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

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

Interventions

DEVICE

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.

PROCEDURE

Spinal Anesthesia

Cesarean section was conducted under spinal anesthesia in both groups

DRUG

intrathecal morphine

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

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.

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.

Sponsors & Collaborators

• LEVENTON

  collaborator UNKNOWN

• Saint-Joseph University

  lead OTHER

Principal Investigators

• Hicham A Abou Zeid, M.D. · Saint Joseph University- Lebanon

• Nicole M Naccahe, M.D. · Saint Joseph University- Lebanon

• Samer H Hotayt, M.D. · Saint Joseph University- Lebanon

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-05-29

Primary Completion

2018-05-29

Completion

2018-06-29

Countries

• Lebanon

Study Locations