The Quality of Recovery After Intrathecal Morphine or Adductor Canal Block in Anterior Cruciate Ligament Reconstruction

The Quality of Recovery After Intrathecal Morphine or Adductor Canal Block Added to Spinal Anesthesia in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Reconstruction

The Quality of Recovery 40 (QoR-40) is a multidimensional questionnaire that addresses many aspects of postoperative recovery. The QoR-40 has been used many times to measure the recovery of patients after different surgeries, and this questionnaire seems to be a reliable tool for evaluating anesthesia-related techniques, including regional anesthesia. Arthroscopic knee surgery causes moderate to severe postoperative pain for most patients. Various methods such as different systemic drugs, peripheral or central blocks and intra-articular injections have been developed for the effective, safe and long-term control of this pain. In recent years, it has been shown that regional anesthesia techniques reduce the need for opioids in orthopedic ambulatory surgeries and accelerate recovery and discharge. However, there is no consensus on which is the best approach among these various regional techniques. However, adductor canal block (ACB) and intrathecal morphine (ITM) are the preferred regional methods in the perioperative pain management of knee surgery. In this study, it was aimed to test the effectiveness of intrathecal morphine or adductor canal block added to spinal anesthesia on the quality of recovery in patients undergoing arthroscopic anterior cruciate ligament reconstruction surgery.

Study Overview

• Status: Recruiting
• Conditions: Quality of Recovery; Adductor Canal Block; Intrathecal Morphine; Arthroscopic Anterior Cruciate Ligament Reconstruction
• Intervention / Treatment: Drug: Intrathecal morphine; Drug: Adductor canal block

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Saricam
    • Adana, Saricam, Turkey, 01330
      • Recruiting
      • Çukurova University
      • Contact: Demet Laflı Tunay, MD; Phone Number: +905358685831; Email: dlafli@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) physical status I or II adult patients aged 18-65 years undergoing elective arthroscopic anterior cruciate ligament reconstruction will be included in the study.

Exclusion Criteria:

• We will exclude patients with known coagulopathy, allergies to the studied drugs, obesity (BMI >35kg/m2), renal and/or hepatic insufficiency, chronic pain syndrome, mental impairment, depression, chronic alcoholism, and usage of antidepressant and analgesic drugs before surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intrathecal morphine (Group ITM); 12.5-15 mg hyperbaric 0.5% bupivacaine + 0.1 mg (0.1 mL) morphine with a single dose intrathecal injection through the L4-L5 interval (spinal anesthesia) + placebo adductor canal block (with 30 mL saline) will be administered.	Drug: Intrathecal morphine; The study will be conducted in patients undergoing arthroscopic anterior cruciate ligament reconstruction surgery under spinal anesthesia. In this arm, 0.1 mg intrathecal morphine in addition to spinal anesthesia will be used for perioperative pain management. A placebo addctor canal block will also be performed for masking in these patients. The quality of recovery will be evaluated with a postoperative quality of recovery scale (QoR-40 questionnaire) at postoperative 24-hour and 14-day.
Experimental: Adductor canal block (Group ACB); Spinal anesthesia from L4-L5 interval with 12.5-15 mg hyperbaric 0.5% bupivacaine + adductor canal block (30 mL 0.25% bupivacaine) will be applied.	Drug: Adductor canal block; After providing complete sensory block in the lower extremities with spinal anesthesia, the thigh where the surgery will be performed will be brought into slight abduction and external rotation while the patient is in the supine position. The blockage of the saphenous nerve in the adductor canal will be performed with 30 mL of local anesthetic (0.25% bupivacaine) solution with a 22 gauge 5-8 cm long block needle from the mid-medial part of the thigh under ultrasound guidance. The quality of recovery will be evaluated with QoR-40 questionnaire at postoperative 24-hour and 14-day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24-hour Quality of Recovery-40 (QoR-40) questionnaire scores	The score ranges from 40 to 200. A higher score on the QoR-40 means better recovery following arthroscopic anterior cruciate ligament reconstruction.	Postoperative 24-hour.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Supplement analgesia requirement	Amount of additional analgesics taken outside of the usual treatment protocol.	Postoperative 1, 2, 4, 8, 12 and 24-hour.
The time to first postoperative mobilisation	Ambulation time	Duration of postoperative 24-hour
Discharge time	Length of hospital stay	Duration of postoperative 24-hour
Numeric Rating Score (NRS)	Numeric rating score for postoperative pain intensity. Pain intensity will be evaluated using a numeric rating scale with descriptive terms at intervals along a horizontal line of 10 cm length: 0 mm = no pain, 10 cm = worst pain imaginable.	Postoperative 1, 2, 4, 8, 12 and 24-hour.
Treatment satisfaction	Treatment satisfaction will be assessed at 24 h using a 3-point rating scale ranging from 1 to 3: 1 = excellent satisfaction (Numeric Rating Score/NRS=0), 2 = good satisfaction (NRS=1-2), 3 = dissatisfaction (NRS=3-4)	Postoperative 24-hour

Collaborators and Investigators

• Sponsor: Cukurova University

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2023
• Primary Completion (Estimated): September 15, 2023
• Study Completion (Estimated): September 30, 2023

Study Registration Dates

• First Submitted: February 5, 2023
• First Submitted That Met QC Criteria: February 14, 2023
• First Posted (Actual): February 24, 2023

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: quality of recovery; adductor canal block; intrathecal morphine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: Cukurova Univ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Participant code, age, weight, height and information during surgery will be recorded. This information will not be shared with any person or organization.

Drug and device information, study documents

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