Dexmedetomidine Reduce Postoperative Pain of C-section

Intraperitoneal Installation of Can Enhance Postoperative Analgesia of Caesarean Section

The purpose of this study was to make sure whether the infiltration of dexmedetomidine around the uterus can reduce the pain of cesarean section surgery.Studies have shown that the use of local anesthetic infiltration around the uterus can reduce pain after cesarean section surgery.In observed group, 50ug of dexmedetomidine (volume 10ml) was infiltrated around the uterus at the end of the caesarean section, while in controled group, 10ml normal saline as placebo was infiltrated around the uterus. VASs was accessed in 2h 12h,24h,48h after surgery.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Placebo; Drug: Dexmedetomidine

Detailed Description

Cesarean section is one of the most common inpatient surgical procedures in the world, and in China, with the implementation of the comprehensive two-child policy, the number of elderly mothers and patients undergoing another cesarean section has gradually increased, and the cesarean section rate has also gradually increased; however, despite the many measures taken to control post-cesarean pain, there are still many people with inadequate pain control. Pain after cesarean delivery can have a significant negative impact on both the physical and psychological aspects of the mother and lead to complications such as thromboembolism, chronic pain and depression. Currently, a variety of methods are available to relieve post-cesarean pain, such as patient controlled intravenous analgesia (PCIA), patient controlled epidural analgesia (PCEA), transversus abdominis plane block (TAPB), etc. However, these analgesic methods are not perfect, and each has its own shortcomings. The currently prevalent ERAS concept focuses on multimodal analgesia and minimizing the use of opioids to reduce perioperative stress and reduce opioid nociceptive allergy. Compared to the technical difficulties, risks and other potential complications, abdominal medication has some advantages.

Intraperitoneal spray of local anesthetic (IPLA) has become a commonly used method of analgesia after laparotomy. Intraperitoneal administration is simple, safe, and can relieve postoperative pain, shorten the length of hospital stay, and improve comfort.

One study showed that the use of intraperitoneal infusion of lidocaine (400 mg) improved pain management in the early postoperative period after cesarean section and reduced the number of patients requiring systemic opioids in the immediate postpartum period. It has also been demonstrated that in patients undergoing bariatric surgery, intraoperative intraperitoneal spraying of ropivacaine resulted in effective postoperative pain relief, less need for morphine postoperatively, earlier activity and feeding, and shorter hospital stays, that effective pain control encouraged early bedtime, reduced the risk of thrombosis, and reduced pulmonary complications such as atelectasis or pneumonia, and that 24-hour postoperative blood counts showed significantly lower leukocyte counts were significantly lower.

Dexmedetomidine is a potent, multifunctional, highly selective α2-adrenergic agonist. It has been shown in the literature that the application of dexmedetomidine can effectively reduce the perioperative stress response, significantly reduce the dosage of opioids in the perioperative period and prevent the transformation of acute postoperative pain into chronic pain. Some animal experiments have shown that dexmedetomidine alone has obvious analgesic effect when sprayed intraperitoneally with 12.5μg/kg of dexmedetomidine, the peak time is 20-30 minutes after administration, and the duration of action is 90 minutes. There are few studies on the use of dexmedetomidine alone intraperitoneally to reduce postoperative pain in the clinical setting and there is a lack of data to support its use in post-caesarean pain.

The purpose of this study was to assess the effect of intraperitoneal dexmedetomidine 50μg at the end of cesarean delivery on maternal pain scores and satisfaction in the context of a multimodal analgesic protocol.

The investigators hypothesized that intraperitoneal dexmedetomidine would reduce VAS pain scores, reduce the number of patient-administered intravenous analgesic pump uses and opioid-related side effects, and increase maternal satisfaction after cesarean delivery.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Zhiming Zhang, Ph.D; Phone Number: 13875555649; Email: otc0735@163.com
• Study Contact Backup: Name: Yuan Qin, MD; Phone Number: 13657381087; Email: uscqinyuan@163.com

Study Locations

• China
  • Hunan
    • Chenzhou, Hunan, China, 423000
      • Recruiting
      • Zhiming Zhang
      • Contact: Zhang Zhiming, M.D.; Phone Number: +8613875555649; Email: otc0735@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• ASA Ⅰ or Ⅱ patients
• 18-50 years of age
• BMI<40
• Term pregnancy
• Singleton pregnancy
• Spinal anesthetic
• Patients who have given pre-operative informed written consent

Exclusion Criteria:

• Patients who refuse or are unable to give consent
• ASA>Ⅱ
• Multiple gestation
• Chronic pain
• allergic to any medication in the study protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Intraperitoneal instillation of normal saline	Drug: Placebo; 0.9% Sodium Chloride Solution; Other Names: Normal saline
Active Comparator: Dexmedetomidines; Intraperitoneal instillation Dexmedetomidine 5ug/ml (10ml,50ug)	Drug: Dexmedetomidine; Dexmedetomidine 0.0005%; Other Names: Dexmedetomidine Hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score (VAS) 48hr rest	VAS score (VAS 0-10 cm) for maternal pain on rest at 48 hours postcesarean delivery	48 hours
Pain Score (VAS) 48hr movement	VAS score (VAS 0-10 cm) for maternal pain on movement at 48 hours postcesarean delivery	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score (VAS) 2hr rest	VAS score (VAS 0-10 cm) for maternal pain on rest at 2 hours postcesarean delivery	2 hours
Pain Score (VAS) 2hr movement	VAS score (VAS 0-10 cm) for maternal pain on movement at 2 hours postcesarean delivery	2 hours
Pain Score (VAS) 24hr rest	VAS score (VAS 0-10 cm) for maternal pain on rest at 24 hours postcesarean delivery	24 hours
Pain Score (VAS) 24hr movement	VAS score (VAS 0-10 cm) for maternal pain on movement at 24 hours postcesarean delivery	24 hours
Effective presses of PCIA pump 48hrs	Number of effective presses of PCIA pump at 48 hours postcesarean delivery	48 hours
Patient satisfaction 48hrs	Patient satisfaction at 48 hours postcesarean	48 hours
Bowel function	Return of bowel function as assessed by passing flatus	48 hours
Side Effect scores	Nausea, vomiting and pruritis score at 24 hours and 48 hours postcesarean delivery	48 hours
Flurbiprofen Axetil consumption 48hrs	Flurbiprofen Axetil consumption within 48 hours postcesarean delivery	48 hours

Collaborators and Investigators

• Sponsor: First People's Hospital of Chenzhou

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): March 31, 2023
• Study Completion (Anticipated): March 31, 2023

Study Registration Dates

• First Submitted: November 12, 2022
• First Submitted That Met QC Criteria: November 12, 2022
• First Posted (Actual): November 18, 2022

Study Record Updates

• Last Update Posted (Actual): November 18, 2022
• Last Update Submitted That Met QC Criteria: November 12, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Cesarean section; Dexmedetomidine; Postoperative analgesia; Intraperitoneal spraying
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 202002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No