Post-operative Pain Relief in Laparoscopic Cholecystectomy

NCT03355716 | Unknown

• 1 other identifier: post-oprative pain relief
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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) .

  24 hours

Study Arms (4)

Group A (placebo):

PLACEBO COMPARATOR

instillation of bupivacaine alone: Bupivacaine 25 ml (0.25%) after surgery completion

Drug: bupivacaine

Group B

ACTIVE COMPARATOR

Instillation of bupivacaine and morphine: Bupivacaine 25 ml (0.25%) + Morphine (3.0 mg)

Drug: bupivacaine; Drug: morphine

Group C

ACTIVE COMPARATOR

Instillation of bupivacaine and fentanyl: Bupivacaine25 ml (0.25%) + fentanyl (30.0 Mc)

Drug: bupivacaine; Drug: fentanyl

Group D

ACTIVE COMPARATOR

Instillation of bupivacaine and Ketamine: Bupivacaine25 ml (0.25%) + ketamine (0.5 mg/kg).

Drug: bupivacaine; Drug: Ketamine:

Interventions

bupivacaine DRUG

Bupivacaine 25 ml (0.25%)

Group A (placebo):; Group B; Group C; Group D

morphine DRUG

Morphine (3.0 mg)

Group B

fentanyl DRUG

fentanyl (30.0 Mc)

Group C

Ketamine: DRUG

ketamine (0.5 mg/kg).

Group D

Eligibility Criteria

• Age: 22 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists (ASA) classification I and II
• scheduled for elective laparoscopic cholecystectomy
• under a standardized general anesthesia technique.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• 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.

  PMID: 26957685 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Morphine; Fentanyl; Ketamine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Mohammed Ahmed Mahmoud

CONTACT

0108834312; dr_m_hamouda@yahoo.com

abualauon Mohamed Abedalmohsen

CONTACT

01006253939

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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).

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: November 28, 2017
• Study Start: January 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: March 1, 2019
• Last Updated: November 28, 2017

Record last verified: 2017-11