Obstetric PainPhase 4NCT03502642
Ropivacaine Continuous Wound Infusion Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery
A Phase 4 study testing wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain), Spinal Anesthesia and intrathecal morphine in people with Obstetric Pain, run by Saint-Joseph University at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstetric Pain
- What is being tested?
- wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain), Spinal Anesthesia and intrathecal morphine
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteLebanon
- Study dates
- 29 May 2017to 29 Jun 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ropivacaine Continuous Wound Infusion Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery : A Randomized Controlled Trial
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.
Read more
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
- Being tested
- wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain), Spinal Anesthesia, intrathecal morphine, Ropivacaine (Ropivacaina Molteni®), Normal saline
- Keywords
- Ropivacaine, wound infusion, analgesia, cesarean, intrathecal morphine, randomized controlled trial
- Medical subject headings
- Labor Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain)Device
Also called wound catheter
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 AnesthesiaProcedure or surgery
Cesarean section was conducted under spinal anesthesia in both groups
intrathecal morphineDrug
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 salineDrug
Also called Placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Device: wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain); Procedure: Spinal Anesthesia; Drug: Ropivacaine (Ropivacaina Molteni®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Hour 48
Secondary outcomes (37)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Hour 48
incidence of urinary retention
defined as the requirement of bladder recatheterization postoperatively.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Hour 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2018
- Study start29 May 2017
- Primary completion29 May 2018
- Study completion29 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Collaborators
- LEVENTON
- Responsible party
- Principal investigator, Hicham Abou Zeid, Saint-Joseph University
- Investigators
- Hicham A Abou Zeid, M.D., Study chair, Saint Joseph University- LebanonNicole M Naccahe, M.D., Study director, Saint Joseph University- LebanonSamer H Hotayt, M.D., Principal investigator, Saint Joseph University- Lebanon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03502642
- Sponsor's protocol ID
- CEHDF944
- Status last verified
- Oct 2018
- First submitted
- 23 Mar 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ropivacaine Continuous Wound Infusion Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03502642
- Acronym / sponsor ID
- CEHDF944
- Conditions
- Obstetric Pain
- Keywords
- Ropivacaine, wound infusion, analgesia, cesarean, intrathecal morphine, randomized controlled trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Collaborators
- LEVENTON
- Study start
- 29 May 2017 (actual)
- Primary completion
- 29 May 2018 (actual)
- Study completion
- 29 Jun 2018 (actual)
- First posted
- 19 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Placebo (P) | Placebo comparator | Device: wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain), Procedure: Spinal Anesthesia, Drug: intrathecal morphine, Drug: Normal salinePlacebo 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 | Device: wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain), Procedure: Spinal Anesthesia, Drug: Ropivacaine (Ropivacaina Molteni®)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). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain)Also: wound catheterAfter 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. | Device | Placebo (P), Ropivacaine (R) |
| Spinal AnesthesiaCesarean section was conducted under spinal anesthesia in both groups | Procedure or surgery | Placebo (P), Ropivacaine (R) |
| intrathecal morphineIntrathecal morphine was administered during spinal anesthesia in the placebo group but not in the ropivacaine group | Drug | Placebo (P) |
| 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 | Ropivacaine (R) |
| Normal salineAlso: PlaceboA10ml 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. | Drug | Placebo (P) |
Primary outcome
pain at rest
Time frame: Hour 0, Hour 2, Hour 6, Hour 12, Hour 24, Hour 36 and Hour 48
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.
pain at rest
Time frame: Hour 2
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.
pain at rest
Time frame: Hour 6
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.
pain at rest
Time frame: Hour 12
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.
pain at rest
Time frame: Hour 24
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.
pain at rest
Time frame: Hour 36
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.
pain at rest
Time frame: Hour 48
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.
37 secondary outcomes
pain at mobilization
Time frame: Hour 0
pain at mobilization
Time frame: Hour 2
pain at mobilization
Time frame: Hour 6
pain at mobilization
Time frame: Hour 12
pain at mobilization
Time frame: Hour 24
pain at mobilization
Time frame: Hour 36
pain at mobilization
Time frame: Hour 48
incidence of postoperative nausea and vomiting
Time frame: Hour 0
incidence of postoperative nausea and vomiting
Time frame: Hour 2
incidence of postoperative nausea and vomiting
Time frame: Hour 6
incidence of postoperative nausea and vomiting
Time frame: Hour 12
incidence of postoperative nausea and vomiting
Time frame: Hour 24
incidence of postoperative nausea and vomiting
Time frame: Hour 36
incidence of postoperative nausea and vomiting
Time frame: Hour 48
incidence of pruritus
Time frame: Hour 0
incidence of pruritus
Time frame: Hour 2
incidence of pruritus
Time frame: Hour 6
incidence of pruritus
Time frame: Hour 12
incidence of pruritus
Time frame: Hour 24
incidence of pruritus
Time frame: Hour 36
incidence of pruritus
Time frame: Hour 48
incidence of urinary retention
Time frame: during the 48 hours postoperatively
return of gastrointestinal function
Time frame: during the 48 hours postoperatively
sedation
Time frame: Hour 0
sedation
Time frame: Hour 2
sedation
Time frame: Hour 6
sedation
Time frame: Hour 12
sedation
Time frame: Hour 24
sedation
Time frame: Hour 36
sedation
Time frame: Hour 48
incidence of neurological alterations
Time frame: Hour 0
incidence of neurological alterations
Time frame: Hour 2
incidence of neurological alterations
Time frame: Hour 6
incidence of neurological alterations
Time frame: Hour 12
incidence of neurological alterations
Time frame: Hour 24
incidence of neurological alterations
Time frame: Hour 36
incidence of neurological alterations
Time frame: Hour 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hicham A Abou Zeid, M.D. study chair
Saint Joseph University- Lebanon
Nicole M Naccahe, M.D. study director
Saint Joseph University- Lebanon
Samer H Hotayt, M.D. principal investigator
Saint Joseph University- Lebanon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain), Spinal Anesthesia and intrathecal morphine in people with Obstetric Pain, run by Saint-Joseph University at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain at rest (time frame: Hour 0, Hour 2, Hour 6, Hour 12, Hour 24, Hour 36 and Hour 48). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.