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| Name | Class |
|---|---|
| LEVENTON | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Hour 0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hotel Dieu de France Hospital | Beirut | 166830 | Lebanon |
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randomized controlled trial
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healthy, term women scheduled for cesarean delievry
|
|
| Spinal Anesthesia | Procedure | Cesarean section was conducted under spinal anesthesia in both groups |
|
| intrathecal morphine | Drug | Intrathecal morphine was administered during spinal anesthesia in the placebo group but not in the ropivacaine group |
|
| 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. |
|
| 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. |
|
|
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 |
| 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Hour 48 |
| incidence of urinary retention | defined as the requirement of bladder recatheterization postoperatively. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Hour 48 |
| ID | Term |
|---|---|
| D048949 | Labor Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000775 | Anesthesia, Spinal |
| D000077212 | Ropivacaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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