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

NCT03502642 | Completed Phase 4

• 1 other identifier: CEHDF944
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstetric Pain

Keywords

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

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (37)

• pain at mobilization

  Hour 0

• pain at mobilization

  Hour 2

• pain at mobilization

  Hour 6

• pain at mobilization

  Hour 12

• pain at mobilization

  Hour 24

Study Arms (2)

Placebo (P)

PLACEBO COMPARATOR

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); Procedure: Spinal Anesthesia; Drug: intrathecal morphine; Drug: Normal saline

Ropivacaine (R)

ACTIVE COMPARATOR

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); Procedure: Spinal Anesthesia; Drug: Ropivacaine (Ropivacaina Molteni®)

Interventions

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.

Also known as: wound catheter

Placebo (P); Ropivacaine (R)

Spinal Anesthesia PROCEDURE

Cesarean section was conducted under spinal anesthesia in both groups

Placebo (P); Ropivacaine (R)

intrathecal morphine DRUG

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

Placebo (P)

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.

Ropivacaine (R)

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.

Also known as: Placebo

Placebo (P)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saint-Joseph University: lead
• LEVENTON: collaborator

Study Sites (1)

Hotel Dieu de France Hospital

Beirut, 166830, Lebanon

Location

MeSH Terms

Conditions

Labor Pain; Agnosia

Interventions

Anesthesia, Spinal; Ropivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Hicham A Abou Zeid, M.D.

  Saint Joseph University- Lebanon

  STUDY CHAIR

• Nicole M Naccahe, M.D.

  Saint Joseph University- Lebanon

  STUDY DIRECTOR

• Samer H Hotayt, M.D.

  Saint Joseph University- Lebanon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: healthy, term women scheduled for cesarean delievry
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: April 19, 2018
• Study Start: May 29, 2017
• Primary Completion: May 29, 2018
• Study Completion: June 29, 2018
• Last Updated: October 9, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)