Surgicel and Analgesic Reservoir

NCT03730714 | Completed Phase 2 DMC

• 1 other identifier: Surgicel
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Laparoscopic cholecystectomy (LC) is a widespread surgical procedure with superior outcomes in terms of the incurred postoperative pain, recovery time, cosmetic, and morbidity issues. Although it is associated with less postoperative pain compared to open cholecystectomy, but patients still experience significant pain. Pain after LC is categorized into three types: referred pain to the right shoulder due to diaphragmatic stretching during gas insufflation; visceral pain due to dissection and injury at the hepatic fossa during gall bladder removal; and somatic pain due to tissue injury at the port sites. Since the discovery of LC in 1987 by a French surgeon, Phillipe Mouret, it became the gold standard for surgical excision of the gallbladder. Local anesthetics (LA) has been tried for analgesia after LC in variable techniques and concentrations. It was proved to be a safe and valid method for reducing pain after LC instilled intraperitoneal and infiltrated at the port sites. Surgicel is an absorbable gelatin sponge that is non-toxic, non-allergenic, non-immunogenic, and non-pyrogenic. It is gamma-sterilized and provided with double packing. The sponge is easily cut to fit the surgical cavity. It may be applied dry to the wound. It absorbs 40 times its weight of whole blood or 50 times of water and adheres easily to the bleeding site. It forms a stable adherent coagulum. When implanted in vivo, it is completely absorbed within 3-5 weeks. The rationale for using this sponge as interposition material is to act as a carrier for the analgesic drugs and allow for its local sustained release, and for local hemostasis. Bupivacaine will be used as the main local anesthetic medication in the study. It provides variable pain relief when either used to irrigate intraperitoneal space as a sole analgesic or combined with opioids. Lidocaine 2% will be mixed with bupivacaine to expedite the onset of analgesia. Epinephrine will be used as 5 microgram/ml of the total mixture of used fluids in order to prolong the time of action of the block.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Visual Analouge Scale

  Postoperative abdominal and shoulder pain using 0-10 scale (with 0 indicating no pain and 10 as the most severe pain ever experienced)

  24 hours

Secondary Outcomes (3)

• Peak expiratory flow rate

  60 minutes

• Postoperative Complications

  24 hours

• 5-point Likert scale

  24 hours

Study Arms (3)

Ggroup LAM

ACTIVE COMPARATOR

Patients will receive local anesthesia Bupivacaine 0.5% 20 ml (no more than 2 mg/kg) plus lidocaine 2% 10 ml (no more than 3 mg/kg) mixed together, plus epinephrine 5 mcg/ml (max 150 mcg), combined with morphine 0.1 mg/kg (max10 mg) instilled into the assigned areas according to the technique.

Drug: "Local Anesthetic", "Epinephrine" and "Morphine"

Ggroup LAMG

ACTIVE COMPARATOR

Patients will receive the same mixture in LAM-group to soak the surgicel according to the previous planned technique.

Drug: "Local Anesthetic", "Epinephrine", "Morphine" and "Surgicel"

Group CG

ACTIVE COMPARATOR

Patients will receive normal saline 0.9% to soak the surgicel according to the planned technique.

Drug: "Normal Saline"

Interventions

"Local Anesthetic", "Epinephrine" and "Morphine" DRUG

local anesthesia Bupivacaine 0.5% 20 ml (no more than 2 mg/kg) plus lidocaine 2% 10 ml (no more than 3 mg/kg) mixed together, plus epinephrine 5 mcg/ml (max 150 mcg), combined with morphine 0.1 mg/kg (max10 mg)

Ggroup LAM

"Local Anesthetic", "Epinephrine", "Morphine" and "Surgicel" DRUG

Surgicel soaked with mixture of: local anesthesia Bupivacaine 0.5% 20 ml (no more than 2 mg/kg) plus lidocaine 2% 10 ml (no more than 3 mg/kg) mixed together, plus epinephrine 5 mcg/ml (max 150 mcg), combined with morphine 0.1 mg/kg (max10 mg)

Ggroup LAMG

"Normal Saline" DRUG

normal saline 0.9% to soak the surgicel according to the planned technique

Group CG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years old patients from both genders scheduled for laparoscopic cholecystectomy
• Clinical and laboratory multisystem preoperative evaluation prove a health status of American society of Anesthesiology grade I/II
• Absence of current active inflammatory medical condition

You may not qualify if:

• Allergic reaction to the study medicine
• Patients' health status beyond the specified range
• Patients with seizure diseases
• Patients with significant chronic respiratory disease
• Patients with intraperitoneal infection

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospitals

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthetics, Local; Epinephrine; Morphine; Surgicel; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; 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; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Esam A. Hamed, M.D.

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia and Intensive Care

Study Record Dates

• First Submitted: November 2, 2018
• First Posted: November 5, 2018
• Study Start: November 15, 2018
• Primary Completion: August 12, 2020
• Study Completion: August 12, 2020
• Last Updated: August 18, 2020

Record last verified: 2020-08

Locations

EG (1)