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Completed

NCT Number: NCT02380898

Preemptive Ketorolac for Shoulder Tip Pain During Cesarean Section

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.

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Key information

Conditions

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Assiut University hospital

Asyut, 11111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketorolac

Drug

30 mg ketorolac immediately before induction of anesthesia

normal saline

Drug

4 mL normal saline 0.9% immediately before induction of anesthesia

Primary outcomes

  1. Intraoperative shoulder tip pain

    Time frame: intraoperative

Secondary outcomes

  1. pain score VAS

    Time frame: intraoperative

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Preemptive Ketorolac for Intraoperative Shoulder Tip Pain During Cesarean Section: A Double-Blind Randomized Clinical Trial.

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 5, 2015
Registry last updated
Sep 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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