Clinical trial NCT03502642: Ropivacaine Continuous Wound Infusion Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery
Official title: Ropivacaine Continuous Wound Infusion Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obstetric Pain
Keywords: Ropivacaine
wound infusion
analgesia
cesarean
intrathecal morphine
randomized controlled trial
Lead sponsor: Saint-Joseph University
Sponsor class: OTHER
Collaborators: name: LEVENTON
First posted: 2018-04-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: pain at rest
timeFrame: Hour 0, Hour 2, Hour 6, Hour 12, Hour 24, Hour 36 and Hour 48
measure: pain at rest
timeFrame: Hour 2
measure: pain at rest
timeFrame: Hour 6
measure: pain at rest
timeFrame: Hour 12
measure: pain at rest
timeFrame: Hour 24
measure: pain at rest
timeFrame: Hour 36
measure: pain at rest
timeFrame: Hour 48
Secondary outcomes:
measure: pain at mobilization
timeFrame: Hour 0
measure: pain at mobilization
timeFrame: Hour 2
measure: pain at mobilization
timeFrame: Hour 6
measure: pain at mobilization
timeFrame: Hour 12
measure: pain at mobilization
timeFrame: Hour 24
measure: pain at mobilization
timeFrame: Hour 36
measure: pain at mobilization
timeFrame: Hour 48
measure: incidence of postoperative nausea and vomiting
timeFrame: Hour 0
measure: incidence of postoperative nausea and vomiting
timeFrame: Hour 2
measure: incidence of postoperative nausea and vomiting
timeFrame: Hour 6
measure: incidence of postoperative nausea and vomiting
timeFrame: Hour 12
measure: incidence of postoperative nausea and vomiting
timeFrame: Hour 24
measure: incidence of postoperative nausea and vomiting
timeFrame: Hour 36
measure: incidence of postoperative nausea and vomiting
timeFrame: Hour 48
measure: incidence of pruritus
timeFrame: Hour 0
measure: incidence of pruritus
timeFrame: Hour 2
measure: incidence of pruritus
timeFrame: Hour 6
measure: incidence of pruritus
timeFrame: Hour 12
measure: incidence of pruritus
timeFrame: Hour 24
measure: incidence of pruritus
timeFrame: Hour 36
measure: incidence of pruritus
timeFrame: Hour 48
measure: incidence of urinary retention
timeFrame: during the 48 hours postoperatively
measure: return of gastrointestinal function
timeFrame: during the 48 hours postoperatively
measure: sedation
timeFrame: Hour 0
measure: sedation
timeFrame: Hour 2
measure: sedation
timeFrame: Hour 6
measure: sedation
timeFrame: Hour 12
measure: sedation
timeFrame: Hour 24
measure: sedation
timeFrame: Hour 36
measure: sedation
timeFrame: Hour 48
measure: incidence of neurological alterations
timeFrame: Hour 0
measure: incidence of neurological alterations
timeFrame: Hour 2
measure: incidence of neurological alterations
timeFrame: Hour 6
measure: incidence of neurological alterations
timeFrame: Hour 12
measure: incidence of neurological alterations
timeFrame: Hour 24
measure: incidence of neurological alterations
timeFrame: Hour 36
measure: incidence of neurological alterations
timeFrame: Hour 48
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Hotel Dieu de France Hospital
Study officials:
affiliation: Saint Joseph University- Lebanon
name: Hicham A Abou Zeid, M.D.
role: STUDY_CHAIR
affiliation: Saint Joseph University- Lebanon
name: Nicole M Naccahe, M.D.
role: STUDY_DIRECTOR
affiliation: Saint Joseph University- Lebanon
name: Samer H Hotayt, M.D.
role: PRINCIPAL_INVESTIGATOR
References: