Post-operative Pain Relief in Laparoscopic Cholecystectomy
NCT ID: NCT03355716
Last Updated: 2017-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2018-01-31
2019-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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).
TREATMENT
TRIPLE
Study Groups
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Group A (placebo):
instillation of bupivacaine alone: Bupivacaine 25 ml (0.25%) after surgery completion
bupivacaine
Bupivacaine 25 ml (0.25%)
Group B
Instillation of bupivacaine and morphine: Bupivacaine 25 ml (0.25%) + Morphine (3.0 mg)
bupivacaine
Bupivacaine 25 ml (0.25%)
morphine
Morphine (3.0 mg)
Group C
Instillation of bupivacaine and fentanyl: Bupivacaine25 ml (0.25%) + fentanyl (30.0 Mc)
bupivacaine
Bupivacaine 25 ml (0.25%)
fentanyl
fentanyl (30.0 Mc)
Group D
Instillation of bupivacaine and Ketamine: Bupivacaine25 ml (0.25%) + ketamine (0.5 mg/kg).
bupivacaine
Bupivacaine 25 ml (0.25%)
Ketamine:
ketamine (0.5 mg/kg).
Interventions
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bupivacaine
Bupivacaine 25 ml (0.25%)
morphine
Morphine (3.0 mg)
fentanyl
fentanyl (30.0 Mc)
Ketamine:
ketamine (0.5 mg/kg).
Eligibility Criteria
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Inclusion Criteria
* scheduled for elective laparoscopic cholecystectomy
* under a standardized general anesthesia technique.
Exclusion Criteria
* 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
22 Years
60 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Mohammed Ahmed Mahmoud
Principal investigator
Central Contacts
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abualauon Mohamed Abedalmohsen
Role: CONTACT
Phone: 01006253939
References
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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.
Other Identifiers
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post-oprative pain relief
Identifier Type: -
Identifier Source: org_study_id