Brief Summary

Colorectal cancer is the third most common cancer worldwide. These patients usually undergo open surgical resection of cancer under general anaesthesia. The aim of this study is to detect whether the Erector spinae plan block or Quadratus lumborum block will provide the most ideal analgesia for these patients. Erector spinae plan block is a novel analgesic technique that provides both visceral and somatic analgesia due to its communication with the paravertebral space. Quadratus lumborum block is a truncal nerve block usually used for intra-abdominal surgeries. Ultrasound guidance increases the accuracy and safety of both techniques. A local anaesthetic mixture of Bupivacaine 0.25% and dexamethasone will be used for both techniques.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline

Completed

Started May 2019

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

11 months study duration

First Submitted

Initial submission to the registry

January 3, 2019

Completed

11 days until next milestone

First Posted

Study publicly available on registry

January 14, 2019

Completed

4 months until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed

Last Updated

April 3, 2020

Status Verified

April 1, 2020

Enrollment Period

8 months

First QC Date

January 3, 2019

Last Update Submit

April 1, 2020

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

Postoperative pain score
The intensity of pain indicated by a segmented numeric scale in which a respondent selects a whole number (0-100 integers) that best reflects his/her pain as 0-30 for mild pain, 30-60 for moderate pain and 60-100 for sever pain
From 1 day before the surgery to the 2 days after surgery

Secondary Outcomes (9)

Systolic Blood Pressure
One hour before induction of general anesthesia, every 10 minutes till end of surgery, every 4 hours till end of the first 24 hours postoperatively, then every 8 hours till end of the next 24 hours
Mean Blood Pressure
One hour before induction of general anesthesia, every 10 minutes till end of surgery, every 4 hours till end of the first 24 hours postoperatively, then every 8 hours till end of the next 24 hours
Heart rate
One hour before induction of general anesthesia, every 10 minutes till end of surgery, every 4 hours till end of the first 24 hours postoperatively, then every 8 hours till end of the next 24 hours
Time to first rescue analgesic request
Up to 48 postoperative hours
Peripheral oxygen saturation
One hour before induction of general anesthesia, every 10 minutes till end of surgery, every 4 hours till end of the first 24 hours postoperatively, then every 8 hours till end of the next 24 hours
+4 more secondary outcomes

Study Arms (2)

Erector spinae plane block

ACTIVE COMPARATOR

Patients will receive bilateral ultrasound-guided erector spinae plane block as an adjuvant analgesic technique

Other: Erector spinae plane blockDrug: PropofolDrug: Fentanyl NCSDrug: Atracurium Injectable ProductOther: Endotracheal intubationDrug: Anesthesia MaintenanceDrug: Muscle Relaxation

Quadratus lumborum block

ACTIVE COMPARATOR

Patients will receive bilateral ultrasound-guided quadratus lumborum block as an adjuvant analgesic technique

Other: Quadratus lumborum blockDrug: PropofolDrug: Fentanyl NCSDrug: Atracurium Injectable ProductOther: Endotracheal intubationDrug: Anesthesia MaintenanceDrug: Muscle Relaxation

Interventions

Erector spinae plane blockOTHER

For each side, the eighth thoracic transverse process will be identified by a linear US transducer (HFL38\_10-5 MHz), puncture will be performed in the plane in the craniocaudal direction until the needle contacts the transverse process, and 20 ml of bupivacaine 0.25% and 4 mg dexamethasone will be injected visualizing the hydrodissection. After 30 minutes, the degree of sensory block in the trunk will be assessed by the pinprick test and any undesirable motor weakness will be recorded as a side effect.

Erector spinae plane block

Quadratus lumborum blockOTHER

For each side, shamrock sign with three leaves (psoas major muscle anteriorly, the erector spinae muscle posteriorly and the quadratus lumborum muscle adherent to the apex of the transverse process of the L4 vertebral body) will be identified by a curved array US transducer (6-2MHz), puncture will be performed in-plane, the needle will be advanced through the quadratus lumborum muscle penetrating the ventral proper fascia of the quadratus lumborum muscle, and 20 mL of bupivacaine 0.25% and 4 mg dexamethasone will be injected in that space visualizing the hydrodissection. After 30 minutes, the degree of sensory block in the trunk will be assessed by the pinprick test and any undesired motor weakness will be recorded as a side effect

Quadratus lumborum block

PropofolDRUG

Propofol (2 mg/kg)