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

• ClinicalTrials.gov Identifier: NCT03502642
• Recruitment Status: Completed
• First Posted: April 19, 2018
• Last Update Posted: October 9, 2018
• Sponsor: Saint-Joseph University
• Collaborator: LEVENTON
• Information provided by (Responsible Party): Hicham Abou Zeid, Saint-Joseph University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Obstetric Pain	Device: wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain); Procedure: Spinal Anesthesia; Drug: intrathecal morphine; Drug: Ropivacaine (Ropivacaina Molteni®); Drug: Normal saline	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: randomized controlled trial
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Masking Description: healthy, term women scheduled for cesarean delievry
• Primary Purpose: Treatment
• Official Title: Ropivacaine Continuous Wound Infusion Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery : A Randomized Controlled Trial
• Actual Study Start Date: May 29, 2017
• Actual Primary Completion Date: May 29, 2018
• Actual Study Completion Date: June 29, 2018

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo (P); 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); 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.; Other Name: wound catheter; 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; Drug: 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.; Other Name: Placebo
Active Comparator: Ropivacaine (R); 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); 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.; Other Name: wound catheter; Procedure: Spinal Anesthesia; Cesarean section was conducted under spinal anesthesia in both groups; Drug: 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.

Outcome Measures

Primary Outcome Measures :

1. pain at rest [ Time Frame: Hour 0, Hour 2, Hour 6, Hour 12, Hour 24, Hour 36 and 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.
2. pain at rest [ Time Frame: Hour 2 ]
   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.
3. pain at rest [ Time Frame: Hour 6 ]
   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.
4. pain at rest [ Time Frame: Hour 12 ]
   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.
5. pain at rest [ Time Frame: Hour 24 ]
   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.
6. pain at rest [ Time Frame: Hour 36 ]
   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.
7. pain at rest [ Time Frame: 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 :

1. pain at mobilization [ Time Frame: Hour 0 ]
   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.
2. pain at mobilization [ Time Frame: Hour 2 ]
   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.
3. pain at mobilization [ Time Frame: Hour 6 ]
   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.
4. pain at mobilization [ Time Frame: Hour 12 ]
   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.
5. pain at mobilization [ Time Frame: Hour 24 ]
   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.
6. pain at mobilization [ Time Frame: Hour 36 ]
   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.
7. pain at mobilization [ Time Frame: 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.
8. incidence of postoperative nausea and vomiting [ Time Frame: Hour 0 ]
   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.
9. incidence of postoperative nausea and vomiting [ Time Frame: Hour 2 ]
   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.
10. incidence of postoperative nausea and vomiting [ Time Frame: Hour 6 ]
    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.
11. incidence of postoperative nausea and vomiting [ Time Frame: Hour 12 ]
    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.
12. incidence of postoperative nausea and vomiting [ Time Frame: Hour 24 ]
    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.
13. incidence of postoperative nausea and vomiting [ Time Frame: Hour 36 ]
    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.
14. incidence of postoperative nausea and vomiting [ Time Frame: 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.
15. incidence of pruritus [ Time Frame: Hour 0 ]
    incidence of pruritus. Measurements were made for 48 hours postoperatively.Hour 0 is the time of arrival to the post anesthesia care unit PACU.
16. incidence of pruritus [ Time Frame: Hour 2 ]
    incidence of pruritus. Measurements were made for 48 hours postoperatively.Hour 0 is the time of arrival to the post anesthesia care unit PACU.
17. incidence of pruritus [ Time Frame: Hour 6 ]
    incidence of pruritus. Measurements were made for 48 hours postoperatively.Hour 0 is the time of arrival to the post anesthesia care unit PACU.
18. incidence of pruritus [ Time Frame: Hour 12 ]
    incidence of pruritus. Measurements were made for 48 hours postoperatively.Hour 0 is the time of arrival to the post anesthesia care unit PACU.
19. incidence of pruritus [ Time Frame: Hour 24 ]
    incidence of pruritus. Measurements were made for 48 hours postoperatively.Hour 0 is the time of arrival to the post anesthesia care unit PACU.
20. incidence of pruritus [ Time Frame: Hour 36 ]
    incidence of pruritus. Measurements were made for 48 hours postoperatively.Hour 0 is the time of arrival to the post anesthesia care unit PACU.
21. incidence of pruritus [ Time Frame: 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.
22. incidence of urinary retention [ Time Frame: during the 48 hours postoperatively ]
    defined as the requirement of bladder recatheterization postoperatively.
23. return of gastrointestinal function [ Time Frame: 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.
24. sedation [ Time Frame: Hour 0 ]

    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.

25. sedation [ Time Frame: Hour 2 ]

    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.

26. sedation [ Time Frame: Hour 6 ]

    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.

27. sedation [ Time Frame: Hour 12 ]

    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.

28. sedation [ Time Frame: Hour 24 ]

    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.

29. sedation [ Time Frame: Hour 36 ]

    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.

30. sedation [ Time Frame: 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.

31. incidence of neurological alterations [ Time Frame: Hour 0 ]
    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.
32. incidence of neurological alterations [ Time Frame: Hour 2 ]
    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.
33. incidence of neurological alterations [ Time Frame: Hour 6 ]
    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.
34. incidence of neurological alterations [ Time Frame: Hour 12 ]
    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.
35. incidence of neurological alterations [ Time Frame: Hour 24 ]
    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.
36. incidence of neurological alterations [ Time Frame: Hour 36 ]
    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.
37. incidence of neurological alterations [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Lebanon

Hotel Dieu de France Hospital

Beirut, Lebanon, 166830

Sponsors and Collaborators

Saint-Joseph University

LEVENTON

Investigators

• Study Chair: Hicham A Abou Zeid, M.D.; Saint Joseph University- Lebanon
• Study Director: Nicole M Naccahe, M.D.; Saint Joseph University- Lebanon
• Principal Investigator: Samer H Hotayt, M.D.; Saint Joseph University- Lebanon

More Information

• Responsible Party: Hicham Abou Zeid, Assistant Professor, Saint-Joseph University
• ClinicalTrials.gov Identifier: NCT03502642
• Other Study ID Numbers: CEHDF944
• First Posted: April 19, 2018
• Last Update Posted: October 9, 2018
• Last Verified: October 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Hicham Abou Zeid, Saint-Joseph University:

Ropivacaine; wound infusion; analgesia; cesarean; intrathecal morphine; randomized controlled trial

Additional relevant MeSH terms:

Labor Pain; Pain; Neurologic Manifestations; Morphine; Ropivacaine; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics, Opioid; Narcotics; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Anesthetics, Local