Ropivacaine Continuous Wound Infusion Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery
- Conditions
- Obstetric Pain
- Interventions
- Device: wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain)Procedure: Spinal AnesthesiaDrug: Normal saline
- Registration Number
- NCT03502642
- Lead Sponsor
- Saint-Joseph University
- Brief Summary
Cesarean delivery is one of the most common surgical procedures, performed at an increasingly high rate. It is associated with intense postoperative pain that may hamper the rehabilitation process and interfere with patient satisfaction and care provided to the newborn. Therefore, control of perioperative pain with multimodal regimens using local anesthetic may be important in short- and long-term convalescence after surgery.
Opioid-based regimens are the "gold standard" of cesarean delivery analgesia. However, spinal and epidural opioids have a ceiling effect.
Wound infiltration with local anesthetics has been used widely in the multimodal approach of pain relief. Continuous wound infusion with local anesthetic through a multiorifice catheter increases the duration of action and efficacy of local surgical wound infiltration compared with a one-time wound injection of local anesthetic.
After cesarean delivery, Local anesthetic continuous wound infusion would be associated with better reduction in pain scores when compared to intrathecal morphine . Therefore, an assessor and patient blinded, randomized study that aimed to compare the efficacy and side effects of these analgesia techniques was conducted.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
- women.
- age between 18 and 50 years.
- gestational age 37 to 42 weeks.
- body mass index ranging from 18.0 to 30.0 kg/m2
- American Society of Anesthesiology (ASA) physical status I or II
- elective cesarean delivery with a Pfannenstiel incision
- spinal anesthesia.
- history of chronic opioid use.
- Allergy to opioids and or local anesthetics.
- absolute or relative contraindication to neuraxial anesthesia.
- fever or any other sign of infection.
- Diabetes Mellitus under insulin therapy
- physical separation of patients from the neonate during the postoperative period.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo (P) intrathecal morphine Placebo group parturients will receive spinal anesthesia with intrathecal morphine and will have continuous normal saline wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain). Placebo (P) Normal saline Placebo group parturients will receive spinal anesthesia with intrathecal morphine and will have continuous normal saline wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain). Ropivacaine (R) wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain) Ropivacaine group parturients will receive spinal anesthesia without intrathecal morphine and will have continuous ropivacaine (Ropivacaina Molteni®) wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain). Ropivacaine (R) Ropivacaine (Ropivacaina Molteni®) Ropivacaine group parturients will receive spinal anesthesia without intrathecal morphine and will have continuous ropivacaine (Ropivacaina Molteni®) wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain). Placebo (P) wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain) Placebo group parturients will receive spinal anesthesia with intrathecal morphine and will have continuous normal saline wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain). Ropivacaine (R) Spinal Anesthesia Ropivacaine group parturients will receive spinal anesthesia without intrathecal morphine and will have continuous ropivacaine (Ropivacaina Molteni®) wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain). Placebo (P) Spinal Anesthesia Placebo group parturients will receive spinal anesthesia with intrathecal morphine and will have continuous normal saline wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain).
- Primary Outcome Measures
Name Time Method pain at rest Hour 48 Pain scores at rest were measured postoperatively using visual analog rating scale for pain in which 0 is defined as no pain and 10 as maximum pain.Measures were repeated for 48hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
- Secondary Outcome Measures
Name Time Method pain at mobilization Hour 48 Pain scores at mobilization were measured postoperatively using visual analog rating scale for pain in which 0 is defined as no pain and 10 as maximum pain. Measures were repeated for 48hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
incidence of postoperative nausea and vomiting Hour 48 incidence of postoperative nausea and vomiting. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
incidence of pruritus Hour 48 incidence of pruritus. Measurements were made for 48 hours postoperatively.Hour 0 is the time of arrival to the post anesthesia care unit PACU.
incidence of urinary retention during the 48 hours postoperatively defined as the requirement of bladder recatheterization postoperatively.
return of gastrointestinal function during the 48 hours postoperatively interval from the end of surgery until first gas elimination postoperatively. interval from the end of surgery until first feces elimination postoperatively.
sedation Hour 48 assessed by a 5-point rating scale (0 fully alert,
1 sleepy but easily aroused with verbal stimulation, 2 sleepy but aroused with light touch, 3 sleepy but aroused with pain, and 4 unconscious patient). Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.incidence of neurological alterations Hour 48 patients were specifically asked about paresthesia, tactile hyperesthesia, and headache. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Trial Locations
- Locations (1)
Hotel Dieu de France Hospital
🇱🇧Beirut, Lebanon