Dose and Concentration Relationship for PENG Block in Hip Surgery

Dose and Concentration Relationship of Bupivacaine for Pericapsular Nerve Group Block in Hip Surgery

A number of peripheral nerve blocks are routinely performed in patients who will undergo orthopedic hip surgery for pain relief. Proximal extensor group nerve (PENG) block is one such field block which is used for this purpose and could be performed both before and after the operation. When used before surgery, PENG block is reported to be beneficial in alleviating pain during positioning for spinal anesthesia. Furthermore, some studies suggest a high volume block may increase the analgesic effect of the block. In this perspective, this study aims to observe the effects of different volumes of local anesthetic (bupivacaine) at the same dose used for PENG block in hip fracture positioning for spinal anesthesia.

The investigator hypothesizes that a high volume (>20ml) PENG block will reduce pain during positioning compared to a low volume PENG block.

Study Overview

• Status: Completed
• Conditions: Hip Fractures; Post Operative Pain
• Intervention / Treatment: Drug: Bupivacaine Hydrochloride

Detailed Description

This prospective observational study will be conducted between 04.07.2022-04.01.2023 in the orthopedic operating rooms of T.C. Ministry of Health University of Health Sciences Prof. Dr. Cemil Taşçıoğlu City Hospital. Patients over the age of 18 who are scheduled for hip fracture under spinal anesthesia meeting the inclusion criteria and who agree to participate in the study by signing a consent form will be included. Patients will be surveyed about the amount of pain they suffer with numerical rating scale (NRS) four times; firstly, 15 minutes after the block at rest, then, a second time with a 10 degree hip flexion, after that a third time when patient is given sitting position for spinal anesthesia, and lastly, 24 hours after the surgery. Age, height, weight, gender, co-morbidities, American Society of Anesthesiologists physical condition (ASA) scores, time of block administration, whether an intraoperative complication developed (hypotension, tachycardia, bradycardia, inotropic need, desaturation), local anesthetic (bupivacaine) volume used for PENG block will be recorded from the anesthesia charts. Twenty-four hours after the surgery patients will be questioned for nausea, vomiting and urinary retention. At this point the 4 A's test (4AT) will be performed to detect any presence of delirium. Postoperative iv analgesic treatments and mobilization times(if mobilized) of the patients will be recorded from patient charts. Resulting data for low volume (less than or equal to 20ml) and high volume PENG blocks will be compared.

It is expected that a total of 112 patients will be recruited for this study. A power analysis revealed that it is necessary to recruit at least 102 patients, when effect size d is assumed to be 0.5 ( for medium difference) for a 0.05 alpha error with a %80 power. Taking in account a 10% follow-up loss we planned to recruit 112 patients.

• Study Type: Observational
• Enrollment (Actual): 112

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34384
    • Prof. Dr. Cemil Tascioglu City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients will be selected consecutively from those who are admitted to a tertiary care center with a diagnosis of hip fracture and scheduled for a hip surgery in a tertiary care center, until the required sample size is achieved.

Description

Inclusion Criteria:

• Patients over the age of 18 who consent to participate and;
• Patients who are scheduled for hip surgery under spinal anaesthesia,
• Patients who have no neurocognitive disorders that impair cooperation and communication (e.g Alzheimer's disease, Parkinson's disease, senile dementia),
• Patients who have no local anaesthetic allergies,
• Patients to whom an analgesic PENG block was administered preoperatively to facilitate sitting position during spinal anaesthesia will be included.

Exclusion Criteria:

• Patients under the age of 18,
• Patients who decline to participate,
• Patients who are scheduled for hip surgery under general anaesthesia
• Patients who have neurocognitive disorders
• Patients who have local anaesthetic allergies
• Patients to whom an analgesic PENG block was NOT administered preoperatively to facilitate sitting position during spinal anaesthesia will be excluded.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
low volume; This cohort will include the patients to whom an analgesic PENG block was administered with a bupivacaine solution volume of up to 20 ml in a dose of 2.5mg/kg-1. This cohort is anticipated to have 56 participants.	Drug: Bupivacaine Hydrochloride; Patients who were administered an analgesic PENG block with a dose of 2.5mg/kg with either lov (<20ml) or high volume (>20ml); Other Names: PENG block
high volume; This cohort will include the patients to whom an analgesic PENG block was administered with a bupivacaine solution volume more than 20 ml in a dose of 2.5mg/kg-1. This cohort is anticipated to have 56 participants.	Drug: Bupivacaine Hydrochloride; Patients who were administered an analgesic PENG block with a dose of 2.5mg/kg with either lov (<20ml) or high volume (>20ml); Other Names: PENG block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sitting pain	Pain score according to numerical rating scale when patient is brought to sitting position for spinal anesthesia. Numeric rating scale is a patient's self reported pain score between a minimum of "0" and a maximum of "10". Higher numbers indicate worse pain. A score of "0" means that patient suffers no pain at all while a score of "10" means they suffer the worst pain possible.	30 minutes after PENG block is performed

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Block pain at rest	Pain score at rest according to numerical rating scale after PENG blok is performed. Numeric rating scale is a patient's self reported pain score between a minimum of "0" and a maximum of "10". Higher numbers indicate worse pain. A score of "0" means that patient suffers no pain at all while a score of "10" means they suffer the worst pain possible.	15 minutes after PENG block is performed
Block pain with movement	Pain score with 10 degree flexion according to numerical rating scale after PENG. Numeric rating scale is a patient's self reported pain score between a minimum of "0" and a maximum of "10". Higher numbers indicate worse pain. A score of "0" means that patient suffers no pain at all while a score of "10" means they suffer the worst pain possible.	15 minutes after PENG block is performed
Postoperative pain	Pain score at rest according to numerical rating scale postoperatively. Numeric rating scale is a patient's self reported pain score between a minimum of "0" and a maximum of "10". Numbers increase with increasing pain and a score of "0" means that patient suffers no pain at all and "10" means they suffer the worst pain possible.	Postoperative 24th hour
Breakthrough analgesic use	Existence and amount of breakthrough analgesics used	Postoperative 24th hour
Delirium	Existence of delirium according to 4AT score	Postoperative 24th hour

Collaborators and Investigators

• Sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
• Investigators: Principal Investigator: Onur OKUR, Prof. Dr. Cemil Taşcıoğlu City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): May 5, 2023

Study Registration Dates

• First Submitted: May 27, 2022
• First Submitted That Met QC Criteria: May 27, 2022
• First Posted (Actual): June 1, 2022

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: postoperative pain; hip fracture; peripheral nerve blocks; bupivacaine volume
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Pain, Postoperative; Hip Fractures; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 108

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No