Preemptive Ketorolac for Shoulder Tip Pain During Cesarean Section
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|ClinicalTrials.gov Identifier: NCT02380898|
Recruitment Status : Completed
First Posted : March 5, 2015
Last Update Posted : September 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cesarean Section||Drug: Ketorolac Drug: Normal saline||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Preemptive Ketorolac for Intraoperative Shoulder Tip Pain During Cesarean Section: A Double‑Blind Randomized Clinical Trial.|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
30 mg ketorolac immediately before induction of anesthesia
|Placebo Comparator: Normal saline 0.9%||
Drug: Normal saline
4 mL normal saline 0.9% immediately before induction of anesthesia
- Intraoperative shoulder tip pain [ Time Frame: intraoperative ]
- pain score VAS [ Time Frame: intraoperative ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02380898
|Assiut University hospital|
|Assiut, Egypt, 11111|