Post-operative Pain Relief in Laparoscopic Cholecystectomy
Primary Purpose
Postoperative Pain
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
bupivacaine
morphine
fentanyl
Ketamine:
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) classification I and II
- scheduled for elective laparoscopic cholecystectomy
- under a standardized general anesthesia technique.
Exclusion Criteria:
- uncooperative, unwilling,
- history of anaphylaxis to local anesthetics and/or opioids and the drugs to be used,
- history of drug abuse,
- anmorbidly obese patients,
- ASA classification III, IV, V
- d patients having any other significant co-morbidities
- any other with psychiatric disease
- pregnant women
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group A (placebo):
Group B
Group C
Group D
Arm Description
instillation of bupivacaine alone: Bupivacaine 25 ml (0.25%) after surgery completion
Instillation of bupivacaine and morphine: Bupivacaine 25 ml (0.25%) + Morphine (3.0 mg)
Instillation of bupivacaine and fentanyl: Bupivacaine25 ml (0.25%) + fentanyl (30.0 Mc)
Instillation of bupivacaine and Ketamine: Bupivacaine25 ml (0.25%) + ketamine (0.5 mg/kg).
Outcomes
Primary Outcome Measures
post operative pain
All subjects will be familiar with the visual analogue scale of pain (VAS) score preoperatively and will be instructed in detail on its use as a tool for measuring postoperative pain The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme .
A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm) .
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03355716
Brief Title
Post-operative Pain Relief in Laparoscopic Cholecystectomy
Official Title
Post-operative Pain Relief in Laparoscopic Cholecystectomy Using a Combination of Intraperitoneal Bupivacaine Morphine, Bupivacaine Fentanyl and Bupivacaine Ketamine: A Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2018 (Anticipated)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
March 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
compare the analgesic efficacy of the combination of bupivacaine and morphine, bupivacaine and fentanyl and bupivacaine and ketamine in alleviating post operative pain following laparoscopic cholecystectomy.
Detailed Description
Laparoscopic cholecystectomy is comparatively advantageous over open cholecystectomy in pain management with shorter duration of hospital stays. Pain management is medically pertinent for optimal care in surgical patients. Although development and advancement in understanding of the patho-physiology of pain, analgesics, pharmacology and the development of better effective techniques for post-operative pain control, patients still continue to experience considerable discomfort.
Laparotomy results in parietal pain, whereas laparoscopy has a visceral component, a somatic component and shoulder pain secondary to diaphragmatic irritation because of CO2 pneumo-peritoneum. Postoperative pain associated with laparoscopic cholecystectomy, although less severe and of shorter duration than that after open cholecystectomy, is still a source of marked discomfort and surgical stress. The degree of the pain after laparoscopic procedures has multifactorial influence including the volume of residual gas, type of gas used for pneumo-peritoneum, pressure created by the pneumo-peritoneum and insufflated gas temperature.
Local anesthetic infiltration of the incision sites decreases postoperative opiate requirement and improves subjective pain scores but does eliminate the pain.
Earlier scientists have also reported several beneficial effects of the intra-peritoneal application of bupivacaine with morphine on postoperative pain management after laparoscopic cholecystectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
At the end of the procedure, all the subjects will be randomly allocated to groups using computer-generated random numbers. Each group of 30 subjects, that is,
Group A (placebo):
instillation of bupivacaine alone: Bupivacaine 25 ml (0.25%) after surgery completion;
Group B :
Instillation of bupivacaine and morphine: Bupivacaine 25 ml (0.25%) + Morphine (3.0 mg)
Group C :
Instillation of bupivacaine and fentanyl: Bupivacaine25 ml (0.25%) + fentanyl (30.0 Mc)
Group D :
Instillation of bupivacaine and Ketamine: Bupivacaine25 ml (0.25%) + ketamine (0.5 mg/kg).
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A (placebo):
Arm Type
Placebo Comparator
Arm Description
instillation of bupivacaine alone: Bupivacaine 25 ml (0.25%) after surgery completion
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Instillation of bupivacaine and morphine: Bupivacaine 25 ml (0.25%) + Morphine (3.0 mg)
Arm Title
Group C
Arm Type
Active Comparator
Arm Description
Instillation of bupivacaine and fentanyl: Bupivacaine25 ml (0.25%) + fentanyl (30.0 Mc)
Arm Title
Group D
Arm Type
Active Comparator
Arm Description
Instillation of bupivacaine and Ketamine: Bupivacaine25 ml (0.25%) + ketamine (0.5 mg/kg).
Intervention Type
Drug
Intervention Name(s)
bupivacaine
Intervention Description
Bupivacaine 25 ml (0.25%)
Intervention Type
Drug
Intervention Name(s)
morphine
Intervention Description
Morphine (3.0 mg)
Intervention Type
Drug
Intervention Name(s)
fentanyl
Intervention Description
fentanyl (30.0 Mc)
Intervention Type
Drug
Intervention Name(s)
Ketamine:
Intervention Description
ketamine (0.5 mg/kg).
Primary Outcome Measure Information:
Title
post operative pain
Description
All subjects will be familiar with the visual analogue scale of pain (VAS) score preoperatively and will be instructed in detail on its use as a tool for measuring postoperative pain The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme .
A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm) .
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
American Society of Anesthesiologists (ASA) classification I and II
scheduled for elective laparoscopic cholecystectomy
under a standardized general anesthesia technique.
Exclusion Criteria:
uncooperative, unwilling,
history of anaphylaxis to local anesthetics and/or opioids and the drugs to be used,
history of drug abuse,
anmorbidly obese patients,
ASA classification III, IV, V
d patients having any other significant co-morbidities
any other with psychiatric disease
pregnant women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed Ahmed Mahmoud
Phone
0108834312
Email
dr_m_hamouda@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
abualauon Mohamed Abedalmohsen
Phone
01006253939
12. IPD Sharing Statement
Citations:
PubMed Identifier
26957685
Citation
Khurana S, Garg K, Grewal A, Kaul TK, Bose A. A comparative study on postoperative pain relief in laparoscopic cholecystectomy: Intraperitoneal bupivacaine versus combination of bupivacaine and buprenorphine. Anesth Essays Res. 2016 Jan-Apr;10(1):23-8. doi: 10.4103/0259-1162.164731.
Results Reference
background
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Post-operative Pain Relief in Laparoscopic Cholecystectomy
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