Cesarean SectionPhase 4NCT02380898
Preemptive Ketorolac for Shoulder Tip Pain During Cesarean Section
A Phase 4 study testing Ketorolac and Normal saline in people with Cesarean Section, run by Assiut University at 1 site in Egypt.
Trial summary
Our study is planned to investigate if pre-emptive Ketorolac would decrease the incidence of intraoperative shoulder tip pain and improve discomfort during Caesarean section. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Ketorolac and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2015to Sep 2015
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- nulligravida healthy women who delivered single term baby, with American Society of Anesthesiologists physical status 1 or 2
Who cannot join
- previous caesarean section; pre-eclampsia; gestational diabetes; trauma; fractures or chronic pain in shoulder joints, forearms, upper limbs; cardiovascular or biliary system disorders; women undergoing emergency caesarean; previous history of abdominal surgery; conditions preventing spinal block, including local infection; coagulopathies; haemodynamic instability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preemptive Ketorolac for Intraoperative Shoulder Tip Pain During Cesarean Section: A Double-Blind Randomized Clinical Trial.
Our study is planned to investigate if pre-emptive Ketorolac would decrease the incidence of intraoperative shoulder tip pain and improve discomfort during Caesarean section.
Read the detailed description
Cesarean section (CS) is the most frequent major abdominal surgery among women worldwide . Shoulder pain, is a common but mostly neglected consequence of caesarean section and little is known about this entity. The pain is described as sharp, deep and referred, usually begins intraoperatively and continue for 2-3 days after surgery.
Although infant and maternal death rates have been decreased after CS, this procedure is not free of risks for mother and child. Compared with normal vaginal delivery (NVD), some CS complications include: more haemorrhage; increased postoperative pain; atelectasia; nausea; vomiting; risks for wound infection or wound opening and shoulder pain.
Although spinal anaesthesia (SA) is a common technique for CS in the past decade, and there are many studies about CS complications, there are few studies about shoulder pain as one of CS complications. Kikuchi et al. reported that women undergoing cesarean section under compined spinal epidural anaethesia experience shoulder-tip pain with great frequency. Our study was planned and performed to investigate if pre-emptive Ketorolac would decrease the incidence of intraoperative shoulder pain and improve discomfort during CS.
Sharp pain observed in these patients was experienced in the shoulder area or under the diaphragm. The pain was described as coming from deep within the shoulder, and in some, would seem to radiate from the right chest. The pain spread down the upper right arm and up the right neck in some, resulting in muscular tension and pain. The cause of this pain is postulated to sub-diaphragmatic air trapping, subdiaphragmatic clot or peritoneal irritation. This type of shoulder pain is reported commonly after laparoscopic surgery and it is reported that heat, massage and drinking hot water or hot tea with fresh lemon relieves this pain.
- Conditions
- Cesarean Section
- Being tested
- Ketorolac, Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetorolacDrug
30 mg ketorolac immediately before induction of anesthesia
Normal salineDrug
4 mL normal saline 0.9% immediately before induction of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Ketorolac | Experimental | Not described Receives: Drug: Ketorolac |
| Normal saline 0.9% | Placebo comparator | Not described Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative shoulder tip pain
Measured: intraoperative
Secondary outcomes (1)
pain score VAS
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Samy Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02380898
- Sponsor's protocol ID
- Ketorolac
- Status last verified
- Dec 2015
- First submitted
- 1 Mar 2015
- Last updated
- 14 Sep 2017
- Results posted
- No
Publications
Abbas MS, Askar OA, Abdel Aleem AA. Pre-emptive ketorolac for prevention of intraoperative shoulder pain in patients undergoing cesarean section: A double blind randomized clinical trial. Asian J Anesthesiol. 2017 Sep;55(3):68-72. doi: 10.1016/j.aja.2017.07.002. Epub 2017 Sep 20.
PubMed 28993164
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preemptive Ketorolac for Intraoperative Shoulder Tip Pain During Cesarean Section: A Double-Blind Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT02380898
- Acronym / sponsor ID
- Ketorolac
- Conditions
- Cesarean Section
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 5 Mar 2015 (estimated)
- 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.
Our study is planned to investigate if pre-emptive Ketorolac would decrease the incidence of intraoperative shoulder tip pain and improve discomfort during Caesarean section.
Detailed description
Cesarean section (CS) is the most frequent major abdominal surgery among women worldwide . Shoulder pain, is a common but mostly neglected consequence of caesarean section and little is known about this entity. The pain is described as sharp, deep and referred, usually begins intraoperatively and continue for 2-3 days after surgery.
Although infant and maternal death rates have been decreased after CS, this procedure is not free of risks for mother and child. Compared with normal vaginal delivery (NVD), some CS complications include: more haemorrhage; increased postoperative pain; atelectasia; nausea; vomiting; risks for wound infection or wound opening and shoulder pain.
Although spinal anaesthesia (SA) is a common technique for CS in the past decade, and there are many studies about CS complications, there are few studies about shoulder pain as one of CS complications. Kikuchi et al. reported that women undergoing cesarean section under compined spinal epidural anaethesia experience shoulder-tip pain with great frequency. Our study was planned and performed to investigate if pre-emptive Ketorolac would decrease the incidence of intraoperative shoulder pain and improve discomfort during CS.
Sharp pain observed in these patients was experienced in the shoulder area or under the diaphragm. The pain was described as coming from deep within the shoulder, and in some, would seem to radiate from the right chest. The pain spread down the upper right arm and up the right neck in some, resulting in muscular tension and pain. The cause of this pain is postulated to sub-diaphragmatic air trapping, subdiaphragmatic clot or peritoneal irritation. This type of shoulder pain is reported commonly after laparoscopic surgery and it is reported that heat, massage and drinking hot water or hot tea with fresh lemon relieves this pain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketorolac | Experimental | Drug: Ketorolac |
| Normal saline 0.9% | Placebo comparator | Drug: Normal saline |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- nulligravida healthy women who delivered single term baby, with American Society of Anesthesiologists physical status 1 or 2
Key exclusion criteria (1 listed)
- previous caesarean section; pre-eclampsia; gestational diabetes; trauma; fractures or chronic pain in shoulder joints, forearms, upper limbs; cardiovascular or biliary system disorders; women undergoing emergency caesarean; previous history of abdominal surgery; conditions preventing spinal block, including local infection; coagulopathies; haemodynamic instability
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 |
|---|---|---|
| Ketorolac30 mg ketorolac immediately before induction of anesthesia | Drug | Ketorolac |
| Normal saline4 mL normal saline 0.9% immediately before induction of anesthesia | Drug | Normal saline 0.9% |
Primary outcome
Intraoperative shoulder tip pain
Time frame: intraoperative
1 secondary outcome
pain score VAS
Time frame: intraoperative
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 14 Sep 2017.
- Derived from this study: PubMed 28993164Abbas MS, Askar OA, Abdel Aleem AA. Pre-emptive ketorolac for prevention of intraoperative shoulder pain in patients undergoing cesarean section: A double blind randomized clinical trial. Asian J Anesthesiol. 2017 Sep;55(3):68-72. doi: 10.1016/j.aja.2017.07.002. Epub 2017 Sep 20.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ketorolac and Normal saline in people with Cesarean Section, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 1 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 14 Sep 2017. 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 Egypt. 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?
Intraoperative shoulder tip pain (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02380898, which also lists 1 linked publication.
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 14 Sep 2017.