Preemptive Ketorolac for Shoulder Tip Pain During Cesarean Section

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.

Study Overview

• Status: Completed
• Conditions: Cesarean Section
• Intervention / Treatment: Drug: Ketorolac; Drug: Normal saline

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 11111
    • Assiut University hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Intraoperative shoulder tip pain	intraoperative

Secondary Outcome Measures

Outcome Measure	Time Frame
pain score VAS	intraoperative

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: March 1, 2015
• First Submitted That Met QC Criteria: March 4, 2015
• First Posted (Estimate): March 5, 2015

Study Record Updates

• Last Update Posted (Actual): September 14, 2017
• Last Update Submitted That Met QC Criteria: September 12, 2017
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ketorolac
• Other Study ID Numbers: Ketorolac