Evaluation of the effect of ketamine and bupivacaine combination on shoulder pain after gallbladder surgery by laparoscopy

Investigate the Effect of Interaperitoneal ketamin plus bupivacaine administration for pain relief laparascopic cholecystectomy and comparison with bupivacaine alon

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200513047418N1

Enrollment

Registered

2020-06-02

Start date

2019-07-01

Completion date

Unknown

Last updated

2020-06-15

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

Conditions

Shoulder pain after laparoscopic surgery. Pain, unspecified

Interventions

Intervention 1: Intervention group: In this group, 10 cc of bupivacaine 0.5% is combined with 0.5 mg / kg of ketamine, and with a normal saline of 0.9%, the volume of the drug reaches 20 cc.The compou

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: elective laparascopic cholecystectomy age 18 -65 year weight 55-100 kg The duration of surgery is less than two hours. No neurovascular disease, coagulation disorders, cardiovascular disease • No history of ketamine and bupivacaine allergy No history of abdominal surgery

Exclusion criteria

Exclusion criteria: use of alcohol, painkillers and anti-inflammatory and non-steroidal anti-inflammatory drugs Having chronic pain unrelated to gallbladder disease Dissatisfaction of the patient to continue participating in this study he need for laparotomy during laparoscopy having acute cholecystitis People who could not understand VAS.

Design outcomes

Primary

Measure	Time frame
The severity of shoulder pain after laparoscopic surgery on (Visual Analogue Scale). Timepoint: Two, four, six, eight hours after surgery. Method of measurement: Visual Analogue Scale(VAS).	—

Secondary

Measure	Time frame
Number of heartbeats. Timepoint: An hour before surgery and in 2-4-6-8 hours after surgery. Method of measurement: By counting the number of pulses per minute that is recorded in the checklist.;Dosage of analgesics. Timepoint: 8 hours after surgery. Method of measurement: Using a syringe, it is registered in the checklist in milligrams.;The first time analgesics are needed. Timepoint: 8 hours after surgery. Method of measurement: It is registered in the checklist and based on the minute.;Nausea and vomiting. Timepoint: 2-4-6-8 hours after surgery. Method of measurement: View and ask .By options has and does not have in the checklist.;Hypotension, pressure drop above 20% initial value. Timepoint: An hour before surgery and two, four, six, eight hours after laparoscopic cholecystectomy. Method of measurement: By a sphygmomanometer.	—

Measure

Time frame

Number of heartbeats. Timepoint: An hour before surgery and in 2-4-6-8 hours after surgery. Method of measurement: By counting the number of pulses per minute that is recorded in the checklist.;Dosage of analgesics. Timepoint: 8 hours after surgery. Method of measurement: Using a syringe, it is registered in the checklist in milligrams.;The first time analgesics are needed. Timepoint: 8 hours after surgery. Method of measurement: It is registered in the checklist and based on the minute.;Nausea and vomiting. Timepoint: 2-4-6-8 hours after surgery. Method of measurement: View and ask .By options has and does not have in the checklist.;Hypotension, pressure drop above 20% initial value. Timepoint: An hour before surgery and two, four, six, eight hours after laparoscopic cholecystectomy. Method of measurement: By a sphygmomanometer.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactParvin Ziaiei

Yazd University of Medical Sciences

p.ziaiei@ssu.ac.ir+98 31 3265 3741

Outcome results

None listed

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