function as assessed by passing flatus

  15. Time to request for first opiate

    Time frame: 48 hours

    Hours to request for first opiate (if any) postcesarean

Sponsors and collaborators

Lead sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 15, 2014
Registry last updated
May 3, 2016

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.

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