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Preemptive Ketorolac for Shoulder Tip Pain During Cesarean Section

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02380898
Recruitment Status : Completed
First Posted : March 5, 2015
Last Update Posted : September 14, 2017
Information provided by (Responsible Party):
Mostafa Samy Abbas, Assiut University

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.

Condition or disease Intervention/treatment Phase
Cesarean Section Drug: Ketorolac Drug: Normal saline Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section
Drug Information available for: Ketorolac

Arm Intervention/treatment
Experimental: Ketorolac Drug: Ketorolac
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

Primary Outcome Measures :
  1. Intraoperative shoulder tip pain [ Time Frame: intraoperative ]

Secondary Outcome Measures :
  1. pain score VAS [ Time Frame: intraoperative ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02380898

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Assiut University hospital
Assiut, Egypt, 11111
Sponsors and Collaborators
Assiut University

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Mostafa Samy Abbas, lecturer of anesthesia and ICU, Assiut University,Assiut, Egypt, Assiut University Identifier: NCT02380898    
Other Study ID Numbers: Ketorolac
First Posted: March 5, 2015    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: December 2015
Additional relevant MeSH terms:
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Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action