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Postoperative pain after open cholecystectomy

Postoperative pain in diabetic patients following open cholecystectomy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12618000643279
Enrollment
70
Registered
2018-04-23
Start date
2016-06-30
Completion date
2018-02-28
Last updated
2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Pre-clinical studies have shown that experimental diabetes induces hyperalgesia in rodents. Additionally, diabetic patients report more postoperative pain after lumbar spine surgery or total abdominal hysterectomy than non-diabetic patients. Interestingly, some studies indicate that cholelithiasis is three times more frequent in diabetic than in non-diabetics patients. However, the comparison of postoperative pain after cholecystectomy between diabetic and non-diabetic patients remains unknown. Thus, the primary aim was evaluate the intensity of postoperative acute pain in diabetic patients undergoing open cholecystectomy.

Interventions

Patients without or with type 2 diabetes diagnosed with chronic cholecystitis and scheduled for elective open cholecystectomy will be studied. All patients will receive a general anaesthetic and maintained with sevoflurane 1.5% and fentanyl 5 µg/kg. Patients also receive diclofenac 75 mg i.v. once before the surgical incision. Haemodynamic variables were defined as: hypotension (MAP < 60 mmHg), hypertension (MAP > 100 mmHg), bradycardia (heart rate < 40 beats/min) and tachycardia (heart rate >

Patients without or with type 2 diabetes diagnosed with chronic cholecystitis and scheduled for elective open cholecystectomy will be studied. All patients will receive a general anaesthetic and maintained with sevoflurane 1.5% and fentanyl 5 µg/kg. Patients also receive diclofenac 75 mg i.v. once before the surgical incision. Haemodynamic variables were defined as: hypotension (MAP < 60 mmHg), hypertension (MAP > 100 mmHg), bradycardia (heart rate < 40 beats/min) and tachycardia (heart rate > 90 beats/min). After completion of the surgical procedure (final suture) and emergence from anaesthesia, all patients will be transferred to the recovery room. Duration of surgery was defined as the time from skin incision to completion of skin suturing. Onset of postoperative pain was defined as the time from end of anaesthesia until presence of any postoperative pain score. Pain management will be immediately after assessment according to institutional standards. Postoperative pain will be evaluated by using a 0–10 numerical rating scale (NRS) (0 = no pain and 10 = worst pain imaginable), and onset of postoperative pain will be defined as the time from end of anaesthesia until presence of any postoperative pain score. Each participants will be observed for at least 8 hours post-surgery,

Sponsors

Hospital Regional de Alta Especialidad “Dr. Juan Graham Casasús”
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

Patients diagnosed with chronic cholecystitis and scheduled for elective open cholecystectomy. Age > 18yr Weight > 40 kg American Society of Anesthesiology physical status (ASA) I, II or III.

Exclusion criteria

Allergy to non-steroidal anti-inflammatory drugs or diclofenac History of peptic ulcer disease Haemorrhagic diathesis, coronary heart disease Bronchial asthma Seizure disorders, pregnancy or any others contraindications

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026