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Completed

NCT Number: NCT03502642

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

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.

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Key information

Conditions

Obstetric Pain Agnosia Labor Pain Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hotel Dieu de France Hospital

Beirut, 166830, Lebanon

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain)

Device

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 names: wound catheter

Spinal anesthesia

Procedure

Cesarean section was conducted under spinal anesthesia in both groups

Intrathecal morphine

Drug

Intrathecal morphine was administered during spinal anesthesia in the placebo group but not in the ropivacaine group

Ropivacaine (Ropivacaina Molteni®)

Drug

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

Drug

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 names: Placebo

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Saint-Joseph University

Other

Collaborators

  • LEVENTON

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 19, 2018
Registry last updated
Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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