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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
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.
Cesarean section was conducted under spinal anesthesia in both groups
Intrathecal morphine was administered during spinal anesthesia in the placebo group but not in the ropivacaine group
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.
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.
Hotel Dieu de France Hospital
Beirut, Lebanon
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Hour 48
pain at mobilization
Pain scores at mobilization 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.
Time frame: Hour 0
pain at mobilization
Pain scores at mobilization 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.
Time frame: Hour 2
pain at mobilization
Pain scores at mobilization 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.
Time frame: Hour 6
pain at mobilization
Pain scores at mobilization 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.
Time frame: Hour 12
pain at mobilization
Pain scores at mobilization 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.
Time frame: Hour 24
pain at mobilization
Pain scores at mobilization 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.
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Time frame: Hour 36
pain at mobilization
Pain scores at mobilization 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.
Time frame: Hour 48
incidence of postoperative nausea and vomiting
incidence of postoperative nausea and vomiting. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time frame: Hour 0
incidence of postoperative nausea and vomiting
incidence of postoperative nausea and vomiting. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time frame: Hour 2
incidence of postoperative nausea and vomiting
incidence of postoperative nausea and vomiting. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time frame: Hour 6
incidence of postoperative nausea and vomiting
incidence of postoperative nausea and vomiting. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time frame: Hour 12
incidence of postoperative nausea and vomiting
incidence of postoperative nausea and vomiting. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time frame: Hour 24
incidence of postoperative nausea and vomiting
incidence of postoperative nausea and vomiting. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time frame: Hour 36
incidence of postoperative nausea and vomiting
incidence of postoperative nausea and vomiting. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time frame: Hour 48
incidence of pruritus
incidence of pruritus. Measurements were made for 48 hours postoperatively.Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time frame: Hour 0
incidence of pruritus
incidence of pruritus. Measurements were made for 48 hours postoperatively.Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time frame: Hour 2
incidence of pruritus
incidence of pruritus. Measurements were made for 48 hours postoperatively.Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time frame: Hour 6
incidence of pruritus
incidence of pruritus. Measurements were made for 48 hours postoperatively.Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time frame: Hour 12
incidence of pruritus
incidence of pruritus. Measurements were made for 48 hours postoperatively.Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time frame: Hour 24
incidence of pruritus
incidence of pruritus. Measurements were made for 48 hours postoperatively.Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time frame: Hour 36
incidence of pruritus
incidence of pruritus. Measurements were made for 48 hours postoperatively.Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time frame: Hour 48
incidence of urinary retention
defined as the requirement of bladder recatheterization postoperatively.
Time frame: during the 48 hours postoperatively
return of gastrointestinal function
interval from the end of surgery until first gas elimination postoperatively. interval from the end of surgery until first feces elimination postoperatively.
Time frame: during the 48 hours postoperatively
sedation
assessed by a 5-point rating scale (0 fully alert, 1 sleepy but easily aroused with verbal stimulation, 2 sleepy but aroused with light touch, 3 sleepy but aroused with pain, and 4 unconscious patient). Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time frame: Hour 0
sedation
assessed by a 5-point rating scale (0 fully alert, 1 sleepy but easily aroused with verbal stimulation, 2 sleepy but aroused with light touch, 3 sleepy but aroused with pain, and 4 unconscious patient). Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time frame: Hour 2
sedation
assessed by a 5-point rating scale (0 fully alert, 1 sleepy but easily aroused with verbal stimulation, 2 sleepy but aroused with light touch, 3 sleepy but aroused with pain, and 4 unconscious patient). Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time frame: Hour 6
sedation
assessed by a 5-point rating scale (0 fully alert, 1 sleepy but easily aroused with verbal stimulation, 2 sleepy but aroused with light touch, 3 sleepy but aroused with pain, and 4 unconscious patient). Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time frame: Hour 12
sedation
assessed by a 5-point rating scale (0 fully alert, 1 sleepy but easily aroused with verbal stimulation, 2 sleepy but aroused with light touch, 3 sleepy but aroused with pain, and 4 unconscious patient). Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time frame: Hour 24
sedation
assessed by a 5-point rating scale (0 fully alert, 1 sleepy but easily aroused with verbal stimulation, 2 sleepy but aroused with light touch, 3 sleepy but aroused with pain, and 4 unconscious patient). Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time frame: Hour 36
sedation
assessed by a 5-point rating scale (0 fully alert, 1 sleepy but easily aroused with verbal stimulation, 2 sleepy but aroused with light touch, 3 sleepy but aroused with pain, and 4 unconscious patient). Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time frame: Hour 48
incidence of neurological alterations
patients were specifically asked about paresthesia, tactile hyperesthesia, and headache. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time frame: Hour 0
incidence of neurological alterations
patients were specifically asked about paresthesia, tactile hyperesthesia, and headache. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time frame: Hour 2
incidence of neurological alterations
patients were specifically asked about paresthesia, tactile hyperesthesia, and headache. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time frame: Hour 6
incidence of neurological alterations
patients were specifically asked about paresthesia, tactile hyperesthesia, and headache. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time frame: Hour 12
incidence of neurological alterations
patients were specifically asked about paresthesia, tactile hyperesthesia, and headache. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time frame: Hour 24
incidence of neurological alterations
patients were specifically asked about paresthesia, tactile hyperesthesia, and headache. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time frame: Hour 36
incidence of neurological alterations
patients were specifically asked about paresthesia, tactile hyperesthesia, and headache. Measurements were made for 48 hours postoperatively. Hour 0 is the time of arrival to the post anesthesia care unit PACU.
Time frame: Hour 48