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

NCT ID: NCT03502642

Last Updated: 2018-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-29
• Study Completion Date: 2018-06-29

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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).

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: 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.

Spinal Anesthesia

Intervention Type: PROCEDURE

Cesarean section was conducted under spinal anesthesia in both groups

intrathecal morphine

Intervention Type: DRUG

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

Normal saline

Intervention Type: 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.

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).

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Spinal Anesthesia

Intervention Type: PROCEDURE

Cesarean section was conducted under spinal anesthesia in both groups

Ropivacaine (Ropivacaina Molteni®)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Spinal Anesthesia

Cesarean section was conducted under spinal anesthesia in both groups

Intervention Type: PROCEDURE

intrathecal morphine

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

wound catheter; Placebo

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

LEVENTON

UNKNOWN

Sponsor Role: collaborator

Saint-Joseph University

OTHER

Sponsor Role: lead

Responsible Party

Hicham Abou Zeid

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hicham A Abou Zeid, M.D.

Role: STUDY_CHAIR

Saint Joseph University- Lebanon

Nicole M Naccahe, M.D.

Role: STUDY_DIRECTOR

Saint Joseph University- Lebanon

Samer H Hotayt, M.D.

Role: PRINCIPAL_INVESTIGATOR

Saint Joseph University- Lebanon

Locations

Hotel Dieu de France Hospital

Beirut, , Lebanon

Countries

Lebanon

Other Identifiers

CEHDF944

Identifier Type: -

Identifier Source: org_study_id