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

Obstetric Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03502642
• Other study ID #: CEHDF944
• Status: Completed
• Phase: Phase 4
• Start date: May 29, 2017
• Est. completion date: June 29, 2018

Study information

• Verified date: October 2018
• Source: Saint-Joseph University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 29, 2018
• Est. primary completion date: May 29, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Labor Pain
• Obstetric Pain

Intervention

Device:
• wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain)
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.

Procedure:
• Spinal Anesthesia
Cesarean section was conducted under spinal anesthesia in both groups

Drug:
• intrathecal morphine
Intrathecal morphine was administered during spinal anesthesia in the placebo group but not in the ropivacaine group
• Ropivacaine (Ropivacaina Molteni®)
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.
• Normal saline
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.

Locations

Country	Name	City	State
Lebanon	Hotel Dieu de France Hospital	Beirut

Sponsors (2)

Lead Sponsor	Collaborator
Saint-Joseph University	LEVENTON

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	incidence of urinary retention	defined as the requirement of bladder recatheterization postoperatively.	during the 48 hours postoperatively
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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