Post-operative Pain Relief in Laparoscopic Cholecystectomy

Postoperative Pain Clinical Trial

Official title:

Post-operative Pain Relief in Laparoscopic Cholecystectomy Using a Combination of Intraperitoneal Bupivacaine Morphine, Bupivacaine Fentanyl and Bupivacaine Ketamine: A Comparative Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03355716
• Other study ID #: post-oprative pain relief
• Status: Not yet recruiting
• Phase: N/A
• First received: November 21, 2017
• Last updated: November 27, 2017
• Start date: January 2018
• Est. completion date: March 2019

Study information

• Verified date: November 2017
• Source: Assiut University
• Contact: Mohammed Ahmed Mahmoud
• Phone: 0108834312
• Email: dr_m_hamouda[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: March 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• bupivacaine
Bupivacaine 25 ml (0.25%)
• morphine
Morphine (3.0 mg)
• fentanyl
fentanyl (30.0 Mc)
• Ketamine:
ketamine (0.5 mg/kg).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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