Surgicel and Analgesic Reservoir

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

Interventions

DRUG

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

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)

DRUG

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

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)

DRUG

"Normal Saline"

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

Sponsors & Collaborators

• Assiut University

  lead OTHER

Principal Investigators

• Esam A. Hamed, M.D. · Assiut University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-11-15

Primary Completion

2020-08-12

Completion

2020-08-12

Countries

• Egypt

Study Locations