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Effect of devil's claw plant on shoulder pain in laparoscopic gallbladder surgery

The effect of Harpagophytum capsule on shoulder pain, nausea and vomiting and hemodynamic in patient undergoing laparoscopic cholecystectomy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230226057543N1
Enrollment
64
Registered
2023-06-23
Start date
2023-08-23
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Shoulder pain after laparoscopic cholecystectomy. Pain, not elsewhere classified

Interventions

Intervention 1: Intervention group: 32 people are randomly assigned to the intervention group. who are given capsules containing Harpagaphytum. Harpagaphytum 480 mg coated tablet called Talental from

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: patient undergoing laparoscopic cholecystectomy Patient's consent to participate in the intervention and written consent Full consciousness of the patient I and II in ASA category Understanding the Persian language

Exclusion criteria

Exclusion criteria: psychiatric illness history of acute and chronic nausea and vomiting (such as gastrointestinal and ear disorders) drug and alcohol addiction Allergy to sesame pregnancy and breastfeeding history of abdominal surgery

Design outcomes

Primary

MeasureTime frame
Visual Analogue Scale pain score of Right Shoulder. Timepoint: Patients are given one capsule the night before surgery. Subsequent doses are given every 12 hours for up to 48 hours. The time periods of measuring shoulder pain are at 0 hours (immediately after surgery) and 2, 6, 12, 24 and 48 hours after that. Method of measurement: Visual Analogue Scale.;Visual Analogue Scale pain score of left shoulder. Timepoint: Patients are given one capsule the night before surgery. Subsequent doses are given every 12 hours for up to 48 hours. The time periods of measuring shoulder pain are at 0 hours (immediately after surgery) and 2, 6, 12, 24 and 48 hours after that. Method of measurement: Visual Analogue Scale.

Secondary

MeasureTime frame
Systolic blood pressure. Timepoint: Before induction of anesthesia, 5 minutes after insufflation of carbon dioxide gas, end of surgery. Method of measurement: Patient monitoring system.;Diastolic blood pressure. Timepoint: Before induction of anesthesia, 5 minutes after insufflation of carbon dioxide gas, end of surgery. Method of measurement: Patient monitoring system.;Heart rate. Timepoint: Before induction of anesthesia, 5 minutes after insufflation of carbon dioxide gas, end of surgery. Method of measurement: Patient monitoring system.;Respiratory rate. Timepoint: Before induction of anesthesia, 5 minutes after insufflation of carbon dioxide gas, end of surgery. Method of measurement: Patient monitoring system.;Arterial o2 saturation. Timepoint: Before induction of anesthesia, 5 minutes after insufflation of carbon dioxide gas, end of surgery. Method of measurement: Patient monitoring system.;Vomiting frequency. Timepoint: The number of times the patient vomits in 48 hours after surgery (when the intervention is finished) is recorded. Method of measurement: Frequency (asking the patient).;Nausea. Timepoint: Patients are given one capsule the night before surgery. Subsequent doses are given every 12 hours for up to 48 hours. The time periods for measuring nausea are at 0 hours (immediately after surgery) and 2, 6, 12, 24 and 48 hours after that. Method of measurement: Visual Analogue Scale.;Stomach ache. Timepoint: Patients are given one capsule the night before surgery. Subsequent doses are given every 12 hours for up to 48 hours. Abdominal pain measurement time points are 0 hours (immediately after surgery) and 2, 6, 12, 24 and 48 hours after that. Method of measurement: Visual Analogue Scale.;Ports area pain. Timepoint: Patients are given one capsule the night before surgery. Subsequent doses are given every 12 hours for up to 48 hours. The time points for measuring the pain of the ports are at 0 hours (immediately after surgery) and 2, 6, 12, 24 and 48 hours

Countries

Iran (Islamic Republic of)

Contacts

Public ContactEbrahim Nasiri Formi

Mazandaran University of Medical Sciences

enasiri@mazums.ac.ir+98 11 3354 3247

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026