Ropivacaine Continuous Wound Infusion Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery

Study Overview
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Brief Summary
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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.

Official Title
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Ropivacaine Continuous Wound Infusion Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery : A Randomized Controlled Trial

Conditions
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Obstetric Pain

Intervention / Treatment
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* Device: wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain)
* Procedure: Spinal Anesthesia
* Drug: intrathecal morphine
* Drug: Ropivacaine (Ropivacaina Molteni®)
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo (P)<br>Placebo group parturients will receive spinal anesthesia with intrathecal morphine and will have continuous normal saline wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain). | Device: wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain)<br>* After peritoneum closure a 16cm multiorifice perforated catheter (Dosi-Pain® Kit, LEVENTON SAU, Spain) was inserted by the surgeon below the fascia used for normal saline continuous infusion in the Placebo group and for continuous ropivacaine infusion (Ropivacaina Molteni®, MOLTENI FARMACEUTICI, Italy) in the ropivacaine group.<br>* Other names: wound catheter;Procedure: Spinal Anesthesia<br>* Cesarean section was conducted under spinal anesthesia in both groups<br>Drug: intrathecal morphine<br>* Intrathecal morphine was administered during spinal anesthesia in the placebo group but not in the ropivacaine group<br>Drug: Normal saline<br>* A10ml bolus of normal saline were administered in the wound catheter after skin closure then an infusion of normal saline at the rate of 5ml/h was administered as wound infusion via the Dosi-Pain® Kit for 48hours.<br>* Other names: Placebo;|
| Active Comparator: Ropivacaine (R)<br>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). | Device: wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain)<br>* After peritoneum closure a 16cm multiorifice perforated catheter (Dosi-Pain® Kit, LEVENTON SAU, Spain) was inserted by the surgeon below the fascia used for normal saline continuous infusion in the Placebo group and for continuous ropivacaine infusion (Ropivacaina Molteni®, MOLTENI FARMACEUTICI, Italy) in the ropivacaine group.<br>* Other names: wound catheter;Procedure: Spinal Anesthesia<br>* Cesarean section was conducted under spinal anesthesia in both groups<br>Drug: Ropivacaine (Ropivacaina Molteni®)<br>* A10ml bolus of ropivacaine 7.5mg/ml were administered in the wound catheter after skin closure then an infusion of ropivacaine 2mg/ml at the rate of 5ml/h was administered as wound infusion via the Dosi-Pain® Kit for 48hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain at rest | 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. | Hour 0, Hour 2, Hour 6, Hour 12, Hour 24, Hour 36 and Hour 48 | 
| pain at rest | 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. | Hour 2 | 
| pain at rest | 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. | Hour 6 | 
| pain at rest | 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. | Hour 12 | 
| pain at rest | 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. | Hour 24 | 
| pain at rest | 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. | Hour 36 | 
| pain at rest | 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. | Hour 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain at mobilization | 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. | Hour 0 | 
| pain at mobilization | 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. | Hour 2 | 
| pain at mobilization | 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. | Hour 6 | 
| pain at mobilization | 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. | Hour 12 | 
| pain at mobilization | 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. | Hour 24 | 
| pain at mobilization | 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. | Hour 36 | 
| pain at mobilization | 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. | Hour 48 | 
| incidence of postoperative nausea and vomiting | 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. | Hour 0 | 
| incidence of postoperative nausea and vomiting | 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. | Hour 2 | 
| incidence of postoperative nausea and vomiting | 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. | Hour 6 | 
| incidence of postoperative nausea and vomiting | 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. | Hour 12 | 
| incidence of postoperative nausea and vomiting | 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. | Hour 24 | 
| incidence of postoperative nausea and vomiting | 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. | Hour 36 | 
| incidence of postoperative nausea and vomiting | 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. | Hour 48 | 
| incidence of pruritus | incidence of pruritus. Measurements were made for 48 hours postoperatively.Hour 0 is the time of arrival to the post anesthesia care unit PACU. | Hour 0 | 
| incidence of pruritus | incidence of pruritus. Measurements were made for 48 hours postoperatively.Hour 0 is the time of arrival to the post anesthesia care unit PACU. | Hour 2 | 
| incidence of pruritus | incidence of pruritus. Measurements were made for 48 hours postoperatively.Hour 0 is the time of arrival to the post anesthesia care unit PACU. | Hour 6 | 
| incidence of pruritus | incidence of pruritus. Measurements were made for 48 hours postoperatively.Hour 0 is the time of arrival to the post anesthesia care unit PACU. | Hour 12 | 
| incidence of pruritus | incidence of pruritus. Measurements were made for 48 hours postoperatively.Hour 0 is the time of arrival to the post anesthesia care unit PACU. | Hour 24 | 
| incidence of pruritus | incidence of pruritus. Measurements were made for 48 hours postoperatively.Hour 0 is the time of arrival to the post anesthesia care unit PACU. | Hour 36 | 
| incidence of pruritus | incidence of pruritus. Measurements were made for 48 hours postoperatively.Hour 0 is the time of arrival to the post anesthesia care unit PACU. | Hour 48 | 
| incidence of urinary retention | defined as the requirement of bladder recatheterization postoperatively. | during the 48 hours postoperatively | 
| return of gastrointestinal function | interval from the end of surgery until first gas elimination postoperatively. interval from the end of surgery until first feces elimination postoperatively. | during the 48 hours postoperatively | 
| sedation | 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. | Hour 0 | 
| sedation | 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. | Hour 2 | 
| sedation | 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. | Hour 6 | 
| sedation | 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. | Hour 12 | 
| sedation | 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. | Hour 24 | 
| sedation | 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. | Hour 36 | 
| sedation | 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. | Hour 48 | 
| incidence of neurological alterations | 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. | Hour 0 | 
| incidence of neurological alterations | 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. | Hour 2 | 
| incidence of neurological alterations | 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. | Hour 6 | 
| incidence of neurological alterations | 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. | Hour 12 | 
| incidence of neurological alterations | 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. | Hour 24 | 
| incidence of neurological alterations | 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. | Hour 36 | 
| incidence of neurological alterations | 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. | Hour 48 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ropivacaine, wound infusion, analgesia, cesarean, intrathecal morphine, randomized controlled trial