Gall Bladder Bed Infiltration Analgesia

NCT03693820 | Completed

• 1 other identifier: MS.18.09.277
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Early postoperative pain is a common complaint after elective laparoscopic cholecystectomy. Persistent acute postoperative pain is the dominating complaint and the primary reason for a prolonged stay after this procedure. This pain can be superficial incisional wound pain (somatic), deep visceral pain and/or post-laparoscopy shoulder pain (referred somatic), all of which may require systemic analgesia. Hypothesis: Laparoscopic pain can be superficial incisional wound pain (somatic pain), deep visceral pain and/or post-laparoscopy shoulder pain (referred somatic pain), so the block must be periportal for incisional wound pain, intraperitoneal to decrease pain caused by pneumoperitoneum, and of the bladder bed to decrease the deep visceral pain. This combination can give the maximum analgesia after laparoscopic cholecystectomy.

Conditions

Pain, Acute

Keywords

cholecystectomy;; analgesia;; gallbladder;; infiltration;; visceral pain

Outcome Measures

Primary Outcomes (1)

• The total postoperative analgesic consumption

  ketorolac and morphine in mg .

  postoperative, for 24 hours

Secondary Outcomes (9)

• The time to the first request of analgesia

  postoperative, for 24 hours

• The intraoperative fentanyl requirements.

  intraoperative

• postoperative pain score: VAS

  postoperative at 0, 2, 4, 8, 12, 16 and 24 hours

• heart rate

  basal and intraoperatively every 30 minutes, then at 0, 2, 4, 8, 12, 16 and 24 hours post-operatively.

• mean blood pressure

  basal and intraoperatively every 30 minutes, then at 0, 2, 4, 8, 12, 16 and 24 hours post-operatively.

Study Arms (2)

the infiltration group

ACTIVE COMPARATOR

a cocktail of 5 mg/Kg lidocaine normal saline in a volume of 3 ml/Kg 5 mcg/ml adrenaline. We will administrate 5 ml lidocaine at each port site before incision, then immediately after the creation of the pneumoperitoneum, the surgeon will spray 50-75 ml of the total solution on the upper surface of the liver under the right sub-diaphragmatic space and another 50-75ml over the parietal peritoneum. The Trendelenburg position will be maintained for 2 minutes. Then 50 ml will be infiltrated in the bladder bed and pedicle after clamping of the cystic duct and artery. Infiltration will be through a laparoscopic suction needle, diameter 0.9 /330 mm (Zhejiang, China).

Drug: the infiltration group

the control group

PLACEBO COMPARATOR

the same technique but the 50 ml for gallbladder infiltration will be replaced by saline.

Drug: the control group

Interventions

the infiltration group DRUG

* 15-20 ml periportal, * 50 ml in gallbladder bed, * The rest (about 150 ml in 70 Kg patient) will be intraperitoneal

the infiltration group

the control group DRUG

the 50 ml prepared for gallbladder bed infiltration will be replaced by saline.

the control group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Scheduled to undergo elective laparoscopic cholecystectomy.
• American Society of Anesthesiologists physical status (ASA) I or II.

You may not qualify if:

• Patient in receipt of analgesics or sedatives 24 h before scheduled surgery.
• Patient with spillage or cholelithiasis with known common bile duct pathology.
• Body Mass Index \> 40 Kg/m2.
• Patient underlying severe systemic disease.
• Patient with a history of abdominal surgery, a chronic pain disorder other than gallbladder disease or allergy to lidocaine.

Sponsors & Collaborators

• Alaa Mazy Mazy: lead

Study Sites (1)

Gastro-enterolgy surgical center, Mansoura University

Al Mansurah, Al-Dakahleia, 35516, Egypt

Location

MeSH Terms

Conditions

Acute Pain; Agnosia; Visceral Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Nociceptive Pain

Study Officials

• alaa mazy, MD

  faculty of medicine, Mansoura

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: the infiltration cocktail of local anesthetic will be replaced by saline in the same volume.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate prosseor

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 3, 2018
• Study Start: September 10, 2018
• Primary Completion: June 1, 2019
• Study Completion: July 11, 2019
• Last Updated: September 18, 2020

Record last verified: 2018-10

Locations

EG (1)