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

S

Saint-Joseph University

Status and phase

Completed
Phase 4

Conditions

Obstetric Pain

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03502642
CEHDF944

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups, including a placebo group

Placebo (P)
Placebo Comparator group
Description:
Placebo group parturients will receive spinal anesthesia with intrathecal morphine and will have continuous normal saline wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain).
Treatment:
Device: wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain)
Drug: intrathecal morphine
Procedure: Spinal Anesthesia
Drug: Normal saline
Ropivacaine (R)
Active Comparator group
Description:
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).
Treatment:
Device: wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain)
Drug: Ropivacaine (Ropivacaina Molteni®)
Procedure: Spinal Anesthesia

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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