Find the Adequate Dose of Nalbuphine for Laparoscopic Cholecystectomy

Post Operative Pain Clinical Trial

Official title:

Find the Adequate Dose of Nalbuphine for Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04135534
• Other study ID #: KMUHIRB-F(I)-20190070
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: October 2019
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: Guan-Yu Chen, MD
• Phone: 88673121101
• Email: kindtaco[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluate the adequate dose of mutonpain for laparoscopic cholecystectomy in the management of post operative pain. The investigators will randomize patients into three groups to compare the analgesia effects and side effects.

Description:

Nalbuphine is a FDA approved noncontrolled drug of opioid. And it had been applied for post operative pain for different surgeries, claiming that less nausea and vomiting with the same analgesic effect when comparing with morphine.

However, several studies concerning post pain management usually used nalbuphine 0.15-0.3 mg/kg for laparoscopic cholecystectomy. If the analgesic effect of nalbuphine is similar with morphine, less nalbuphine injection could reduce the side effects of opioid.

The investigators will randomize patients into three groups of different initial nalbuphine dose for post laparoscopic cholecystectomy surgical pain, and set patient control analgesia machine with nalbuphine for further pain management. If the pain or side effects of opioid were intolerable, the investigators will change pain medications into NSAIDs or other adequate medications to comfort the patient.

The primary outcome were numerical rating pain score and consumption of nalbuphine. The secondary outcomes were nausea, vomiting, pruritus and satisfactory score, and if any other medications use.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 1, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• patient accept laparoscopic cholecystectomy

• age:20-80 years old

Exclusion Criteria:

• nalbuphine allergy

• chronic pain

• active liver disease that would affect metabolization of nalbuphine

• patient who had regular pain medications

• patient who could not cooperate to the evaluation of the survey

• dementia or other psychiatric disease

Related Conditions & MeSH terms

• Opioid Side Effects
• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• group A
mutonpain 0.05 mg/kg
• group B
mutonpain 0.1 mg/kg
• group C
mutonpain 0.2 mg/kg

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	use of antiemetics	if the patient use of antiemetics during the hospitalization	2 days
Other	use of antipruritics	if the patient use of antipruritics during the hospitalization	2 days
Primary	Numerical Rating Pain Scale	The Numerical Pain Rating Scale is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain). The investors will measure the pain score at rest state and upon movement state at post-operative 1 hour, 2 hours, 4 hours, 24 hours, 36 hours.	numerical rating pain scale change at post-operative 1 hour, 2 hours, 4 hours, 24 hours, 36 hours
Primary	consumption of nalbuphine	The investors will use patient control analgesia machine to calculate the time dependent dose of nalbuphine.	Record the opioid dose changes 2 days.
Secondary	nausea	we will go to bed side and have an self-report episode of nausea at 1 hour, 2 hours, 4 hours, 24 hours, 36 hours post operation	the nausea sensation changes at post operation 1 hour, 2 hours, 4 hours, 24 hours, 36 hours
Secondary	vomiting	we will go to bed side and have an self-report episode of vomiting at 1 hour, 2 hours, 4 hours, 24 hours, 36 hours post operation	the vomiting episodes at post operation 1 hour, 2 hours, 4 hours, 24 hours, 36 hours
Secondary	satisfactory score by net promoter score	The net promoter score is a subjective measure in which individuals rate their satisfactory on an ten-point numerical scale. The scale is composed of 1 to 10. We will measure the net promoter score at the end of the study	2 days
Secondary	use of rescue pain medications	if the patient use other pain medication on request of poor pain control or poor tolerant of the side effects of nalbuphine	record if any rescue pain medications at post operation 1 hour, 2 hours, 4 hours, 24 hours, 36 hours