Clinical trial NCT02380898: Preemptive Ketorolac for Shoulder Tip Pain During Cesarean Section
Official title: Preemptive Ketorolac for Intraoperative Shoulder Tip Pain During Cesarean Section: A Double-Blind Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cesarean Section
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2015-03-05
Enrollment: 200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* nulligravida healthy women who delivered single term baby, with American Society of Anesthesiologists physical status 1 or 2

Exclusion Criteria:

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

Primary outcomes:
measure: Intraoperative shoulder tip pain
timeFrame: intraoperative
Secondary outcomes:
measure: pain score VAS
timeFrame: intraoperative
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University hospital
Study officials:
References:
citation: 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.