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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02264795
• Other study ID #: 14-04
• Status: Completed
• Phase: N/A
• First received: October 9, 2014
• Last updated: May 2, 2016
• Start date: November 2014
• Est. completion date: November 2015

Study information

• Verified date: May 2016
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Lidocaine
Lidocaine 2% with epinephrine 5mcg/ml
• Placebo
0.9% Sodium Chloride Solution

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Score (VAS) 24hr movement	VAS score (VAS 0-100 mm) for maternal pain on movement at 24 hours postcesarean delivery	24 hours	No
Secondary	Anxiety score before surgery (VAS)	Maternal anxiety score before surgery	5 minutes	No
Secondary	Pain score (VAS) 2hr rest	VAS score (VAS 0-100 mm) for maternal pain at rest at 2 hours postcesarean	2 hours	No
Secondary	Pain score (VAS) 2hr movement	VAS score (VAS 0-100 mm) for maternal pain on movement at 2 hours postcesarean	2 hours	No
Secondary	Pain Score (VAS) 24hr rest	VAS score (VAS 0-100 mm) for maternal pain at rest at 24 hours postcesarean	24 hours	No
Secondary	Pain Score (VAS) 48hr rest	VAS score (VAS 0-100 mm) for maternal pain at rest at 48 hours postcesarean	48 hours	No
Secondary	Pain Score (VAS) 48hr movement	VAS score (VAS 0-100 mm) for maternal pain on movement at 48 hours postcesarean	48 hours	No
Secondary	Patient satisfaction 2hr	Patient satisfaction at 2 hours postcesarean	2 hours	No
Secondary	Patient satisfaction 24hr	Patient satisfaction at 24 hours postcesarean	24 hours	No
Secondary	Patient satisfaction 48hr	Patient satisfaction at 48 hours postcesarean	48 hours	No
Secondary	Opiate consumption PACU	Opiate consumption on discharge from PACU	2 hours	No
Secondary	Opiate consumption 24hrs	Opiate consumption within 24 hours postcesarean	24 hours	No
Secondary	Opiate consumption 48hrs	Opiate consumption within 48 hours postcesarean	48 hours	No
Secondary	Side Effect scores	Nausea, vomiting and pruritis scores on discharge from PACU, at 24 hours and 48 hours postcesarean	48 hours	No
Secondary	Bowel function	Return of bowel function as assessed by passing flatus	48 hours	No
Secondary	Time to request for first opiate	Hours to request for first opiate (if any) postcesarean	48 hours	No