Post-operative Pain Relief in Laparoscopic Cholecystectomy

Assiut University

Status: Unknown

Conditions: Postoperative Pain

Treatments: Drug: morphine; Drug: fentanyl; Drug: Ketamine:; Drug: bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03355716

post-oprative pain relief

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 22 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 4 patient groups, including a placebo group

Group A (placebo):

Placebo Comparator group

Description:

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

Treatment:

Drug: bupivacaine

Group B

Active Comparator group

Description:

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

Treatment:

Drug: morphine

Drug: bupivacaine

Group C

Active Comparator group

Description:

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

Treatment:

Drug: bupivacaine

Drug: fentanyl

Group D

Active Comparator group

Description:

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

Treatment:

Drug: Ketamine:

Drug: bupivacaine